Clinical trial · Interventional

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

NCT01178411CI-TRIAL-00050583completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Anti-Cancer Combination Therapy	Drug	—	UNRESOLVED
Tivantinib	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Tivantinib (Monotherapy or Combination Therapy)
description
Tivantinib 360 mg will be administered twice daily, orally, with meals, as a monotherapy or in combination with other drug therapies.
interventionNames
1. Drug: Tivantinib
2. Drug: Anti-Cancer Combination Therapy

Primary outcomes (1)

measure
Extent of Exposure to ARQ 197 in Participants Benefiting From Prior ARQ 197 Therapy
timeFrame
Up to 3,021 days (up to 14-Jan-2019)
description
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).

Secondary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 13 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.