Non-Small Cell Lung Cancer MedDRA version: 12.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB MedDRA version: 12.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Product Name: ARQ 197
Product Code: ARQ 197
Pharmaceutical Form: Capsule*
INN or Proposed INN: (-)-trans-3-(5,6-dihydro-4H-pyrrolo[3,2,1-ij] quinolin-1yl)-4(1H-indo-3-yl)pyrrolidine-2, 5-dione
Current
Sponsors
ArQule, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent to Study ARQ 197-299 2. Male or female subjects of the age defined in the original protocol they were enrolled. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =3 4. Adequate bone marrow function: - Absolute neutrophil count (ANC) =1.5 x 10 to the 9th/L - Hemoglobin =8.0 g/dL 5. Enrollment within 14 days of the completion of End of Study Visit of the original study 6. Subjects, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment 7. Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to ARQ 197 2. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results 3. Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study 4. A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy 5. Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that: - in the opinion of the Investigator, the subject does not have progressive disease - the radiation field does not encompass a target lesion - no more than 10% of the subject’s bone marrow is irradiated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this extension protocol is to provide subjects who participated in previous ARQ 197 studies that have reached their designated end-dates with uninterrupted access to ARQ 197 if, in the opinion of the Investigator and the Sponsor, they may benefit from the treatment.;Secondary Objective: The secondary objective of this study is to collect additional safety, tolerability and efficacy information for ARQ 197 treatment.;Primary end point(s): This open label extension protocol will provide subjects who participated in previous ARQ197 studies that have reached their designed end-dates and who may have benefited from the treatment with uninterrupted access to the study drug. | — |
Countries
Germany, Italy, Latvia
Outcome results
None listed