Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors
NCT00511849
Last updated date
ABOUT THIS STUDY
The purpose of this study is to test SU011248 (sunitinib) in combination with
paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor
activity.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent
- Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens
- ECOG performance status 0 or 1
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry
except palliative radiotherapy to non-target, metastatic lesions
- Diagnosis of any second malignancy within the past 3 years
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
NeoplasmsPharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies
NCT00859118
- Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
NeoplasmsSafety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
NCT00095160
- Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
NeoplasmsBiodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen
NCT00293215
- Herston, Queensland
- Heidelberg (Melbourne), Victoria
ALL GENDERS
18 Years+
years
MULTIPLE SITES
NeoplasmsStudy To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors
NCT00225121
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Santa Monica, California
- Santa Monica, California
- Aurora, Colorado
- Boston, Massachusetts
- Boston, Massachusetts
- Amsterdam,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors | |||
| Official Title ICMJE | Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies | |||
| Brief Summary | The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Neoplasms | |||
| Intervention ICMJE | Drug: carboplatin + SU011248 (sunitinib) + paclitaxel
AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity. Other Name: Paraplatin; SUTENT; Taxol | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Drug: carboplatin + SU011248 (sunitinib) + paclitaxel | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 43 | |||
| Original Enrollment ICMJE | 50 | |||
| Actual Study Completion Date ICMJE | February 2009 | |||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00511849 | |||
| Other Study ID Numbers ICMJE | A6181050 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||