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Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies


Inclusion Criteria:



- Patients with a diagnosis of a solid cancer which is not responsive to standard
therapy or for which no standard therapy exists.

- Patient 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
okay).

- Hypertension that cannot be controlled by medications.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.

Outcome Time Frame:

From screening until at least 28 days beyond discontinuation of study treatment

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181084

NCT ID:

NCT00528619

Start Date:

November 2006

Completion Date:

April 2010

Related Keywords:

  • Neoplasms
  • Solid tumor malignancy
  • non-small cell lung cancer
  • sunitinib
  • pemetrexed
  • Phase 1
  • Mesothelioma
  • Neoplasms

Name

Location

Pfizer Investigational SiteAurora, Colorado  80012