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

NCT ID: NCT01178411

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2019-01-14

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 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.

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, 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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tivantinib (Monotherapy or Combination Therapy)

Tivantinib 360 mg will be administered twice daily, orally, with meals, as a monotherapy or in combination with other drug therapies.

Group Type: EXPERIMENTAL

Tivantinib

Intervention Type: DRUG

Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.

Anti-Cancer Combination Therapy

Intervention Type: DRUG

Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the same dose and schedule in which they were administered in the original (previous) study.

Interventions

Tivantinib

Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.

Intervention Type: DRUG

Anti-Cancer Combination Therapy

Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the same dose and schedule in which they were administered in the original (previous) study.

Intervention Type: DRUG

Other Intervention Names

ARQ 197; ARQ 197

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2010-020151-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARQ 197-299

Identifier Type: -

Identifier Source: org_study_id