No current peripheral neuropathy > grade 2 at time of randomization
Grade 2 or greater peripheral neuropathy
Peripheral neuropathy Grade ? 2
Peripheral neuropathy of any etiology that exceeds grade 1
Ongoing sensory or motor neuropathy Grade ?2.
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Patients must not have baseline peripheral neuropathy that exceeds grade 1
No grade >= 2 peripheral motor or sensory neuropathy
Grade >= 2 neuropathy
=< grade 2 peripheral neuropathy; patients with grade 1 peripheral neuropathy with pain will be excluded
Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
No grade 2 or higher neuropathy
=< grade 2 peripheral neuropathy
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): =< grade 2 peripheral neuropathy
>= Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
Presence of grade > 2 peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
If applicable, patient with >= grade 2 peripheral neuropathy within 14 days before enrollment
Peripheral neuropathy >= 2
Grade >= 2 peripheral neuropathy
Patients with grade 2 or higher peripheral neuropathy will be excluded in the dose escalation phase of the protocol
Patients with a baseline peripheral neuropathy >= grade 2 will not be eligible
Patients must have < grade 2 neuropathy (sensory/motor) within 7 days prior to registration
Patients with preexisting grade II peripheral neuropathy
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not have grade 3 or higher peripheral neuropathy
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not have grade 3 or higher peripheral neuropathy
Baseline neuropathy of > grade 2
Peripheral neuropathy ? Grade 2.
Patients with peripheral neuropathy of grade 2 or higher
Grade >= 2 peripheral neuropathy at the present time
Peripheral neuropathy of Grade 2 within 3 weeks prior to the first study therapy
Subject has preexisting sensory or motor neuropathy Grade ? 2 at baseline
SAFETY RUN-IN: Patients with baseline grade 2 neuropathy
Peripheral neuropathy ?grade 3.
>= grade 3 neuropathy at the time of enrollment
Grade 2 or greater peripheral neuropathy
Peripheral neuropathy >= grade 2 at screening
Subjects with pre-existing grade II peripheral neuropathy
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
Peripheral neuropathy > Grade 2 despite supportive therapy.
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patients who have >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period are not eligible
Participants with grade >= 3 peripheral motor or sensory neuropathy
G>1 pre-existing peripheral neuropathy
Peripheral neuropathy of severity greater than grade 1
Grade 2 or higher peripheral neuropathy at screening
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior cycle 1, day 1
Neuropathy > grade 1
Neuropathy (sensory and motor) less than or equal to CTCAE v4.0, grade 1
Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Patients who have pre-existing motor or sensory neuropathy of a severity ? grade 1 by CTCAE v4.0 criteria
Peripheral neuropathy greater than or equal to Grade 2
Participants with >= grade 2 peripheral neuropathy
Clinically significant peripheral neuropathy at the time of study entry. Patients with pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01
Pre-existing peripheral neuropathy Grade 2 or higher
Baseline peripheral neuropathy of severity > grade 1
Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ? Grade 2, per the CTCAE v4.0.
Grade ? 3 sensory or motor neuropathy.
Patient has ? grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Presence of >= grade 2 peripheral neuropathy
Baseline peripheral neuropathy >= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Peripheral neuropathy >= grade 2
Presence of peripheral neuropathy > grade 1
Patients with > grade 2 sensory peripheral neuropathy.
Peripheral neuropathy =< grade 1 at the time of registration
Pre-existing neuropathy Grade 2 or higher
Neurosensory neuropathy > grade 2 at baseline.
Presence of > grade 1 peripheral neuropathy
Neuropathy ? Grade 2.
Grade 2 peripheral neuropathy or higher or grade 1 with pain on clinical examination during the screening period
Peripheral neuropathy >Grade 2
Patients must not have peripheral neuropathy ? grade 2
Patient has >= grade 2 peripheral neuropathy or neuropathy with pain, regardless of grade that is seen on clinical examination during the screening period
Patients with a history of grade >= 2 neuropathy
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Grade >= 2 peripheral neuropathy
Peripheral neuropathy > grade 1
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
Patients with greater than or equal to grade 2 peripheral neuropathy or active herpes infection
Peripheral neuropathy > CTCAE grade 1
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patients with >= grade 2 neuropathy
Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period
Significant neuropathy > grade 2 at the time of first dose or within 14 days of enrollment
Neuropathy > grade 1
< Grade 2 pre-existing peripheral neuropathy per CTCAE
Peripheral neuropathy ? grade 3 on clinical examination or grade 2 with pain during the screening period
Peripheral neuropathy > grade 2 or > grade 1 with pain on clinical examination during the screening period
Clinically significant (>= grade 2) peripheral neuropathy at the time of study entry
Patients with grade 2 or higher neuropathy
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade less than or equal to 1, except alopecia (any grade) and grade 2 peripheral neuropathy
Patients must not have Grade 2 or higher peripheral neuropathy.
