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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ann Arbor, Michigan, 48109 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00113529
Pfizer
Completed
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

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Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
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).
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: Gefitinib + Sunitinib
Until disease progression or unacceptable toxicity.
Other Name: Iressa, SU011248, SUTENT
Experimental: 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

Intervention: Drug: Gefitinib + Sunitinib
Motzer RJ, Hudes GR, Ginsberg MS, Baum MS, Harmon CS, Kim ST, Chen I, Redman BG. Phase I/II trial of sunitinib plus gefitinib in patients with metastatic renal cell carcinoma. Am J Clin Oncol. 2010 Dec;33(6):614-8. doi: 10.1097/COC.0b013e3181c4454d.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2008
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00113529
A6181038
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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