An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols
2 other identifiers
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2010
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedStudy Start
First participant enrolled
August 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2019
CompletedResults Posted
Study results publicly available
February 17, 2021
CompletedMarch 10, 2021
February 1, 2021
8.4 years
July 21, 2010
January 28, 2021
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extent of Exposure to ARQ 197 in Participants Benefiting From Prior ARQ 197 Therapy
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 Outcomes (2)
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
Up to 3021 days
Number of Participants Discontinuing Treatment Due to an AE
Up to 3,021 days
Study Arms (1)
Tivantinib (Monotherapy or Combination Therapy)
EXPERIMENTALTivantinib 360 mg will be administered twice daily, orally, with meals, as a monotherapy or in combination with other drug therapies.
Interventions
Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2010
First Posted
August 10, 2010
Study Start
August 31, 2010
Primary Completion
January 14, 2019
Study Completion
January 14, 2019
Last Updated
March 10, 2021
Results First Posted
February 17, 2021
Record last verified: 2021-02