Sensory or motor neuropathy ? grade 2
Patients with pre-existing grade >= 3 peripheral neuropathy
Patients with pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents
Preexisting sensory neuropathy Grade ? 2
Preexisting motor neuropathy Grade ? 2
Peripheral neuropathy grade > 1
Peripheral neuropathy > grade 1, except for grade 2 without limitations on instrumental daily life activities;
Neuropathy (sensory and motor) less than or equal to CTCAE v4.03 grade 1
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to screening
Exclude patients with pre-existing neuropathy grade 2 or higher
Peripheral neuropathy >= grade 3 sensory neuropathy or >= grade 2 sensory neuropathy with pain within 14 days of registration; prior neuropathy of this severity improved due to medical management such as gabapentin are potentially eligible
Patients with grade 2 or greater neuropathy
Has greater than Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (\Balis\) Pediatric Scale of Peripheral Neuropathies.
Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE)
CTCAE grade >= 2 peripheral neuropathy is NOT permitted
Sensory/peripheral neuropathy.
Significant neuropathy (grades 3–4, or grade 2 with pain) within 21 days prior to registration
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Effects of any other prior therapies not reverted to ? Grade 1 (or ? Grade 2 for alopecia and peripheral neuropathy).
Pre-existing peripheral neuropathy of grade II or higher
Grade 3 peripheral neuropathy within 14 days before enrollment.
Peripheral neuropathy Grade 1 with pain or Grade 2 or higher peripheral neuropathy of any cause on clinical examination during the Screening period.
Pre-existing > grade 2 peripheral sensory neuropathy
Active >= grade 3 peripheral neuropathy
Pre-existing sensory neuropathy of grade >= 2
Grade 2 or greater neuropathy
Patients with any baseline grade 2 neuropathy
Peripheral neuropathy > grade 1
Patients with > grade 1 peripheral neuropathy
Sensory or motor neuropathy >= grade 2
Pre-existing grade 3 or 4 neuropathy
Peripheral neuropathy grade 1 or less.
Grade 3 baseline neuropathy
Current Grade greater than (>) 1 peripheral neuropathy by clinical examination
Grade 2 sensory or Grade 1 painful peripheral neuropathy
Ongoing sensory or motor neuropathy Grade 2 or higher.
Neuropathy: patients must have =< grade 1 neuropathy at enrollment
No peripheral neuropathy
Sensory or motor neuropathy >= Grade 2.
Baseline grade II peripheral neuropathy
Peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain during the screening period
Current peripheral neuropathy >= grade 2
Peripheral neuropathy >= grade 2 at screening
Nervous system disorder (i.e., paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Patient has greater than or equal than grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Patient has >= grade 2 peripheral neuropathy on clinical examination during the screening period
Peripheral neuropathy grade 2 or greater
Patients with a peripheral neuropathy > grade 1
Neuropathy =< grade 1 at the time of registration
Diabetic neuropathy (any grade)
Participants with baseline peripheral neuropathy greater than grade 2
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to grade =< 1, except alopecia (any grade) and < grade 2 peripheral neuropathy
Neuropathy grade >1
Pre-existing neuropathy greater than grade 1
Peripheral neuropathy >= grade 2
Baseline grade II peripheral neuropathy
Grade 3 or higher peripheral neuropathy
Patients with greater than or equal to grade 2 peripheral neuropathy at baseline
Significant neuropathy (grades 2 or grade 1 with pain) within 14 days prior to enrollment
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Grade 2 or greater neuropathy
No symptoms attributable to grade 2 or higher peripheral neuropathy
Patients with grade 2 or higher peripheral neuropathy are excluded
Neuropathy >= grade 1
Patient has baseline neuropathy of >= grade 2
Patients with a peripheral neuropathy > grade 1
ENTRECTINIB EXCLUSION CRITERIA: Peripheral neuropathy >= grade 2
Patient has >= grade 2 neuropathy, sensory, with or without pain, motor, or autonomic, on clinical examination during the screening period
Have grade 2 or greater neuropathy at the time of screening
CTCAE grade 3 or higher peripheral neuropathy
Grade >= 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patients must not have > grade sensory neuropathy
Pre-existing peripheral neuropathy of severity grade >= 2 (limiting instrumental activities of daily living)
No baseline peripheral sensory neuropathy >= grade 2
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patient has ? grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Patients with evidence of >= grade 2 peripheral sensory neuropathy
> Grade 1 peripheral neuropathy within 14 days before enrollment.
