Clinical trial · Interventional
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer: Multicentre, Open-label,Phase 1B Safety Study
NCT02489916CI-TRIAL-00020422completedPhase 1 / Phase 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 investigators do the clinical trial (patients with metastatic colorectal cancer treated with donafenib after failure of standard therapy) to assess safety and efficacy of donafenib in patients with metastatic colorectal cancer, progressing after all approved standard therapies.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM4307 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CM4307
- description
- CM4307 300mg bid，until disease progression,death, unacceptable toxic eff ects, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest
- interventionNames
- Drug: CM4307
Primary outcomes (1)
- measure
- Number of participants with Adverse Events
- timeFrame
- 54 weeks
Secondary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 54 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Have histological or cytological documentation of adenocarcinoma of the colon or rectum; * Have received locally and currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects. * Standard therapies including as many of the following as were licensed: a fluoropyrimidine,oxaliplatin, irinotecan, and bevacizumab;and cetuximab or panitumumab for patients who had KRAS wild-type tumours; * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Life expectancy of at least 3 months; * Have adequate bone-marrow, liver, and renal function at the start of the trial. * Prothrombin time international normalized ratio≤2；or prothrombin time≤16 seconds;or activated partial thromboplastin time(APTT) ≤43 seconds;or TT≤21 seconds. Exclusion Criteria: * Patients have prior treatment with sorafenib; * Patients have Central nervous system(CNS) involvement; * patients have uncontrolled medical disorders.
References
Publications (0)
Data not yet available
No reference posted for this study.