NCT00113529

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 31, 2010

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

2.9 years

First QC Date

June 8, 2005

Results QC Date

March 1, 2010

Last Update Submit

August 25, 2011

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

    From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter

Secondary Outcomes (29)

  • Time to Tumor Response (TTR)

    From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter

  • Duration of Response (DR)

    From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer

  • Time to Tumor Progression (TTP)

    From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter

  • Overall Survival (OS)

    From start of study treatment until death

  • Progression-Free Survival (PFS)

    From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death

  • +24 more secondary outcomes

Study Arms (1)

Sunitinib + Gefitinib

EXPERIMENTAL

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

Drug: Gefitinib + Sunitinib

Interventions

Gefitinib + SunitinibDRUG

Until disease progression or unacceptable toxicity.

Also known as: Iressa, SU011248, SUTENT
Sunitinib + Gefitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (1)

  • 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.

    PMID: 20142724DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

GefitinibSunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrrolesAzolesHeterocyclic Compounds, 1-RingIndoles

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2005

First Posted

June 9, 2005

Study Start

October 1, 2004

Primary Completion

September 1, 2007

Study Completion

October 1, 2008

Last Updated

August 29, 2011

Results First Posted

March 31, 2010

Record last verified: 2011-08

Locations

US(3)