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CI 1033

Phase 2

Breast Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: May 4, 2007

CI 1033 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Dec 2002

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment370

FDA Designations

No designations recorded

CI 1033 clinical trials

CI 1033 · 3 trials · 3 indications

Phase 2 2Phase 1 1
NCT00050830A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung CancerLung Neoplasms
COMPLETED163 Analytics
NCT00051051A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast CancerBreast Neoplasms
COMPLETED168 Analytics
PHASE2COMPLETED
A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
Lung NeoplasmsUnlock trial analytics
PHASE2COMPLETED
A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy
The primary objective is to assess the antitumor activity of CI 1033 in patients with metastatic breast cancer.
The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6

Secondary Endpoints

Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations
Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])
correlations between erbB expression and efficacy
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CI 1033DRUG -
CI-1033DRUG -
PACLITAXELDRUG -
CARBOPLATINDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at l...

Countries:United StatesCanadaGermanyIrelandItalyNetherlandsSpainUnited KingdomBelgiumFranceSweden
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Frequently asked questions about CI 1033

What is CI 1033 used for?

CI 1033 is an investigational oral small molecule that was studied in oncology for metastatic breast cancer and advanced non-small cell lung cancer. It was evaluated as a single agent in Phase 2 studies and in combination with paclitaxel and carboplatin as first line chemotherapy in NSCLC patients.

Who makes CI 1033?

CI 1033 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program evaluating the compound in breast cancer and non-small cell lung cancer, including a Phase 2 monotherapy study and a Phase 1 combination study.

What phase is CI 1033 in?

CI 1033 reached Phase 2 clinical development. It is investigational and was studied in completed Phase 1 and Phase 2 trials; the program's registered studies are all listed as completed, with no active trials. The Phase 2 studies enrolled patients with metastatic breast cancer and advanced non-small cell lung cancer.

What clinical trials is CI 1033 in?

CI 1033 was studied in NCT00051051, a Phase 2 trial in metastatic Stage IV breast cancer that enrolled 168 patients across the United States and Europe, and NCT00050830, a randomized Phase 2 trial in advanced non-small cell lung cancer. A Phase 1 trial, NCT00174356, tested CI-1033 with paclitaxel and carboplatin in NSCLC.

Is CI 1033 the same as CI-1033?

Yes. CI 1033 and CI-1033 refer to the same investigational compound developed by Pfizer. The hyphenated form, CI-1033, appears in the registered clinical trial titles, including the Phase 2 breast cancer study and the Phase 2 non-small cell lung cancer study, while CI 1033 is the unhyphenated spelling of the same drug name.

How many patients were enrolled in CI 1033 trials?

The CI 1033 clinical program enrolled patients across three completed studies. The Phase 2 breast cancer trial enrolled 168 patients, the randomized Phase 2 non-small cell lung cancer trial enrolled 163 patients, and the Phase 1 combination trial with paclitaxel and carboplatin enrolled 39 patients with NSCLC.