Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer | NCT01271166

Studies
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer

NCT01271166

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Jan 6, 2011Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Advanced Colorectal Cancer

Interventions

Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Not provided

First Submitted Date

Jan 4, 2011

First Submission Date that Met QC Criteria

Jan 5, 2011

First Posted Date

Jan 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2011

Last Update Posted Date

Jan 6, 2011Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glivec®, modified FOLFOX, Avastin®	Experimental		Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab	Drug		Glivec®, modified FOLFOX, Avastin®

Measure	Description	Time Frame
Tumour response as assessed by CT scan and RESIST		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novarts Investigative Site		Melbourne			Australia

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate
D005472	Fluorouracil
D000077150	Oxaliplatin
D002955	Leucovorin
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided