| October 8, 2004 |
| October 3, 2009 |
| September 2004 |
| December 2010 (final data collection date for primary outcome measure) |
| Safety [ Time Frame: 5 years ] [ Designated as safety issue: No ] |
| Safety and access to drug for patients who otherwise would not have access |
| Complete list of historical versions of study NCT00094029 on ClinicalTrials.gov Archive Site |
- Time to Tumor Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|
| OS, TTP, ORR |
| |
| A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248 |
| A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate |
The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248. |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Gastrointestinal Neoplasm |
| Drug: SU011248 |
| Experimental: sutent, 25, 37.5, or 50 mg daily |
| |
| |
| Recruiting |
| 1400 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
- Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
- Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
- Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
- Male or Female, 18 years or older
- Resolution of all acute toxicities of prior therapies
- Adequate organ function
Exclusion Criteria:
- Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
- Symptomatic central nervous system metastases
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding.
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela |
| |
| NCT00094029 |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| A6181036 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| October 2009 |
