A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer
- Conditions
- Pancreatic cancer10014713
- Registration Number
- NL-OMON33926
- Lead Sponsor
- PRA International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection; Adequate coagulation, hepatic and renal function documented within 14 days prior to treatment; Adequate bone marrow function; Male or female, age 18 years or older; ECOG performance status of 0 or 1; Life expectancy of *12 weeks; Resolution of all acute toxic effects of prior therapies, or surgical procedure to NCI CTCAE Grade < or equal to 1; No evidence of preexisting uncontrolled hypertension; negative pregnancy test; Signed and dated informed consent. See also protocol page 27
Prior treatment with any systemic chemotherapy for metastatic disease; Prior adjuvant chemotherapy or radiotherapy <4 weeks before starting study treatment; Prior treatment with gemcitabine, AG-013736 or other VEGF inhibitors; Gastrointestinal abnormalities; central lung lesions involving major blood vessels; history of hemoptysis; current or recent use of a thrombolytic agent; Current use or anticipated use for treatment with potent CYP3A4 inhibitors/CYP1A2 or CYP3A4 inducers; active seizure disorder; serious uncontrolled medical disorder or active infection; Dementia or significantly altered mental status; Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness; pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective: Compare the overall survival (OS) of patients receiving<br /><br>gemcitabine plus AG-013736 versus gemcitabine plus placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives: 1. Compare the progression free survival (PFS) of<br /><br>patients in each arm;2. Compare the objective response rate (ORR) of patients<br /><br>in each arm;3. Estimate the duration of response (DR) of patients in each arm;<br /><br>4. Evaluate the safety and tolerability of AG-013736 plus gemcitabine;<br /><br>5.Compare the health-related quality of life (HRQOL), pain ratings, and health<br /><br>status of patients in each arm; 6. Conduct population pharmacokinetic analysis<br /><br>using AG-013736 plasma concentrations.<br /><br></p><br>