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Current grade 2 or higher peripheral neuropathy
Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Uncontrolled neuropathy grade 2 or greater, regardless of cause
Pre-existing neuropathy of >= grade 2
Grade >= 2 peripheral neuropathy at baseline (within 21 days prior to cycle 1 day 1)
Patients with peripheral neuropathy of > grade 1
No peripheral edema >= grade 2 at baseline
No peripheral neuropathy >= grade 2 at baseline
Pre-existing grade >= 2 peripheral sensory neuropathy
No prior evidence of grade 3 or greater ototoxicity or neuropathy
No >= grade 2 sensory peripheral neuropathy
Grade 2 or higher peripheral neuropathy.
Significant neuropathy (grades 3–4, or grade 2 with pain)
Neurological assessment for pre-existing peripheral neuropathy
Must not have any significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
Significant neuropathy (grades 3 to 4 or grade 2 pain)
Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living
Patients must not have grade 2 or greater peripheral sensory neuropathy
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
Peripheral neuropathy, if present, should be =< grade 1
Sensory peripheral neuropathy >= grade 2
Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
Significant neuropathy (grade 3, grade 4) at the time of the first dose and/or within 14 days before enrollment
Peripheral neuropathy > grade 1 if due to brentuximab vedotin or any peripheral neuropathy > grade 2
Peripheral neuropathy grade 0-2
Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for alopecia and peripheral neuropathy
Patients with preexisting peripheral neuropathy >= grade 2 are ineligible
Patients with grade >= 2 peripheral neuropathy
Neuropathy (sensory and motor) =< to CTCAE grade 1
Patients with symptomatic peripheral motor or sensory neuropathy >= grade 2 at baseline will receive radiation therapy alone
For the bortezomib arm of the study, patients with grade >= 2 peripheral neuropathy
Patient has >= grade 2 peripheral neuropathy, or grade 1 with pain on clinical examination during the screening period
Peripheral neuropathy > grade 1
Patients with peripheral neuropathy greater than grade II
Patients with grade 2 or higher peripheral neuropathy
Peripheral neuropathy >= grade 1
Pre-existing peripheral neuropathy CTCAE grade 2 or worse
Neuropathy > Grade 1
Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
Has > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (\Balis\) Pediatric Scale of Peripheral Neuropathies
participants with Grade 2 or higher residual toxicities from prior therapy (including Grade 2 or higher peripheral neuropathy or any grade neuropathy with pain; excluding alopecia). This includes recovery from any major surgery. Note: Participants with planned surgical to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
Peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain during the screening period
Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.
Baseline peripheral sensory neuropathy ? grade 2
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to randomization
Has history of Grade 2 or greater peripheral neuropathy during the 3 months prior to enrollment.
Patients who have experienced significant neuropathy (grades 3-4 or grade 2 with pain) within 14 days prior to registration are NOT eligible for participation
Patient has peripheral neuropathy of Grade 3 or greater intensity, or painful Grade 2, as defined by the NCI CTC.
Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4
Patient with peripheral neuropathy Grade >2
Grade 3 sensory neuropathy or motor neuropathy with pain
Grade 2 or higher persisting prior treatment-related neuropathy
Patients with grade 2 or greater peripheral neuropathy.
