Clinical trial · Interventional
Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer
A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer
NCT00851045CI-TRIAL-00019436completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil (bolus) | Drug | Fluorouracil | ALIAS |
| 5-Fluorouracil (infusional) | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Bevacizumab Placebo (saline solution) | Drug | — | UNRESOLVED |
| CT-322 | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322
- interventionNames
- Drug: Irinotecan
- Drug: 5-Fluorouracil (bolus)
- Drug: 5-Fluorouracil (infusional)
- Drug: Leucovorin calcium
- Drug: CT-322
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution)
- interventionNames
- Drug: Irinotecan
- Drug: 5-Fluorouracil (bolus)
- Drug: 5-Fluorouracil (infusional)
- Drug: Leucovorin calcium
- Drug: Bevacizumab
- Drug: Bevacizumab Placebo (saline solution)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 (≤ 8 weeks since last dose) * Available paraffin embedded tumor tissue * Willing to give a whole blood sample for the study of proteins and genetic polymorphisms Exclusion Criteria: * Less than 28 days elapsed since major surgery at time of randomization * Known CNS metastases * Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident * Uncontrolled hypertension * Clinically significant cardiovascular disease * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis * Known HIV Positive
References
Publications (0)
Data not yet available
No reference posted for this study.