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CI 1033

Phase 2

Lung Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 8, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment163

FDA Designations

No designations recorded

Clinical trial landscape

CI 1033 · 2 trials · 2 indications

Phase 2 1Phase 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
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

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 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
To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
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 Kingdom
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Frequently asked questions about CI 1033

What is CI 1033 used for?

CI 1033 is an investigational small molecule being studied for the treatment of lung neoplasms, breast neoplasms, and non-small cell lung carcinoma. It has been evaluated in clinical trials for advanced non-small cell lung cancer, metastatic breast cancer, and as a first-line chemotherapy combination in non-small cell lung cancer patients.

Who makes CI 1033?

CI 1033 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is an investigational small molecule in the oncology therapeutic area, and it has been studied in clinical trials for various cancer indications.

What phase is CI 1033 in?

CI 1033 is in Phase 1 clinical development. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is CI 1033 in?

CI 1033 has been studied in three completed clinical trials: NCT00050830, a Phase 2 study in advanced non-small cell lung cancer; NCT00051051, a Phase 2 study in metastatic breast cancer; and NCT00174356, a Phase 1 study combining CI 1033 with paclitaxel and carboplatin in non-small cell lung cancer.

Is CI 1033 the same as CI-1033?

Yes, CI 1033 and CI-1033 refer to the same drug. The name appears in clinical trial records with and without a hyphen, but both refer to the investigational small molecule being developed by Pfizer for the treatment of lung and breast cancers.