Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the investigator should not exclude the participant a. Any known history of Grade 4 thrombocytopenia with any prior chemotherapy regimen
With the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy greater than CTCAE grade 1 at time of study treatment
At least 2 weeks since the last systemic therapy regimen prior to enrollment. Subjects must have recovered to NCI CTCAE v4.03 Grade 1 or less from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
Resolution of treatment-related toxicities
At least 1 week since the last systemic therapy regimen prior to Cycle 1 Day 1. Subjects must have recovered to NCI CTCAE v. 4.03 < Grade 2 from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
All clinically significant toxicities from prior systemic therapy must be =< grade 1 (with the exception of alopecia, endocrinopathies associated with prior immunological therapies as long as they are stable with replacement therapy, and peripheral neuropathy, which may be =< grade 2)
Recovery from prior treatment-related toxicities
Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
Toxicities due to prior therapy must be stable and recovered to =< grade 1 (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator’s ability to assess treatment emergent toxicities)
The patient has persistent clinically significant ?Grade 2 toxicities from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy which is permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
Ongoing prior toxicities related to previous treatments must be recovered to < grade 2 at the time of registration (with the exception of alopecia, grade 2 peripheral neuropathy or lymphopenia)
Insufficient recovery from all active toxicities of prior therapies
Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia.
Resolution of all chemotherapy or radiation-related toxicities to ? Grade 1
Resolution of all clinically significant treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to =< grade 1 prior to the first dose of study treatment
> 21 days from therapeutic radiation or chemotherapy (>6 weeks from nitrosoureas and mitomycin C) and recovery to (NCI CTCAE v4.03) Grade ? 1 from all clinically significant toxicities related to prior therapies.
Resolution of treatment-related toxicities.
All persistent clinically significant toxicities from prior chemotherapy must be less than or equal to grade 1
Has been receiving erlotinib, gefitinib, or afatinib for at least 6 weeks with well-controlled related toxicities less than Grade 3 in severity at the time of screening period.
Toxicities due to prior therapy must be stable and recovered to =< grade 1 (except for clinically non significant toxicities such as alopecia)
Resolution of all treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to < grade 1 prior to the first dose of study treatment
Resolution of all toxicities from prior therapy to ?Grade 1 (or baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ?Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
Recovery to =< grade 1 from all toxicities associated with prior therapy except alopecia
Patients with active infection, un-resolving more than grade 2 transplant-related toxicities
Baseline toxicities from prior anti-cancer treatments > grade 1
Has no prior treatment-related toxicities >Grade 1 (except alopecia) at the time of enrolment.
Resolution of all treatment-related toxicities, except alopecia, anemia and neuropathy, from any previous cancer therapy to ? Grade 1 prior to the first dose of study treatment.
No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy
Non-hematological toxicities ? Grade 2
Patients must have recovery from other clinically significant, non-hematologic toxicities to =< grade 2
Recovery from >= grade 2 toxicities of prior therapy regimen to grade 1 or baseline, with the exception of anemia and lymphopenia and chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of gemcitabine, sorafenib, and vorinostat (eg, alopecia, changes in pigmentation, stable endocrinopathies); patients with =< grade 2 peripheral sensory or motor neuropathy are eligible
All prior treatment-related toxicities must be =< grade 1
Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for alopecia and peripheral neuropathy
Insufficient recovery from all active toxicities of prior therapies
Hydroxyurea may be used to control leukocytosis and can be taken until day 1 of therapy; patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade 2 are eligible, but must be documented as such
Clinically significant toxicities from prior chemotherapy must not be greater than grade 1
Patients must demonstrate resolution of all toxicities related to prior chemotherapy, endocrine therapy, or biologic therapy to grade =< 1, including peripheral neuropathy, with the exception of alopecia (any grade permissible)
Prior treatment with an investigational agent is allowed but must have been completed >= 28 days prior to randomization with resolution of all treatment-related toxicities to grade =< 1.
Prior radiotherapy must be completed >= 14 days prior to randomization with documentation of adequate recovery from associated toxicities to grade =< 1
Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
Persistent toxicities caused by previous cancer therapy; toxicities should have recovered to =< grade 1, excluding alopecia and stable chronic grade 2 toxicity that is not overlapping with presumed toxicities of olaparib
Persistent toxicities >= grade 3 from prior chemotherapy or biological therapy regardless of interval since last treatment
Recovery to =< grade 1 toxicities associated with prior therapy
All prior treatment-related toxicities must be CTCAE v4 grade =< 1 (except alopecia) at the time of randomization
Patients must have recovered from all non-hematologic toxicities to =< grade 2 and from all hematologic toxicities to =< grade 3 prior to registration
Recovery to from toxicities related to any prior treatments.