CTCAE v4 Grade ?2 peripheral neuropathy
Grade 2 or higher peripheral neuropathy
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Grade II or greater neuropathy at baseline
Sensory/motor neuropathy >= grade 2
Sensory/motor neuropathy >= grade 2
Peripheral neuropathy >= grade 2 or clinically significant sensorineural hearing loss or tinnitus
Paclitaxel arm: grade 2 or higher neuropathy
Patients with any of the following adverse events at the time of enrollment are not eligible:\r\n* Grade ? 2 motor, sensory or peripheral neuropathy\r\n* Grade ? 3 hyponatremia (serum sodium [Na] ? 130 mmol/L)
Patient has ? grade 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination during the screening period
Current peripheral neuropathy >= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Grade >= 2 peripheral neuropathy
Preexisting peripheral neuropathy is not allowed from any cause
Participant must have either no neuropathy (sensory and motor) or neuropathy less than or equal to grade 1
Patients with persistent grade 2 or higher peripheral sensory or motor neuropathy of any cause
Grade >= 2 peripheral neuropathy
Pre-existing peripheral neuropathy grade ?= 2 at registration
Patients with >= grade 2 neuropathy
Sensory or motor peripheral neuropathy >= grade 2
No grade >= 2 neuropathy
Ongoing grade >= 3 neuropathy
Grade 2 or higher peripheral neuropathy.
>= grade 2 peripheral neuropathy
Peripheral neuropathy >= grade 2 despite supportive therapy
Sensory or motor neuropathy >= grade 2
Central nervous system (CNS) toxicity including peripheral neuropathy =< grade 2
Subject has preexisting sensory or motor neuropathy Grade ? 2 at baseline
Subjects with grade 2 or greater neuropathy
Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
Peripheral neuropathy of severity greater than grade 1
Baseline of grade 2 or worse peripheral sensory neuropathy
Motor peripheral neuropathy = grade 0 (per CTCAE v. 4.0)
Greater than grade 1 peripheral neuropathy at baseline
Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period
Patients with existing grade 3 or 4 peripheral neuropathy
Baseline neuropathy > grade 1
Peripheral neuropathy >= grade 2 at baseline OR peripheral neuropathy >= grade I with neuropathic pain
Patients with grade 3/4 peripheral neuropathy
Patients who have baseline peripheral neuropathy >= grade 2 are not eligible
Patient has baseline neuropathy of > grade 2
Grade > 2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1)
Subject has >= grade 2 peripheral neuropathy
Peripheral neuropathy >= grade 2
Grade 2 or higher peripheral neuropathy
Patients must not have a pre-existing > grade 1 motor or sensory neuropathy
PHASE II: Patients must not have a pre-existing > grade 1 motor or sensory neuropathy
Patients with > grade 1 peripheral sensory neuropathy or > grade 1 peripheral motor neuropathy graded according to the Modified (“Balis”) Pediatric Scale of Peripheral Neuropathies are not eligible
Patient has >= grade 2 peripheral neuropathy within 14 days of trial enrollment
Patient has >= grade 3 peripheral neuropathy, or >= grade 2 with pain on clinical examination during the screening period
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Pre-existing grade 2 or greater neuropathy
Grade 2 or greater neuropathy
Pre-existing peripheral neuropathy > grade 2 with pain (CTC version 4.0).
Neuropathy (sensory and motor) =< grade 1
Peripheral neuropathy >= grade 2
Peripheral neuropathy >= grade 2
Peripheral neuropathy =< grade 1
>= grade 2 peripheral neuropathy
>= grade 2 peripheral neuropathy within 14 days before beginning maintenance therapy
Pre-existing peripheral motor or sensory neuropathy >= grade 2
Pre-existing grade >= 1 peripheral neuropathy
Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy
Neuropathy (sensory and motor) less than or equal to Grade 1.
Patients with >= grade 2 peripheral neuropathy
Peripheral neuropathy grade 2 or greater
Patients must not have grade 2 or higher peripheral neuropathy
Participant with sensory peripheral neuropathy of ? Grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
Patients must not have peripheral neuropathy >= grade 2
Patients with peripheral neuropathy > grade 2 regardless of etiology
Has peripheral neuropathy ? Grade 2.
Peripheral neuropathy >= grade 2 on clinical examination, within 21 days of initiation of protocol therapy
Peripheral neuropathy =< grade 1
Neuropathy Grade > 3
Has peripheral neuropathy ? Grade 2
Grade 2 or greater neuropathy [Applies to Phase 1]. Grade 3 or greater neuropathy [Applies to Phase 2].
Subjects with baseline peripheral neuropathy that exceeds grade 1
Significant symptoms (grade >= 2) peripheral neuropathy
Preexisting sensory grade 3 neuropathy
Pre-existing neuropathy of at least Grade 2
Peripheral neuropathy ? Grade 3 or ? Grade 2 with pain within 2 weeks prior to first dose
Peripheral neuropathy ? Grade 2
Peripheral neuropathy ? Grade 2.
