An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols - N/A

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 12.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB; MedDRA version: 12.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV

• Registration Number: EUCTR2010-020151-31-DE
• Lead Sponsor: ArQule, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-10
• Study Completion: 2019-01-14
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified