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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:1/18/2019
Start Date:August 2010
End Date:April 2019

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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.

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).

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
enrolled.

- 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 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

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 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
We found this trial at
13
sites
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San Antonio, TX
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Atlanta, GA
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Boston, MA
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Dallas, TX
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Durham, NC
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Houston, TX
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Miami, FL
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Munich,
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Nashville, TN
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Nashville, TN
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Santa Monica, CA
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Torrington, CT
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