Status:
COMPLETED
Dose Escalation Study of ARQ 197 in Combination With Gemcitabine in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, dose-escalation/de-escalation study of ARQ 197 administered orally in combination with gemcitabine. The study is designed to determine the safety, tolerability and maximum toler...
Detailed Description
Enrollment of an initial cohort of 3 or 6 patients will follow the traditional "3 + 3" dose escalation scheme. These patients will be treated with ARQ 197 and gemcitabine. ARQ 197 will be administered...
Eligibility Criteria
Inclusion
- Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- 18 year of age or older
- Histologically or cytologically confirmed locally advanced, inoperable or metastatic primary solid tumors
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN with metastatic liver disease
- Hemoglobin ≥ 10 g/dl (or ≥ 9 g/dl for expanded cohort)
- Total bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug
- Male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
Exclusion
- Other cancer within the last three years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
- Previous anti-cancer chemotherapy, radiotherapy, major surgery, immunotherapy or investigational agents within 4 weeks prior to the first day of study defined treatment
- History of cardiac disease: congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); previously diagnosed bradycardia or other cardiac arrhythmia defined as ≥ Grade 2 according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (version 3.0), or uncontrolled hypertension; myocardial infarction occurred within 6 months prior to study entry (myocardial infarction occurred \> 6 months prior to study entry is permitted)
- Active clinically serious infections defined as ≥ Grade 2 according to NCI CTCAE, version 3.0
- Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance
- Known human immunodeficiency virus (HIV) infection
- Pregnancy or breast-feeding
- Inability to swallow oral medications
- Significant gastrointestinal disorder, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or gemcitabine (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)
- Central nervous system metastases
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00874042
Start Date
March 1 2009
End Date
April 1 2011
Last Update
July 23 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta, Georgia, United States, 30341
2
Oklahoma City, Oklahoma, United States, 73104
3
Nashville, Tennessee, United States, 37203
4
Houston, Texas, United States, 77024