Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer

NCT02489916 | Completed Phase 1

• 1 other identifier: ZGDC1B
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer; CM4307; Previously treated metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  54 weeks

Secondary Outcomes (1)

• Progression Free Survival

  54 weeks

Other Outcomes (1)

• Area under the plasma concentration versus time curve (AUC)

  4 weeks

Study Arms (1)

CM4307

EXPERIMENTAL

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

Drug: CM4307

Interventions

CM4307 DRUG

CM4307 300mg bid, each 4 week cycle

Also known as: Donafenib

CM4307

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients have prior treatment with sorafenib;
• Patients have Central nervous system(CNS) involvement;
• patients have uncontrolled medical disorders.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

West China Hospital,SCU

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

donafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Feng Bi, Doctor

  West China Hospital,SCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: July 3, 2015
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2014-10

Locations

CN (1)