Preexisting sensory neuropathy Grade ? 2 or motor neuropathy Grade ? 2
Has peripheral neuropathy ? Grade 2
Patients who have had grade 2 or higher peripheral neuropathy within 14 days prior to registration are not eligible (must have resolved to grade 1 or lower to register)
Peripheral neuropathy or neuropathic pain Grade 2 or higher
Current Grade >1 peripheral neuropathy
Grade <= 2 neuropathy
Grade ? 2 peripheral neuropathy
Neuropathy uropathy europathy Nemediastinal DLBCL.
Neurosensory neuropathy ? grade 2 at baseline.
Less than Grade 2 pre-existing peripheral neuropathy
Pre-existing neuropathy from any cause in excess of Grade 1.
Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
Patients with > grade 1 neuropathy
Peripheral neuropathy < grade 2
Subjects with >= grade 2 neuropathy
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment and at D60-180 after AHCT; patients who had >= grade 2 peripheral neuropathy within 14 days before enrollment but resolves to grade 1 or lower peripheral neuropathy at D60-D180 after AHCT can be enrolled at this time
Pre-existing peripheral neuropathy >= Common Terminology Criteria (CTC) grade 2 for those patients who received prior paclitaxel
Known peripheral neuropathy > grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
Grade >= 2 peripheral neuropathy
Current Grade >1 peripheral neuropathy from any cause
Evidence of ? Grade 2 neuropathy
Patients must not have peripheral neuropathy > grade 2
Peripheral neuropathy exclusions
? Grade 2 peripheral neuropathy
Baseline peripheral neuropathy/paresthesia grade >= 1
Patient has >= grade 2 peripheral neuropathy
Neuropathy > Grade 1.
Patients with symptomatic neuropathy
Patients with >= grade 2 neuropathy
Patient has >= grade 2 peripheral neuropathy
Sensory or motor peripheral neuropathy
Grade 2 or greater neuropathy
Patients must not have grade 2 or greater peripheral neuropathy
Serious peripheral neuropathy.
Uncontrolled neuropathy grade 2 or greater regardless of cause.
Preexisting sensory grade >= 2 neuropathy
Peripheral neuropathy- grade 2 or greater
Peripheral neuropathy ? Grade 2.
Patients must have < Grade 2 or pre-existing neuropathy (per CTCAE).
Peripheral neuropathy grade 2 or greater
Resolution of (non-laboratory) adverse effects of recent surgery, radiotherapy, or chemotherapy to grade =<1 prior to first study treatment (with the exception of alopecia or neuropathy; chemotherapy-induced peripheral neuropathy up to grade =< 2 will be permitted)
Pre-existing Grade greater than (>) 1 neuropathy
Patient has >= grade 1 peripheral neuropathy with pain on clinical examination during the screening period
Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
Participants who have more than grade 1 peripheral neuropathy
Current peripheral sensory neuropathy > grade 1
Peripheral neuropathy >= grade 2
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Neuropathy grade 2 or higher
Peripheral neuropathy < grade 2
Neuropathy (sensory and motor) less than or equal to grade 1
Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
Significant neuropathy (? Grade 3) within the 14 days prior to randomization
Clinically significant peripheral neuropathy
Has baseline peripheral neuropathy/paresthesia grade ? 1.
Participant has >= grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
Evidence of peripheral neuropathy of Grade >2.
Grade 2 or higher peripheral neuropathy (paclitaxel arm only)
Pre-existing peripheral neuropathy (grade I or higher)
Patients with grade 2 peripheral neuropathy or greater are excluded
Patients with Grade 2 or greater pre-existing neurologic abnormalities (CTCAE version 4.0), including Grade 2 or greater peripheral neuropathy caused by previous treatments.
Neuropathy (sensory and motor) less than or equal to grade 1
Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
Subjects with >= grade 2 neuropathy
Subject has peripheral neuropathy ? grade 2.
