Donafenib for Previously Treated Metastatic Colorectal Cancer

NCT02870582 | Completed Phase 3 DMC

• 1 other identifier: ZGDC3
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators do the clinical trial (patients with metastatic colorectal cancer treated with donafenib/placebo after failure of standard therapy) to assess efficacy and safety of donafenib in patients with metastatic colorectal cancer, progressing after all approved standard therapies.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

  From randomization of the first subject until 316 death events observed, up to 2 years

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  From randomization of the first subject until 316 death events observed, up to 2 years

• Disease Control Rate (DCR)

  From randomization of the first subject until 316 death events observed, up to 2 years

• Safety variables will be summarized using descriptive statistics based on adverse events collection

  From randomization of the first subject until 316 death events observed, up to 2 years

Study Arms (2)

Donafenib

EXPERIMENTAL

Donafenib 300mg bid on 1-21 days of each 28 days cycle.

Drug: Donafenib

Placebo

PLACEBO COMPARATOR

Placebo 300mg bid on 1-21days of each 28 days cycle.

Drug: Placebo

Interventions

Donafenib DRUG

treatment drug

Also known as: CM4307

Donafenib

Placebo DRUG

Best support treatment

Also known as: Controlled

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological documentation of adenocarcinoma of the colon or rectum;
• Subjects with metastatic colorectal cancer and must have progressed during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan:
• Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy;
• Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible;
• Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study;
• Subjects may have received prior treatment with bevacizumab and/or cetuximab/panitumumab.
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 1;
• Life expectancy of at least 3 months;
• Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol conducted within 7 days before randomization (platelets \>80× 109/L, neutrophil \> 1.5 × 109/L, Hb≥85g/L, serum creatinine ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN, and serum transaminase≤2.5×ULN or ≤5.0ULN if liver involvement);

You may not qualify if:

• Prior treatment with TKIs.
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
• Subjects who have no evaluable lesion except Pleural effusion, ascites or bone metastases lesion;
• Major surgery have been completed within 4 weeks before the first dose of study medicine.
• Subjects who have open wounds, active ulcers or plural stomata;
• Subjects who have completed radiotherapy or systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks before the first dose of study medicine;
• Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
• Pleural effusion or ascites that causes respiratory compromise.
• Arterial or venous thrombotic or embolic events.
• Any history of or currently known brain metastases.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (2)

the 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

Location

West China Hospital Sichuan

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

donafenib; Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Bi Feng, MD

  West China Hospital

  STUDY CHAIR

• Xu Jianming, MD

  The Affiliated Hospital of Military Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: December 28, 2016
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)