The patient has persistent clinically significant toxicities Grade ? 2 from previous chemotherapy (excluding alopecia, nausea, fatigue, and liver function tests (as mandated in the inclusion criteria)).
All prior treatment-related toxicities must be CTCAE v4 grade =< 1 (except alopecia) at the time of randomization
Resolution of all toxicities related to prior therapies to ? NCI-CTCAE Grade 1 severity, except for alopecia, vitiligo, or endocrinopathies on replacement therapy.
Baseline toxicities from prior anti-cancer treatments > grade 1
Resolution of treatment-related toxicities except alopecia
A minimum of two weeks since last dose of most recent RCC therapy assuming resolution of clinically significant treatment-related toxicities to grade 1, baseline, or controlled with supportive medications
Recovered from all toxicities associated with prior treatment, to acceptable baseline status or grade 1 or less, except for toxicities not considered a safety risk, such as alopecia or vitiligo; peripheral neuropathy must be grade 2 or less
Recovery to =< grade 1 toxicities associated with prior therapy
With the exception of alopecia or toxicities related to the use of gonadotropinreleasing hormone agonists, any unresolved toxicities from prior therapy greater than CTCAE Grade 2 at the time of starting study treatment.
Grade 2 or greater toxicities from prior therapy, except for Grade 2 toxicities that are not expected to resolve and that in the judgment of the Investigator do not pose a significant safety risk to subject participation.
Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
Recovery from non-hematological toxicities of prior therapy (including HSCT) to no more than grade 1 (except alopecia)
Recovery to =< grade 1 from all significant toxicities of previous therapies
Resolution of all chemotherapy or radiation-related toxicities to grade 1 severity or lower except for alopecia
Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
Participants may have received radiotherapy for palliative purpose, but must not be experiencing > grade 1 treatment related toxicities, and must have completed treatment > 14 days prior to registration
Adequate recovery of drug related toxicities, surgery or radiation therapy
Recovery to Grade 1 from all clinically significant adverse events related to prior MF therapy, including transplant-related toxicities.
All clinically significant toxicities from prior chemotherapy must be ? Grade 1.
The interval from prior treatment to time of study drug administration is at least 1 week (except for hydroxyurea or steroid therapy) with recovery from all prior therapy-related toxicities
Ongoing toxicities >= grade 2 from prior therapy
Resolution of prior treatment associated toxicities to ? grade 1
At least 2 weeks since last cytotoxic chemotherapy, hormonal therapy, or radiotherapy; toxicities related to prior therapy must either have returned to grade 1, or baseline (excluding alopecia)
Patients should be without any persisting clinically significant > grade 2 hematological/non hematological toxicities from previous treatments that would preclude evaluation of toxic effects of study treatment; grade 1 residual toxicity will be acceptable; patients should be off previous treatment at least 2 weeks from prior therapies before treatment start
Resolution of all prior treatment-related toxicities to Grade 1 or less, except for Grade 2 fatigue or alopecia prior to C1D1
For Part A only: Participants who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities which, in the opinion of the Investigator, should not exclude the patient.
Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.
Inadequate recovery from any toxicities related to prior treatment (to grade 1 or baseline)
Prior treatment toxicities must be ? Grade 1
Resolution of all prior ONT-10 related toxicities to ? Grade 1in severity
Recovery to =< grade 1 toxicities associated with prior therapy
The patient has persistent and clinically significant Grade ?2 toxicities from induction or consolidation therapy (excluding alopecia, nausea, fatigue, and liver function tests [as mandated in the inclusion criteria]) not readily managed with supportive measures.
Patients with existing grade 2 toxicities, except as approved by the investigator
Failure to recover from all prior treatment-related non-hematological toxicities to ? Grade 1 prior to the first scheduled dose of MEDI7247 (except for alopecia and neuropathy).
Subject that has toxicity from previous anti-cancer therapy must have recovered to ? Grade 1 (except for non-clinically significant toxicities, e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled.
SUBJECT: Must be off anti-neoplastic therapy for at least 2 weeks and all therapy-related toxicities should return to baseline or =< grade 1 if previously nonexistent.
Has been receiving erlotinib for treatment of NSCLC with erlotinib-related toxicities well-controlled and less than Grade 3 in severity at screening
Persistent clinically significant grade >= 2 toxicities (as per >= CTCAE v4) related to prior cancer therapy
All toxicities should recover to grade 0 or 1 prior to day 1
Has been receiving erlotinib, gefitinib, afatinib, or osimertinib for at least 6 weeks with well-controlled related toxicities less than Grade 3 in severity at the time of Screening
Toxicities due to prior therapy must be recovered to baseline or ? grade 1, except for clinically non-significant toxicities such as alopecia
Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to ? Grade 1 by C1D1.