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CT-322

Phase 2

Colorectal Cancer (CRC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

CT-322 development status

Highest phase Phase 2
Registered trials 5 across 2 sponsors since Sep 2006

CT-322 target and mechanism

ModalitySmall molecule

Also known as BMS-844203

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment57

FDA Designations

No designations recorded

CT-322 clinical trials

CT-322 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00851045Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal CancerColorectal Cancer (CRC)
COMPLETED17 Analytics
PHASE2COMPLETED
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
Colorectal Cancer (CRC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival based on tumor assessments (CT/MRI)
Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent
Safety and tolerability of CT-322
Throughout the study

Secondary Endpoints

Overall survival (OS), defined as the time the subject is randomized until death, in each arm
every 12 weeks
Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator
every 6 weeks
Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects
weekly
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATORIrinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
Arm 2ACTIVE_COMPARATORIrinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)

Interventions

NameTypeDescription
IrinotecanDRUGSolution, IV, 180 mg/m2, Q14 days, Until PD
5-Fluorouracil (bolus)DRUGSolution, IV, 400 mg/m2, Q14 days, Until PD
5-Fluorouracil (infusional)DRUGSolution, IV, 2400 mg/m2, Q14 days, Until PD
Leucovorin calciumDRUGSolution, IV, 400 mg/m2, Q14 days, Until PD
CT-322DRUGSolution, IV, 2 mg/kg, Q7 days, Until PD
BevacizumabDRUGSolutions, IV, 5 mg/kg, Q14 days, Until PD
Bevacizumab Placebo (saline solution)DRUGSolution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * ECOG Performance Status (PS) ≤1 * Histologically or cytologically confirmed, unresectable metastatic colorectal cancer * Measurable disease by RECIST guidelines * Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab...

Countries:United StatesArgentinaItaly
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Competitive Landscape -Colorectal Cancer 361 trials (matched to "Colorectal Cancer (CRC)")

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Frequently asked questions about CT-322

What is CT-322 used for?

CT-322 is an investigational oncology drug studied in cancer, including advanced solid tumors, non-Hodgkin's lymphoma, and metastatic colorectal cancer. It was evaluated as a single agent and in combination with chemotherapy for second-line treatment of metastatic colorectal cancer. It is not an approved therapy.

Who is developing CT-322?

CT-322 was developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical research program for the drug in oncology indications.

What phase is CT-322 in?

CT-322 is in Phase 1 development. It is an investigational agent and has not been approved for any indication. A Phase 1 study in advanced solid tumors and non-Hodgkin's lymphoma has been completed, and a Phase 2 study in metastatic colorectal cancer has also been completed.

What clinical trials is CT-322 in?

CT-322 has been studied in two completed trials. NCT00374179 was a Phase 1 trial in advanced solid tumors and non-Hodgkin's lymphoma with 40 patients. NCT00851045 was a Phase 2 trial combining CT-322 with chemotherapy for second-line metastatic colorectal cancer with 17 patients.

Is CT-322 FDA approved?

No. CT-322 is an investigational drug and is not FDA approved. It remains in clinical development, with completed Phase 1 and Phase 2 trials in cancer and metastatic colorectal cancer.