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

February 17, 2021 updated by: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Tivantinib
Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.
Other Names:
  • ARQ 197
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.
Other Names:
  • ARQ 197

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of Exposure to ARQ 197 in Participants Benefiting From Prior ARQ 197 Therapy
Time Frame: Up to 3,021 days (up to 14-Jan-2019)
The duration of ARQ 197 exposure in this study was calculated as [(date of last dose of study drug - date of first dose of study drug) + 1]. Results refer to duration of ARQ 197 treatment in the present study only (i.e., does not include treatment received during participation in "feeder" studies).
Up to 3,021 days (up to 14-Jan-2019)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
Time Frame: Up to 3021 days
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Up to 3021 days
Number of Participants Discontinuing Treatment Due to an AE
Time Frame: Up to 3,021 days
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Up to 3,021 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2010

Primary Completion (ACTUAL)

January 14, 2019

Study Completion (ACTUAL)

January 14, 2019

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (ESTIMATE)

August 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARQ 197-299
  • 2010-020151-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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