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A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00034827
Collaborator
(none)
172
Enrollment
30
Locations
15.9
Duration (Months)
5.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer, or Pancreatic Cancer
Study Start Date :
Jan 1, 2002
Actual Study Completion Date :
May 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Overall objective response and clinical benefit response []

Secondary Outcome Measures

  1. Time to objective response, duration of response, time to progression and survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer.

  • No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer.

  • Original or recent tumor tissue must be available.

  • Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks.

  • Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor).

  • Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug.

Exclusion Criteria:

  • Unstable medical condition

  • prior chemotherapy within 4 week of screening

  • series infection

  • other tumor types

  • ECOG performance status of 3 or 4.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States 35205
2 Pfizer Investigational Site Birmingham Alabama United States 35233
3 Pfizer Investigational Site Blendora California United States 91740
4 Pfizer Investigational Site Glendale California United States 91204
5 Pfizer Investigational Site Huntington Beach California United States 92648
6 Pfizer Investigational Site Long Beach California United States 90813
7 Pfizer Investigational Site Los Alamitos California United States 90720
8 Pfizer Investigational Site Los Angeles California United States 90048
9 Pfizer Investigational Site Los Angeles California United States 90095
10 Pfizer Investigational Site Mission Hills California United States 91345
11 Pfizer Investigational Site Northridge California United States 91328
12 Pfizer Investigational Site Oxnard California United States 93030
13 Pfizer Investigational Site Pasadena California United States 91105
14 Pfizer Investigational Site Pomona California United States 91767
15 Pfizer Investigational Site Rancho Cucamonga California United States 91730
16 Pfizer Investigational Site Redondo Beach California United States 90277
17 Pfizer Investigational Site Santa Monica California United States 90404
18 Pfizer Investigational Site Torrance California United States 90505
19 Pfizer Investigational Site Ventura California United States 93003
20 Pfizer Investigational Site West Covina California United States 91790
21 Pfizer Investigational Site Atlanta Georgia United States 30342
22 Pfizer Investigational Site Decatur Georgia United States 30033
23 Pfizer Investigational Site Macon Georgia United States 30342
24 Pfizer Investigational Site Crestview Hills Kentucky United States 41017
25 Pfizer Investigational Site Detroit Michigan United States 48201
26 Pfizer Investigational Site Rochester Minnesota United States 55905
27 Pfizer Investigational Site Cincinnait Ohio United States 45236
28 Pfizer Investigational Site Cincinnati Ohio United States 45219
29 Pfizer Investigational Site Cincinnati Ohio United States 45230
30 Pfizer Investigational Site Cincinnati Ohio United States 45242

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00034827
Other Study ID Numbers:
  • 1040-000-002
First Posted:
May 3, 2002
Last Update Posted:
May 4, 2007
Last Verified:
Jul 1, 2006
Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms

Study Results

No Results Posted as of May 4, 2007