An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols - Full Text View

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:	June 2014
Estimated Primary Completion Date:	June 2014 (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 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 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 Study 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

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

Contacts

Contact: ArQule, Inc.

800-373-7827

Locations

United States, California
	Recruiting
Los Angeles, California, United States, 90033
	Recruiting
Santa Monica, California, United States, 90404
United States, Connecticut
	Completed
Torrington, Connecticut, United States, 06790
United States, Florida
	Recruiting
Miami, Florida, United States, 33136
United States, Georgia
	Completed
Atlanta, Georgia, United States, 30341
United States, North Carolina
	Completed
Durham, North Carolina, United States, 27705
United States, Tennessee
	Completed
Nashville, Tennessee, United States, 37203
	Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
	Completed
Houston, Texas, United States, 77030
	Recruiting
San Antonio, Texas, United States, 78229
Germany
	Completed
Munich, Germany, 82131
Italy
	Completed
Milan, Italy, 20089
Russian Federation
	Recruiting
Moscow, Russian Federation, 123367
	Completed
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:	February 22, 2013
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 May 23, 2013