Peripheral neuropathy >= grade 1
Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
Grade 3 or above peripheral neuropathy
Peripheral neuropathy: must be =< grade 1
Grade > 2 peripheral neuropathy at baseline
Grade >= 2 peripheral neuropathy within 14 days prior to cycle 1 day 1
Patients with existing peripheral neuropathy grade > 2
Preexisting sensory and/or motor neuropathy Grade ? 2
Peripheral neuropathy =< grade 1 at the time of registration
Existence of peripheral sensory neuropathy >= grade 2 (from any cause)
The patient has peripheral neuropathy >= grade 2
Patients with grade II or greater peripheral neuropathy will be excluded from study
Grade >= 2 peripheral neuropathy within 14 days prior to initiation of therapy
Patient has > grade 2 peripheral neuropathy on clinical examination during the screening period
Subject has peripheral neuropathy >= grade 2.
Presence of peripheral neuropathy ? CTCAE Grade 2
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to the first day of treatment
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Neurosensory neuropathy ? grade 2 at baseline
No significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to cycle 1 day 1
Peripheral neuropathy ? Grade 2 despite supportive therapy
Participant has >= grade 2 peripheral neuropathy on clinical examination within 21 days before initiation of protocol therapy
Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
Has baseline peripheral neuropathy/paresthesia
COHORT II: Patients must not have >= grade 2 peripheral neuropathy
Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to signing consent
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of first dose
> Grade 3 neuropathy
Peripheral neuropathy > Grade 2.
Current grade II or higher peripheral neuropathy.
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
Subjects with pre-existing grade 3 or 4 neuropathy; any peripheral neuropathy must recover to grade =< 1 before enrollment
Patients with grade 2 sensory neuropathy at baseline
Pre-existing grade 3 or 4 sensory neuropathy
Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
Grade >= 2 peripheral neuropathy within 21 days before enrollment
Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to enrollment
Patient has >= grade 3 peripheral sensory neuropathy or >= grade 2 painful sensory neuropathy within 14 days before enrollment; (NOTE: patient with peripheral neuropathy [PN] that was previously this severe but is currently improved due to ongoing therapy [e.g., gabapentin or amitriptyline] may be eligible)
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
Pre-existing neuropathy greater than grade 1
Patients with greater than or equal to grade 2 peripheral neuropathy at baseline
Patient must not have >= grade 2 peripheral neuropathy within 14 days before enrollment
Patient has >= grade 2 peripheral neuropathy
Pre-existing neuropathy greater than grade 1.
Pre-existing neuropathy grade III or greater
Grade >= 2 sensory neuropathy at the time of enrollment
No peripheral or sensory neuropathy > grade 1 at study entry
Grade >1 neuropathy
Preexisting sensory grade >= 2 neuropathy
Peripheral neuropathy greater than Grade 1
Peripheral neuropathy >= grade 2 at baseline OR peripheral neuropathy >= grade I with neuropathic pain
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
Pre-existing neuropathy from any cause in excess of Grade 1
No peripheral neuropathy greater than grade 1, due to any cause
Patient has >= grade 2 (CTCAE v 4.0) peripheral neuropathy within 14 days before enrollment
History of Grade ?2 neuropathy
Patient has >= grade 2 peripheral neuropathy on clinical examination within 28 days of signing consent
Peripheral neuropathy: must be =< grade 1
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Grade 2 or more peripheral neuropathy
Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also excluded
Peripheral neuropathy ? Grade 2
Patient has baseline neuropathy of >= grade 2
Peripheral neuropathy >= grade 3
Neuropathy (sensory and motor) less than or equal to grade 1
Significant peripheral neuropathy defined as grade 2 or higher
No ? grade 2 peripheral neuropathy.
Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Neuropathy > grade 2
Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment.
CTCAE version 4.03 > grade 3 peripheral neuropathy
Peripheral neuropathy =< grade 1
Significant neuropathy >= grade 3 or grade 2 neuropathy with pain at baseline
Patient has grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period
Pre-existing peripheral neuropathy >= grade 2
Peripheral neuropathy >= grade (Gr) II
Subject has > grade 2 peripheral neuropathy within 14 days before enrollment
? Grade-2 neuropathy
Grade >= 2 peripheral neuropathy within 14 days before enrollment
Peripheral neuropathy =< grade 1
Peripheral neuropathy >/= Grade 2 (NCI-CTC Version 3.0)
Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
No grade 2 >= peripheral neuropathy within 14 days before enrollment
?Grade 2 sensory neuropathy at baseline
Neuropathy (sensory and motor) less than or equal to CTCAE v 4.0 grade 1
Grade 3 peripheral neuropathy
Patient has >= grade 2 peripheral neuropathy
Patients with peripheral neuropathy of grade >= 3; patients with painful grade 2 neuropathy are also excluded
No current grade 2, 3, or 4 of neuropathy
Peripheral neuropathy
Patient has >= grade 3 peripheral neuropathy, or grade 2 peripheral neuropathy with pain on clinical examination during the screening period
Peripheral neuropathy > grade 2
Current grade II or higher peripheral neuropathy.
