Status:
COMPLETED
An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
13+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an extension study that will allow participants to continue to receive study therapy when the original studies into which they were enrolled have reached their designated end-dates. This exten...
Detailed Description
This open label extension protocol enrolls participants who were treated in previous phase 1 (NCT01149720, NCT01517399, NCT01699061, NCT00612703, NCT00827177, and NCT00874042) and phase 2 (NCT00777309...
Eligibility Criteria
Inclusion
- Signed written informed consent to participate in clinical study of tivantinib
- Male or female participants of the age defined in the original protocol they were enrolled.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3 (or ≤2 for tivantinib-naive participants)
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
- Hemoglobin ≥8.0 g/dL (or ≥ 9.0 g/dL for tivantinib-naïve participants)
- Enrollment within 14 days of the completion of End of Treatment Visit of the original study
- Participants, 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
- 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
Exclusion
- Known or suspected allergy to ARQ 197
- Substance abuse, medical, psychological or social conditions that may interfere with the participant's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the participant and his/her compliance in the study
- A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the participant to receive protocol therapy
- 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 participant does not have progressive disease
- the radiation field does not encompass a target lesion
- no more than 10% of the participant's bone marrow is irradiated
Key Trial Info
Start Date :
August 31 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01178411
Start Date
August 31 2010
End Date
January 14 2019
Last Update
March 10 2021
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