An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: Tivantinib

Drug: Anti-Cancer Combination Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01178411

ARQ 197-299

2010-020151-31 (EudraCT Number)

Details and patient eligibility

About

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 extension study is designed to further evaluate the safety and tolerability of tivantinib (ARQ 197) monotherapy or in combination with other drug(s) when given to participants who tolerated previous treatment well and may benefit from the continuing treatment.

Full 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, NCT00557609, NCT00988741, NCT01395758 , and NCT01055067) tivantinib studies that have reached their designated end-dates. Participants enrolled in this extension protocol will provide further safety and tolerability information about tivantinib monotherapy or in combination with other drug(s) at the same dose(s), and same schedule(s) in which they were originally enrolled.

Enrollment

60 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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