Peripheral neuropathy that is grade 2 or higher
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade </= 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
> grade 2 peripheral neuropathy at baseline
Peripheral neuropathy of grade 2 or greater
Presence of ? Grade 2 peripheral neuropathy
Peripheral neuropathy ? Grade 3.
Presence of clinically significant non-hematological toxicity of prior chemotherapy that has not resolved to ? Grade 1 as determined by CTCAE v 4.0, with the exception of alopecia and peripheral neuropathy. Note: Peripheral neuropathy > Grade 2 plus pain, or Grade 3 or Grade 4 are excluded.
Evidence of baseline sensory or motor neuropathy
Presence of > Grade 1 peripheral neuropathy
Grade 3 or higher peripheral neuropathy
Peripheral neuropathy CTCAE Grade ?2
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Peripheral neuropathy ? Grade 2
Patients with any neuropathy > Grade 1
Patients with grade > 2 neuropathy attributable to previous administration of taxane chemotherapy
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
have persistent Grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening
Peripheral edema > grade 1
Patients with peripheral neuropathy > 2
Baseline peripheral neuropathy ? grade 2.
Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
Clinical evidence of neuropathy
Peripheral neuropathy ? grade 2.
Grade >= 2 peripheral neuropathy
Evidence of sensory and/or peripheral neuropathy > grade 1
If applicable, patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment
Neuropathy (sensory and motor) =< CTCAE v4.03 grade 1
Significant neuropathy >= grade 3 at baseline
Peripheral neuropathy greater than grade 1
Patients with grade >= 2 peripheral neuropathy will not be permitted on study
Patients with any neuropathy.
Patients with preexisting peripheral neuropathy grade >= 2 will not be eligible
Grade ? 2 sensory neuropathy
Evidence of peripheral neuropathy of Grade > 2
Subjects with > grade 1 peripheral neuropathy
Significant peripheral sensory or motor neuropathy at the start of the study.
Patients with > grade 2 neuropathy according to the Modified (“Balis”) Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
Patients with neuropathy > grade 1
Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to Day 1
Peripheral neuropathy Grade >/=2
Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment
Grade 2 or higher neuropathy
Current/ongoing Neuropathy (sensory or motor) Grade > 1 or any history of Grade ? 3 neuropathy with prior Vincristine or chemotherapy exposure (documentation by history is adequate to exclude)
Presence of peripheral neuropathy
Greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
Subject has Neuropathy ? Grade 2 at Screening.
Subjects with Grade >2 peripheral neuropathy
Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Criteria for Adverse Events (CTCAE) v4.0).
Peripheral neuropathy at study entry
>= grade 2 pre-existing peripheral neuropathy (per CTCAEv4)
Peripheral neuropathy CTCAE v4.03 Grade ? 3
Patients with peripheral neuropathy >= grade 2
Patients with greater than 2 screening peripheral neuropathy
Peripheral neuropathy ? CTCAE Grade 2 at baseline.
Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
Patients who have grade >= 2 peripheral neuropathy
Preexisting grade >= 2 peripheral neuropathy
Patients with peripheral neuropathy >= grade 2 are not permitted unless discussed with the principal investigator and only in unique circumstances (i.e. unilateral neuropathy due to trauma)
With < or = grade 2 neuropathy
> grade 2 neuropathy
Current grade 3 or higher neuropathy
Grade 2 or higher peripheral neuropathy
Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
Grade ? 2 sensory neuropathy
Patients with grade III-IV neuropathy
Significant neuropathy (grades 3 to 4, or grade 2 pain)
No grade >= 2 peripheral neuropathy
Patient has >= grade 2 peripheral neuropathy
Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to randomization
Grade 2 or above neuropathy
Grade >=2 peripheral neuropathy
Presence of ? Grade 2 neuropathy.
Baseline peripheral edema >= grade 3
Pre-existing peripheral neuropathy grade >= 2
Neuropathy Grade 3 or more
Part 2 only: Patients with >= grade 2 peripheral neuropathy.
