Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04322539 · ClinicalTrials.gov registry record · Phase 3
A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Hutchison Medipharma Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 691
- Enrollment target
NCT04322539: Completed Phase 3 study, sponsored by Hutchison Medipharma Limited.
NCT04322539 is a Phase 3 study that has completed, run by Hutchison Medipharma Limited. The registered enrollment target is 691 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04322539, a Phase 3 study, has completed, sponsored by Hutchison Medipharma Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 691 participants
- Enrollment target
Study Summary
This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.
Primary Outcome
OS was defined as the time (months) from date of randomization to death from any cause. OS was calculated as (date of death or last known alive - date of randomization + 1)/30.4375. Participants without report of death at the time of analysis will be censored at the date last known alive.
Interventions
- DRUG Placebo
- DRUG Fruquintinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 691 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2024-04-24 |
| Phase | Phase 3 |
What the finished NCT04322539 record still lists
NCT04322539 is an interventional study that assigns participants to a tested intervention. The registered 691 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04322539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04322539 about?
NCT04322539 is a clinical study titled "A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer". This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were ran...
What is the current status of trial NCT04322539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 691 participants. The study started on 2020-08-12. Estimated completion is 2024-04-24.
What interventions are being tested in trial NCT04322539?
The interventions under investigation include: Placebo (DRUG), Fruquintinib (DRUG).
Who is sponsoring clinical trial NCT04322539?
This trial is sponsored by Hutchison Medipharma Limited, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04322539's enrollment target sits among peer trials
691 524th of 2000 higher than 1,477 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07382167 · 692 participants · Phase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
- NCT00532051 · 690 participants
Intraocular Lens Power Calculation After Laser Refractive Surgery Based on Optical Coherence Tomography
- NCT05184335 · 690 participants · Phase 3
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
- NCT07221149 · 690 participants · Phase 2
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI