[c09aa8]: / clusters / 9knumclustersv2 / clust_1099.txt

Download this file

193 lines (192 with data), 16.5 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
Previous exposure to pralatrexate.
History of exposure to certain cumulative doses of anthracyclines
Participant has prior exposure to any pyrrolobenzodiazopine-containing agent
Prior exposure to a bromodomain inhibitor, such as OTX- or CPI-.
Prior exposure to a WNT inhibitor
More than month of prior hormone exposure or hormone exposure within days of registration; prior enzalutamide, ketoconazole, abiraterone, or TAK prohibited; prior alpha-reductase inhibitors are allowed
All pts must be counseled at a minimum of every days about pregnancy precautions and risks of fetal exposure.
No prior exposure to immunotherapy agents
Prior exposure to isatuximab or participation in clinical studies with isatuximab.
Subjects must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation.
Be counseled about pregnancy precautions and risks of fetal exposure and agree to requirements of the Pregnancy Prevention and Risk Management Plan (PPRMP)
Concurrent exposure to any commercially available agents known to be active against SMM and MM
Prior exposure to ibrutinib or ulocuplumab
Prior exposure to CWP.
Patients must not have received prior exposure to VX/
Participants who have had prior exposure to ibrutinib
prior IMiD exposure
Prior exposure to ixazomib; however, prior bortezomib exposure is allowed
Prior exposure to Astellas ASP.
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Exposure to household contacts =< months old or household contact with known immunodeficiency
Prior exposure to panitumumab in any setting
Prior exposure to immune-mediated therapy
No prior treatment with a hypomethylating agent, or previous exposure to DEC-/NY-ESO- fusion protein CDX- (CDX-)
Prior exposure to agents targeting IL- or the IL- receptor
Prior exposure to a bromodomain inhibitor, such as OTX- or CPI-
Exposure to any investigational drug or placebo within weeks of enrollment
Subjects must have progression within months of platin exposure during definitive or palliative therapy.
Prior and concomitant therapy:\r\n* Prior exposure to any PI kinase inhibitor\r\n* Exposure to chemotherapy, radiotherapy, or immunotherapy within weeks prior to entering the study or lack of recovery from adverse events due to previously administered treatments\r\n* Ongoing chronic pharmacologic immunosuppression, e.g. cyclosporine, or systemic steroids that have not been stabilized to the equivalent of =< mg/day prednisone prior to the start of the study drug\r\n* Other concurrent investigational agents during the study period
Exposure to household contacts =< months old or household contact with known immunodeficiency
If previously exposed to irradiation, the combined prior and anticipated exposure for Cycle is not expected to exceed organ exposure limits outlined in Table
Patients with prior or current history of digoxin exposure
Patient with history of prior exposure to decitabine
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Prior exposure to docetaxel, selinexor, or another selective inhibitor of nuclear transport (SINE) compound
All participants who are prescribed lenalidomide or pomalidomide must be counseled at a minimum of every - days about pregnancy precautions and risks of fetal exposure (Cohorts B, C, E, F)
Prior exposure to CYP (other than ketoconazole) or PARP inhibitors for prostate cancer; patients with prior exposure to ketoconazole are eligible
Exposure to any new immunosuppressive medication in the weeks prior to enrollment
For Combination therapy, participant must not have had prior exposure to Rovalpituzumab Tesirine or a pyrrolobenzodiazepine (PBD) based drug.
Prior exposure to BP
Prior exposure to IACS- or other oxidative phosphorylation inhibitors
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Patients with exposure to prior immunotherapy are not eligible
Prior exposure to a short interspersed element (SINE) compound
Prior exposure to BP
Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
Previous exposure to toll-like receptor (TLR) agonist therapy
Exposure to another CD targeting drug.
Any prior to exposure to ruxolitinib
Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue- (EZH)
ARM C COHORT : Patients must not have prior cisplatin exposure
Patient must not have had prior exposure to gene vector delivery products within months.
Exposure to any systemic chemotherapy within days of date of randomization.
Exposure to household contacts =< months old or household contact with known immunodeficiency
Prior exposure to thiazolidinedione (TZD) therapy in the past months
Prior exposure to CMC- within past months
Prior therapeutic radiation exposure to tissues for which protocol irradiation is anticipated is an exclusion criterion
Exposure to more than one prior anti-tubulin/microtubule agent
Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug
Previous exposure to vinorelbine (applicable for Cohort triplet combination only)
Prior exposure to isatuximab or participated clinical studies with isatuximab.
