A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
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ClinicalTrials.gov Identifier: NCT00075218 |
Recruitment Status :
Completed
First Posted : January 8, 2004
Results First Posted : September 28, 2009
Last Update Posted : September 28, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Stromal Tumor | Drug: Placebo Drug: SU011248 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 361 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor |
Study Start Date : | December 2003 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: B |
Drug: Placebo
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug. |
Active Comparator: A |
Drug: SU011248
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug. |
- Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase ]Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
- Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study [ Time Frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) ]Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
- Progression Free Survival (PFS) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).
- Overall Survival Status of Subjects [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]Number of subjects alive at end of study.
- Overall Survival [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]Time from date of randomization to date of death due to any cause.
- Overall Survival Based on the Rank Preserving Structural Failure Time Method [ Time Frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug ]time from date of randomization to date of death due to any cause (rank preserving structural failure time method).
- Best Overall Tumor Response During Double-blind Treatment Phase [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Confirmed Objective Response (CR or PR) in Subjects [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.
- Time to Tumor Response (TTR) [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.
- Duration of Performance Status Maintenance [ Time Frame: Day 28 of each cycle : duration of double-blind treatment phase ]Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.
- Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)
- Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.
- Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS) [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.
- Change From Baseline in EQ-5D Health State Profile Index [ Time Frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase ]Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
- Failed Gleevec treatment or intolerant to Gleevec therapy
Key Exclusion Criteria:
- Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075218
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
ClinicalTrials.gov Identifier: | NCT00075218 |
Obsolete Identifiers: | NCT00085618 |
Other Study ID Numbers: |
A6181004 |
First Posted: | January 8, 2004 Key Record Dates |
Results First Posted: | September 28, 2009 |
Last Update Posted: | September 28, 2009 |
Last Verified: | August 2009 |
Gastrointestinal Stromal Tumors Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Sunitinib |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |