Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CM4307
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, CM4307, Previously treated metastatic colorectal cancer
Eligibility 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.
Sites / Locations
- West China Hospital,SCU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CM4307
Arm 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
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events
Secondary Outcome Measures
Progression Free Survival
Full Information
NCT ID
NCT02489916
First Posted
September 28, 2014
Last Updated
January 3, 2016
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02489916
Brief Title
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer
Official Title
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer: Multicentre, Open-label,Phase 1B Safety Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Metastatic Colorectal Cancer, CM4307, Previously treated metastatic colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CM4307
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
CM4307
Other Intervention Name(s)
Donafenib
Intervention Description
CM4307 300mg bid, each 4 week cycle
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
54 weeks
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
54 weeks
Other Pre-specified Outcome Measures:
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Bi, Doctor
Organizational Affiliation
West China Hospital,SCU
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital,SCU
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Learn more about this trial
Donafenib Monotherapy for Previously Treated Metastatic Colorectal Cancer
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