ARQ 197 in Subjects With Metastatic Solid Tumors - Full Text View

Sponsored by:	ArQule
Information provided by:	ArQule
ClinicalTrials.gov Identifier:	NCT00302172

Purpose

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Condition	Intervention	Phase
Cancer Tumor	Drug: ARQ 197	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by ArQule:

Primary Outcome Measures:

safety, tolerability [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the pharmacokinetic profile of ARQ 197. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met ] [ Designated as safety issue: No ]
To determine the pharmacodynamics (i.e., identify biomarkers) of ARQ 197. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met ] [ Designated as safety issue: No ]
To assess the preliminary anti-tumor activity of ARQ 197. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met ] [ Designated as safety issue: No ]

Estimated Enrollment:	78
Study Start Date:	January 2006

Arms	Assigned Interventions
ARQ 197: Experimental	Drug: ARQ 197 Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days). Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks. All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted.

Arms

Assigned Interventions

ARQ 197: Experimental

Drug: ARQ 197

Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts.

Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days). Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks. All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted.

Detailed Description:

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed written informed consent must be obtained and documented according to ICH GCP, the local regulatory requirements, and permission to use private health information in accordance with HIPPA prior to study-specific screening procedures
A histologically or cytologically confirmed RCC or other c-Met expression tumors that is metastatic
Patient must have available archival tumor tissue or accessible tumor that is safely amenable to tumor biopsy
≥ 18 years of age
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
Karnofsky performance status ≥ 70%
Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
Females of childbearing potential must have a negative serum pregnancy test
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN with metastatic liver disease.
Hemoglobin (Hgb) ≥ 10 g/dl
Total bilirubin ≤ 1.5 × ULN
Creatinine ≤ 1.5 x ULN
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelets ≥ 100 x 10^9/L

Exclusion Criteria:

Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose
Surgery within 4 weeks prior to first dose
Known brain metastases
Pregnant or breastfeeding
Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
Unable or unwilling to swallow ARQ 197 capsules twice daily
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
Bradycardia at baseline or known history of arrhythmia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302172

Locations

United States, California
Premiere Oncology
Santa Monica, California, United States, 90404
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246

Sponsors and Collaborators

ArQule

More Information

No publications provided

Responsible Party:	ArQule, Inc. ( ArQule )
Study ID Numbers:	ARQ 197-101
Study First Received:	March 10, 2006
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00302172 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ArQule:

Cancer
solid tumor
metastatic
primary tumor

ClinicalTrials.gov processed this record on September 02, 2009