A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Patients With Metastatic Colorectal Cancer (FRESCO-2)
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|ClinicalTrials.gov Identifier: NCT04322539|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer Metastatic Colon Cancer||Drug: Fruquintinib Drug: Placebo||Phase 3|
This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in advanced colorectal cancer patients who have progressed on, or were intolerant to, chemotherapy, biologics, and TAS-102 or regorafenib. Patients with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.
Metastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||687 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: fruquintinib plus best supportive care
In this arm, subjects will receive active study drug plus best supportive care
Oral VEGFR inhibitor
Other Name: HMPL-013
Placebo Comparator: placebo plus best supportive care
In this arm, subjects will receive placebo plus best supportive care
- Overall Survival [ Time Frame: up to 10 years ]To evaluate the overall survival of fruquintinib plus BSC compared to placebo plus BSC in subjects with refractory mCRC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322539
|Contact: Alberto Fernandezfirstname.lastname@example.org|
|Contact: Keneikia Morganemail@example.com|
|Study Director:||William Schelman, MD, PhD||Hutchison MediPharma International|