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Metastatic Colorectal CancerPhase 3NCT02870582

Donafenib for Previously Treated Metastatic Colorectal Cancer

A Phase 3 study testing Donafenib in people with Metastatic Colorectal Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Donafenib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
536 participants
Where
2 sitesChina
Study dates
28 Dec 2016to 30 Apr 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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  • Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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.
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  • 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);

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • the 307th Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100071

  • West China Hospital Sichuan

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Efficacy and Safety of Donafenib in Patients With Previously Treated Metastatic Colorectal Cancer:a Controlled,Multicentre,Randomised, Phase 3 Trial

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.

Read the detailed description

The study is a randomization,multicentre, phase 3 study recruiting 510 patients. 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.

All patients receive best supportive care, excluding other investigational antitumour agents or antineoplastic chemotherapy, hormonal therapy, or immunotherapy.

Patients receive oral donafenib 300mg (CM4307) on days 1-21 of each 4 weeks cycle until disease progression,death,or the unacceptable toxic effects.The primary endpoint is overall survival.The second endpoint is progression-free survival.

Being tested
Donafenib, Placebo
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonafenibDrug

    Also called CM4307

    treatment drug

  • PlaceboDrug

    Also called Controlled

    Best support treatment

Study groups in NCT02870582
Study groupRoleWhat they receive
DonafenibExperimentalDonafenib 300mg bid on 1-21 days of each 28 days cycle.
Receives: Drug: Donafenib
PlaceboPlacebo comparatorPlacebo 300mg bid on 1-21days of each 28 days cycle.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Progression-free Survival (PFS)

    PFS was defined as the time from date of randomization to disease progression radiological or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

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

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

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

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

    AE evaluated by CTCAE

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study start28 Dec 2016
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
536 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870582
Sponsor's protocol ID
ZGDC3
Status last verified
Nov 2022
First submitted
12 Aug 2016
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No plan to share date of the trial

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Donafenib in people with Metastatic Colorectal Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization of the first subject until 316 death events observed, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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