Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: carboplatin + SU011248 (sunitinib) + paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511849

A6181050

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

1

Experimental group

Treatment:

Drug: carboplatin + SU011248 (sunitinib) + paclitaxel