Summary

at UCLA
study started
estimated completion

Description

Summary

This is an extension study that will allow patients to continue to receive study treatment when the original studies into which they were enrolled have reached their designated end-dates.

Details

This is an open label extension protocol for patients who have been treated in previous ARQ 197 studies that have reached their designated end-dates. Patients enrolled in this extension protocol will receive either ARQ 197 as monotherapy or in combination with other drug(s) at the same dose(s), and same schedule(s) in which they were originally enrolled.

This extension study is designed to further evaluate the safety and tolerability of ARQ 197 monotherapy or in combination with other drug(s) when given to patients who tolerated previous treatment well and may benefit from the continuing treatment. ARQ 197 will be administered twice daily, orally, with meals (regardless of the original protocol requirements).

Keywords

Advanced Solid Tumors hepatocellular carcinoma renal cell carcinoma melanoma non-small cell lung cancer breast cancer ovarian cancer MiT tumors ARQ 197 as monotherapy or in combination with other drug(s)

Eligibility

You can join if…

  • Signed written informed consent to Study ARQ 197-299
  • Male or female subjects of the age defined in the original protocol they were enrolled.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L

  • Hemoglobin ≥8.0 g/dL
  • Enrollment within 14 days of the completion of End of Treatment Visit of the original study
  • Subjects, 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 CAN'T join if...

  • Known or suspected allergy to ARQ 197
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Any condition that is unstable or which could jeopardize the safety of the subject 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 subject 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 subject does not have progressive disease
  • the radiation field does not encompass a target lesion
  • no more than 10% of the subject's bone marrow is irradiated

Locations

  • Santa Monica California 90404 United States
  • Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ArQule
ID
NCT01178411
Phase
Phase 1/2
Study Type
Interventional
Last Updated