Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Criteria

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.