If applicable, patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
Significant peripheral neuropathy (Grade 3, Grade 4, or Grade 2 with pain) within 14 days prior to first dose
Grade 2 or higher peripheral neuropathy at the time of study entry
Peripheral neuropathy ?Grade 2.
Significant neuropathy (grades 3–4, or grade 2 with pain) within 14 days prior to randomization
>= grade 2 peripheral neuropathy
Peripheral neuropathy >= grade 2 on clinical examination during the screening period
Peripheral neuropathy
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
Patients with a >= grade 2 peripheral neuropathy
Current Grade >1 peripheral neuropathy
History of peripheral neuropathy; (note: this does not apply to Cohort 3)
Grade >=2 peripheral neuropathy
Patients with peripheral neuropathy >= grade 2
Grade ?2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater
Grade 2 or greater peripheral neuropathy
Peripheral neuropathy >= grade 2
Patient has >= grade 2 peripheral neuropathy within 14 days prior to treatment initiation
Peripheral neuropathy that is greater or equal to Grade 2
Has peripheral neuropathy that is greater or equal to Grade 2
Pre-existing peripheral neuropathy greater than CTCAE Grade 2.
Patient has > Grade 2 painful neuropathy or peripheral neuropathy
Peripheral neuropathy ? Grade 2
Patients with peripheral neuropathy > grade 1 will be excluded from study participation
The participant has any Grade 2 (or greater) peripheral neuropathy.
Evidence of grade 2 or greater sensory and/or peripheral neuropathy
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
Pre-existing >= grade 2 peripheral neuropathy
Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
No grade 2 or greater peripheral neuropathy.
Grade >= 2 neuropathy
History of peripheral neuropathy of ?grade 2
Patients with symptomatic peripheral neuropathy> Grade 1.
No evidence of peripheral or sensory neuropathy
Grade 2 or greater motor or sensory neuropathy
Patient does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2); peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed
Peripheral neuropathy > grade 1 (NCI-CTC).
Peripheral neuropathy of > grade 2 severity.
Peripheral neuropathy ? CTCAE grade 2
Peripheral neuropathy with grade =< 1
Neuropathy >= grade 2 (moderate neuropathy that limits instrumental activities of daily living)
Clinically significant (>= grade 2) peripheral neuropathy at the time of study entry
Patients with >= grade 2 sensory or motor neuropathy are not eligible
Significant neuropathy (grades 3 - 4, or grade 2 with pain) within 14 days prior to enrollment
Neuropathy (sensory or motor) less than or equal to grade 1
Patient has pre-existing peripheral neuropathy Grade >1
Peripheral neuropathy >= grade 1
Grade >= 2 peripheral neuropathy
Patients must not have a history of peripheral neuropathy (regardless of cause)
Pre-existing symmetric peripheral painful neuropathy
Any peripheral neuropathy >= grade 3
Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy
Grade III or IV upper extremity peripheral neuropathy
Self-report of >= 4 on the Peripheral Neuropathy Question
Presence of pain primarily due to chemotherapy induced peripheral neuropathy
Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy.
History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
Pain or symptoms of peripheral neuropathy of > 3 month's duration attributed to chemotherapy-induced peripheral neuropathy
SCREENING PHASE: Pre-existing peripheral neuropathy within 28 days of screening consent
INTERVENTION PHASE: Pre-existing peripheral neuropathy within 28 days of screening consent
Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
Pre-existing grade 2 or greater neuropathy
Neuropathy: no baseline neuropathy grade > 2
Peripheral neuropathy greater than or equal to grade 2.
History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, human immunodeficiency virus (HIV), congenital neuropathy, toxic neuropathy
Known diabetic neuropathy
Patient with >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Grade 2 or higher peripheral neuropathy
Grade II or higher neuropathy
No >= grade 2 peripheral neuropathy
Peripheral neuropathy ? grade 2
Peripheral neuropathy greater than grade 1
Patients with > grade 2 sensory peripheral neuropathy
Patients with ? grade 2 sensory peripheral neuropathy
Sensory/motor neuropathy ? Grade 2
Have pre-existing peripheral neuropathy from other medical conditions or due to cancer
Greater than Grade 2 neuropathy or ? Grade 2 neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication
Peripheral neuropathy greater than grade 1
Pre-existing sensory neuropathy > grade 1
Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
Neuropathy with or without pain
Current or prior history of grade ? 2 peripheral sensory and/or motor neuropathy.
Has neuropathy ? Grade 2.