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CT-011

Phase 2

Melanoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jan 20, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

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Clinical trial landscape

CT-011 · 2 trials · 3 indications

Phase 2 2
NCT01435369Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic MelanomaMelanoma
COMPLETED103 Analytics
NCT00890305Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX AloneMetastatic Colorectal Cancer
COMPLETED171 Analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy Study of the Monoclonal Antibody, CT-011, in Patients With Metastatic Melanoma
MelanomaUnlock trial analytics
PHASE2COMPLETED
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Metastatic Colorectal CancerUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
CT-011DRUGThe monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months.
FOLFOXDRUGFOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days. mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours).
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Frequently asked questions about CT-011

What is CT-011 used for?

CT-011 is an investigational small molecule being studied for the treatment of metastatic colorectal cancer and melanoma. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes CT-011?

CT-011 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.

What phase is CT-011 in?

CT-011 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in metastatic colorectal cancer and one in melanoma. The drug remains investigational and is not FDA approved.

What clinical trials is CT-011 in?

CT-011 has been studied in two completed Phase 2 trials. NCT00890305 evaluated FOLFOX plus CT-011 versus FOLFOX alone in 171 patients with metastatic colorectal cancer. NCT01435369 evaluated CT-011 in 103 patients with metastatic melanoma.

Is CT-011 a targeted therapy?

CT-011 is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. It is being studied in unselected patient populations without biomarker screening.