Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer: Multicentre, Open-label,Phase 1B Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489916
• Other study ID #: ZGDC1B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 28, 2014
• Last updated: January 3, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The study is a multicentre, phase 1B study recruiting 47 patients in 6 sites. Patients were eligible to participate when they have histological or cytological documentation of adenocarcinoma of the colon or rectum. They must 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. The available standard therapies have to include 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.

Patients have to be aged 18 years or older and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; life expectancy of at least 3 months;and adequate bone-marrow, liver, and renal function at the start of the trial. Patients could not participate if they had previously received sorafenib or had uncontrolled medical disorders.

All patients receive best supportive care, excluding other investigational antitumour agents or antineoplastic chemotherapy, hormonal therapy, or immunotherapy. Patients receive oral donafenib 300mg (CM4307) of each 4 week cycle until disease progression,death, unacceptable toxic effects, withdrawal of consent by the patient, or decision by the treating physician that discontinuation would be in the patient's best interest.The primary endpoint is safety.The second endpoint is progression-free survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• CM4307
CM4307 300mg bid, each 4 week cycle

Locations

Country	Name	City	State
China	West China Hospital,SCU	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area under the plasma concentration versus time curve (AUC)		4 weeks	No
Primary	Number of participants with Adverse Events		54 weeks	Yes
Secondary	Progression Free Survival		54 weeks	No