Clinical trial · Interventional
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen
- 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)
CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of 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 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU (fluorouracil) | Drug | Fluorouracil | ALIAS |
| CT-2106 | Drug | — | UNRESOLVED |
| Folinic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
- timeFrame
- Each cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA * At least one measurable lesion according to RECIST criteria for both Phase I and II * ECOG performance status 0 or 1 * Adequate hematologic, renal and hepatic function * Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy Exclusion Criteria: * Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix. * Pregnant or lactating patients * Prior treatment with camptothecins * Presence or history of CNS metastasis or carcinomatous leptomeningitis * Current active infection per investigator assessment * Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis * Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)
References
Publications (0)
Data not yet available