Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

NCT02196688 | Completed Phase 2 Results DMC

• 1 other identifier: 2012-013-00CH1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 5

Brief Summary

Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Fruquintinib; 013

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event.

  From randomization until the date of first documented progression or date of death from any cause, whichever came first.

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  From randomization up to progressive disease or end of treatment (EOT) due to any cause.

• Disease Control Rate (DCR)

  From randomization up to progressive disease or EOT due to any cause.

• Over Survival (OS)

  From randomization until death due to any cause.

Study Arms (2)

treatment arm

ACTIVE COMPARATOR

treatment arm- subjects will receive Fruquintinib 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Drug: fruquintinib

control arm

PLACEBO COMPARATOR

control arm- subjects will receive Fruquintinib placebo 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Drug: placebo

Interventions

fruquintinib DRUG

fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

Also known as: HMPL-013

treatment arm

placebo DRUG

Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

Also known as: HMPL-013 placebo

control arm

Eligibility Criteria

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

You may qualify if:

• ≥ 18 and ≤ 75 years of age , with ≥ 40 Kg
• Histological or cytological confirmed metastatic colorectal cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Failed 2 or more lines of chemotherapy
• Adequate hepatic, renal, heart, and hematologic functions
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
• Signed and dated informed consent.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

You may not qualify if:

• Pregnant or lactating women
• Any factors that influence the usage of oral administration
• Central nervous system (CNS) metastasis
• One of the following conditions: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
• Abuse of alcohol or drugs
• Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
• Disability of serious uncontrolled intercurrence infection
• Proteinuria ≥ 2+ (1.0g/24hr)
• Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
• History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
• History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months
• Bone fracture or wounds that was not cured for a long time
• Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead
• Fudan University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (5)

Hutchison Medi Pharma Investigational Site

Beijing, Beijing Municipality, 100071, China

Location

Hutchison Medi Pharma Investigational Site

Guangzhou, Guangdong, 510060, China

Location

Hutchison Medi Pharma

Harbin, Heilongjiang, 150081, China

Location

Hutchison Medi Pharma Investigational Site

Hangzhou, Zhejiang, 310016, China

Location

Hutchison Medi Pharma Investigational Site

Shanghai, 200032, China

Location

Related Publications (1)

• Xu RH, Li J, Bai Y, Xu J, Liu T, Shen L, Wang L, Pan H, Cao J, Zhang D, Fan S, Hua Y, Su W. Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study. J Hematol Oncol. 2017 Jan 19;10(1):22. doi: 10.1186/s13045-016-0384-9.

  PMID: 28103904 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

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

Results Point of Contact

• Title: Dr. Songhua Fan
• Organization: Hutchison Medipharma Ltd

songhuaf@hmplglobal.com

+86 21 2067 3058

Study Officials

• Jin Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 22, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 16, 2020
• Results First Posted: August 13, 2019

Record last verified: 2020-06

Locations

CN (5)