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within months prior to the administration of study drug.
Any prior exposure to HuF?G or other CD targeting agents.
Had prior exposure to gene vector delivery products within months
Previous selinexor exposure
Prior exposure to carboplatin (related to current or past diagnosis)
Prior exposure to chemotherapy or radiation for the disease to be treated on this trial not allowed
Prior exposure to eribulin mesylate
Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
Exposure to household contact with known immunodeficiency
Current exposure to household contacts =< months old or household contact with known immunodeficiency
Exposure to household contacts =< months old or household contact with a person with known immunodeficiency
Patients enrolled to the prior treatment arm of the expansion cohort must have been exposed to a tyrosine kinase inhibitor (TKI) for metastatic disease; exposure to TKI as part of (neo)adjuvant treatment that completed within year of study qualifies as prior exposure as well
Prior exposure to ibrutinib or other ITK inhibitors
Previous exposure to vandetanib
Exposure to household contacts =< months old or household contact with known immunodeficiency
Prior non-taxane or platinum containing chemotherapy will be allowed if the prior exposure was at least years ago and the exposure is thought not to potentially interact with the primary outcome of the trial or put the patient at undue risk, and should be reviewed with study principle investigator (PI) on a case by case basis
Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin dose modification
Any IFN- containing agent within weeks prior to screening or any prior exposure to HCV-specific antivirals agent(s), other than NS/A protease inhibitor and sofosbuvir
No previous exposure to any formulation of interferon
No previous exposure to any formulation of pegylated interferon
At the time of tumor recurrence, patients with CIS alone or high-grade Ta/T with CIS should be within months of last exposure to BCG and patients with Ta/T without CIS should be within months of last exposure to BCG
Prior exposure to any CSFR pathway inhibitors
Has had prior exposure to tazemetostat or other inhibitor(s) of EZH
Prior exposure to ibrutinib or to a BCR inhibitor or a BCL- inhibitor.
Prior exposure to EGFR inhibitors.
Prior exposure to bromodomain (BET) inhibitors
Previous exposure to chemotherapy for rectal cancer
History of exposure to the cumulative doses of anthracyclines
Prior exposure to a BCL- inhibitor (eg, venetoclax/ABT-)
Previous single agent exposure to the selected chemotherapy regimen for randomisation.
Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homolog (EZH)
Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue- (EZH)
No prior exposure to immune-mediated therapy,
History of prior cumulative exposure to >= mg/m^ cisplatin, area under the curve (AUC) of of carboplatin, or their combined equivalent within one year prior to enrollment
Prior exposure to any bromodomain (BET) inhibitors
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within months prior to the administration of study drug
Exposure to any IP during the last weeks prior to enrollment.
Any prior exposure to neurotoxic chemotherapy
Prior exposure to immune-mediated therapy
Patient has had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
Prior exposure to PM
Prior exposure to idelalisib
Prior exposure to an immunomodulatory agent (IMiD)
Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PIK inhibitors is acceptable (except to copanlisib) provided that there is no resistance.
Previous exposure to either fluorouracil (-FU) or capecitabine at a systemic dose except for use in concurrent chemoradiation
Prior exposure to cardiotoxic agent, such as anthracyclines, within months of enrollment
Exposure to any new immunosuppressive medication in the weeks prior to enrollment
Post-transplant exposure to any novel immunosuppressive medication (e.g., alemtuzumab) within days prior to enrollment
No prior exposure to immune-mediated therapy;
No prior exposure to immune-mediated therapy
Subjects with any prior exposure to a thrombopoietin-receptor agonist
Prior exposure to oprozomib
Prior exposure to plerixafor
Subject with a history of exposure to enzalutamide.
Any previous exposure to a CYP (?-hydroxylase/C,-lyase) inhibitor;
Prior exposure to selected immune cell-modulating antibody regimens
Subjects with any prior exposure to a thrombopoietin-receptor agonist
Prior exposure to systemic intravenously given doxorubicin
Prior oprozomib exposure
Prior therapy\r\n* Patients with prior exposure to brentuximab vedotin are not eligible; NOTE: prior exposure to gemcitabine is NOT an exclusion criterion\r\n* Patients who have undergone prior autologous or allogeneic SCT are not eligible\r\n* Patients with HL who were stage IA or IIA at initial diagnosis and treated with either radiation alone or < cycles of chemotherapy are not eligible
Inability to avoid exposure of skin or eyes to direct sunlight or bright indoor light for at least days
Have no prior exposure to cytochrome family (CYP-) (other than ketoconazole) or PARP inhibitors for prostate cancer; patients with prior exposure to ketoconazole are eligible
Prior exposure to agents targeting interleukin (IL ) or the IL receptor
Previous exposure to hepatitis A or B vaccines
History of prior Lupron intolerance; Note: patients ARE eligible if prior or current Lupron exposure
Prior exposure to radio- or toxin-immunoconjugates
Prior exposure to a selective inhibitors of nuclear export (SINE) compound
All subjects must be counseled about pregnancy precautions and risks of fetal exposure.
