A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00615446
First received: February 1, 2008
Last updated: April 29, 2010
Last verified: April 2010
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Purpose
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: SU011248; Gemcitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ] [ Designated as safety issue: No ]
- To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | March 2005 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: SU011248; Gemcitabine
Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
Other Name: Sutent, sunitinib, SU11248, Gemzar
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
- Patient has good performance status (ECOG 0 or 1)
Exclusion Criteria:
- Prior treatment with either gemcitabine or SU011248
- Hypertension that cannot be controlled by medications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615446
Locations
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02114 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc. |
| ClinicalTrials.gov Identifier: | NCT00615446 History of Changes |
| Other Study ID Numbers: | A6181041 |
| Study First Received: | February 1, 2008 |
| Last Updated: | April 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
solid tumor malignancy, SU011248, sunitinib, neoplasms |
Additional relevant MeSH terms:
|
Neoplasms Gemcitabine Sunitinib Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents |
Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013