A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-11-30

Brief Summary

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This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.

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Detailed Description

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Conditions

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Neoplasm, Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CDD

Group Type EXPERIMENTAL

Sunitinib, Pemetrexed

Intervention Type DRUG

Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity.

2/1

Group Type EXPERIMENTAL

Sunitinib, Pemetrexed

Intervention Type DRUG

Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Interventions

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Sunitinib, Pemetrexed

Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Intervention Type DRUG

Sunitinib, Pemetrexed

Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Intervention Type DRUG

Other Intervention Names

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Sutent, SU011248, Alimta Sutent, SU011248, Alimta

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of a solid malignancy that is refractory to standard therapy or for which no standard therapy exists.
* Patients has a good performance status (ECOG 0 or 1)

Exclusion Criteria

* Prior treatment with either pemetrexed or SU011248.
* Coughing up blood within 4 weeks before starting study treatment (small amounts okey).
* Hypertension that cannot be controlled by medications.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No