Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-10-31

Brief Summary

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To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).

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Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib + Gefitinib

Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib

Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib

Group Type EXPERIMENTAL

Gefitinib + Sunitinib

Intervention Type DRUG

Until disease progression or unacceptable toxicity.

Interventions

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Gefitinib + Sunitinib

Until disease progression or unacceptable toxicity.

Intervention Type DRUG

Other Intervention Names

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Iressa, SU011248, SUTENT

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed renal cell carcinoma with metastases
* Evidence of unidimensionally measurable disease
* Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

Exclusion Criteria

* RCC without any clear (conventional) cell component
* History of or known brain metastases
* Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No