Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
Phase 1
Terminated
- Conditions
- Advanced Colorectal Cancer
- Interventions
- Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
- Registration Number
- NCT01271166
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
- ECOG 0 or 1
- Measurable disease
Exclusion Criteria
- Prior first line therapy for advanced disease
- Significant bulk of metastatic disease or rapid progression
- If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glivec®, modified FOLFOX, Avastin® Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab -
- Primary Outcome Measures
Name Time Method Tumour response as assessed by CT scan and RESIST 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novarts Investigative Site
🇦🇺Melbourne, Australia