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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT01178411
First received: July 21, 2010
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: ARQ 197 as monotherapy or in combination with other drug(s)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols

Resource links provided by NLM:


Further study details as provided by ArQule:

Primary Outcome Measures:
  • To provide ongoing treatment with ARQ 197 for patients who have benefited from prior treatment with ARQ 197 [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To collect additional safety and tolerability for ARQ 197 treatment [ Time Frame: No time frame ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197 as monotherapy or in combination with other drug (s)
ARQ 197 will be administered twice daily, orally, with meals
Drug: ARQ 197 as monotherapy or in combination with other drug(s)
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.

Detailed Description:

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178411

Locations
United States, California
Los Angeles, California, United States, 90033
Santa Monica, California, United States, 90404
United States, Connecticut
Torrington, Connecticut, United States, 06790
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30341
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Tennessee
Nashville, Tennessee, United States, 37203
Nashville, Tennessee, United States, 37212
United States, Texas
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Germany
Munich, Germany, 82131
Italy
Milan, Italy, 20089
Russian Federation
Moscow, Russian Federation, 123367
St. Petersburg, Russian Federation, 197089
Sponsors and Collaborators
ArQule
  More Information

No publications provided

Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT01178411     History of Changes
Other Study ID Numbers: ARQ 197-299
Study First Received: July 21, 2010
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation

Keywords provided by ArQule:
hepatocellular carcinoma
renal cell carcinoma
melanoma
non-small cell lung cancer
breast cancer
ovarian cancer
MiT tumors

ClinicalTrials.gov processed this record on August 01, 2014