Exposure to household contacts =< months old or household contact with known immunodeficiency
Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Be counseled about pregnancy precautions and risks of fetal exposure
Patients with previous exposure to brentuximab pre-transplant are eligible for the study
Prior exposure to dasatinib (> days), Brutons tyrosine kinase inhibitor exposure, or prior chemotherapy for ALL (up to days of steroids are allowed)
Previous exposure to PNT.
Previous exposure to BTKi therapy and meets at least one of the below criteria:
Prior exposure to ibrutinib
Insufficient time from last prior regimen or radiation exposure (washout period of weeks)
Prior exposure to ibrutinib
History of exposure to pseudomonas exotoxin containing molecule
Prior exposure to NY-ESO- vaccine.
Prior exposure to pralatrexate.
Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone
Be counseled about pregnancy precautions and risks of fetal exposure. ARM B ONLY:
History of exposure to the following cumulative doses of anthracyclines:
Prior exposure to an investigational agent or device within days of signing the ICF. Of note, the subject may participate in observational studies;
Exposure to any systemic chemotherapy within days of date of randomization.
Prior epirubicin exposure of > mg/m.
Exposure to an investigational or marketed agent that can act by EGFR inhibition
Exposure to high dose Ara-C within months of enrollment.
Prior Exposure to Sotatercept (ACE-)
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Any prior exposure to gene vector delivery products
Patients with previous exposure to trabectedin
Part D: Prior exposure to BRAF inhibitors. A washout period of weeks is required for ipilimumab.
Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.
Patients with prior exposure to agents targeting interleukin (IL -) or the IL- receptor are not eligible
Prior exposure to radium-
Previous exposure to enzalutamide
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. Additional Exclusion Criteria for the SC- and ABBV- Combination Treatment Regimen:
The ability to administer protocol doses of TLI (i.e., , , , or cGy) without exceeding cumulative doses of radiation must be established; for patients with prior radiotherapy exposure, this determination will be made by Dr. Greven (or her designee) using published guidelines for excessive organ exposure; (in rare cases, this may apply to retreatment; if so, all of eligibility requirements must be met again)
Subjects who have had previous chemotherapy exposure
Prior exposure to neurotoxic chemotherapy
Exposure to any new immunosuppressive medication in the weeks prior to enrollment
Patients with > hours of direct exposure to outdoor natural light per day by interview with the Study Coordinator
Use of oral bisphosphonates with a cumulative exposure of more than year
Interested in reducing transfusion exposure
Prior exposure to sotatercept
Exposure to any new immunosuppressive medication in the weeks prior to enrollment
BREAST CANCER SURVIVORS: Has no prior exposure to neurotoxic chemotherapy or radiation treatment;
Individuals with a history of natural or artificial sun exposure to the buttocks within days of study participation are not eligible
Exposure to cisplatin treatment without intervention
Patients with steroid refractory cGVHD cannot have prior exposure to any new immunosuppressive medication in the preceding weeks prior to enrollment
Patient has had previous exposure to Folotyn within months of study enrollment
Prior exposure to veledimex
Subject has had previous radiation exposure of the involved breast
Prior exposure to veledimex
Exposure to any of the following:
Previous exposure to OTL
Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation
Prior exposure to neurotoxic chemotherapy
For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than months
Previous exposure to OTL
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Prior exposure to a SINE compound (i.e. an XPO- inhibitor), including selinexor.
No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
Prior exposure to CBT-
Cancer survivors who have previous exposure to medications or chemotherapy that cause neuropathy are excluded from this study
Prior exposure to cisplatin, -fluorouracil, tamoxifen, and/or MEK inhibitors within months of enrollment and/or ethambutol and/or hydroxychloroquine within months.
Prior exposure to idelalisib
Prior exposure to targeted SYK inhibitors.
Previous exposure to OTL