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

Phase 1/Phase 2
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

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

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 continue to 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

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

Inclusion Criteria:

- Signed written informed consent to Study ARQ 197-299

- Male or female subjects of the age defined in the original protocol they were

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3

- Adequate bone marrow function:

- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L

- Hemoglobin ≥8.0 g/dL

- Enrollment within 14 days of the completion of End of Study Visit of the original

- 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

- 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 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

- in the opinion of the Investigator, the subject does not have progressive

- the radiation field does not encompass a target lesion

- no more than 10% of the subject's bone marrow is irradiated

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To provide ongoing treatment with ARQ 197 for patients who have benefited from prior treatment with ARQ 197

Outcome Time Frame:

No time frame

Safety Issue:



United States: Food and Drug Administration

Study ID:

ARQ 197-299



Start Date:

August 2010

Completion Date:

June 2014

Related Keywords:

  • Advanced Solid Tumors
  • hepatocellular carcinoma
  • renal cell carcinoma
  • melanoma
  • non-small cell lung cancer
  • breast cancer
  • ovarian cancer
  • MiT tumors



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