Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC

NCT03684967 | Withdrawn Phase 2 DMC

• 1 other identifier: 2017-013-00CH2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Fruquintinib administered at 4 mg once daily in cycle 1 and 5 mg once daily in followed cycles (3 weeks on and 1 week off, 4 weeks as 1 cycle) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced NSCLC in phase II study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of high risk patients with advanced NSCLC who is \> 75 years, or Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Disease Control Rate (DCR)

  Tumor assessment will be performed using radiography method at the first 4th week and 8th week after the first dose, or until the occurrence of progressive disease (PD), using RECIST v 1.1.

  from the first dose until progressive disease or End of Therapy (EOT) due to any cause, whichever came first, assessed up to 8 weeks.

• Safety and tolerance evaluated by incidence, severity and outcomes of AEs

  Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.03

  from the first dose to 30 days post the last dose

Secondary Outcomes (5)

• Objective response rate (ORR)

  from the first dose until progressive disease or EOT due to any cause, whichever came first, assessed up to 1 year

• Duration of Response (DOR)

  from the first dose until progressive disease or EOT due to any cause, whichever came first, assessed up to 1 year

• Progression free survival (PFS)

  from the first dose until progressive disease or EOT due to any cause, whichever came first, assessed up to 1 year

• Overall survival (OS)

  from the first dose until death due to any cause, assessed up to 3 year

• Quality of Life (QoL)

  from the first dose to 30 days post the last dose

Study Arms (1)

fruquintinib

EXPERIMENTAL

Fruquintinib treatment: administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days

fruquintinib

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients
• Epidermal growth factor receptor (EGFR) mutation wild type; or EGFR activating mutation and resistant / intolerant to related targeted therapies
• Anaplastic lymphoma kinase (ALK) mutation negative; or ALK mutation positive and resistant / intolerant to related targeted therapies
• Presence of at least one measurable tumor lesion in accordance with RECIST 1.1 criteria
• Expected survival \> 12 weeks
• Queue 1: 1) Age \> 75 years 2) Disease progression during or within 3 months after first-line systemic chemotherapy; or intolerable toxicity / intolerance during first-line systemic chemotherapy (excluding immunotherapy); or without systemic chemotherapy (rejected or intolerable), judged by investigators 3) Eastern Cooperative Oncology Group (ECOG) of 0-1
• Queue 2: 1) Age 18-75 years old (including 18 and 75 years old) 2) Disease progression during or within 3 months after first-line systemic chemotherapy; or intolerable toxicity / intolerance during first-line systemic chemotherapy (excluding immunotherapy); or without systemic chemotherapy (rejected or intolerable), judged by investigators 3) Eastern Cooperative Oncology Group (ECOG) of 2
• Queue 3: 1) Age 18-75 years old (including 18 and 75 years old) 2) without systemic chemotherapy 3) Eastern Cooperative Oncology Group (ECOG) of 0-1
• Queue 4: 1) Age 18-75 years old (including 18 and 75 years old) 2) Disease progression during or within 3 months after at least three lines systemic chemotherapy; or intolerable toxicity / intolerance during at least third-line systemic chemotherapy (excluding immunotherapy) 3) Eastern Cooperative Oncology Group (ECOG) of 0-1

You may not qualify if:

• Patients who have participated in another clinical trial or received systemic anti-neoplastic chemotherapy, biotherapy or immunotherapy within 3 weeks prior to administration of the study drug; or received target drugs treatment as EGFR - Tyrosine Kinase Inhibitors (TKIs), ALK inhibitors, within in 2 weeks; or received anti-neoplastic traditional Chinese medicine within 1 week; or received pleural infusion chemotherapy within 1 week.
• Patients who have received palliative radiotherapy within 1 week prior to administration of the study drug; or received radical / extensive radiotherapy within 3 weeks; or received brachytherapy within 60 days (as seed implantation)
• Patients who have previously received therapy with VEGFR inhibitors
• Patients who have previously received potent inhibitor and/or potent inducer of cytochrome P450 3A4 (CYP3A4) within two 2 weeks prior to administration of the study drug; receiving P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) substrate drugs within two 2 weeks prior to randomization
• Patients who have previously received major surgery or large invasive procedure within 60 days prior to administration of the study drug, or incomplete recovery from previous surgery/procedure, or incomplete healing of surgical incision/wound; no recovery of the toxicity from previous antitumor therapies (i.e., CTCAE grade \> 1) (if applicable)
• Patients with brain metastasis
• Patients with spinal compression with no surgical therapy and/or radical radiotherapy; or previously treated spinal compression, however, no clinical evidence showing stable condition
• Radiological evidence showing tumor invading or encompassing major blood vessels of lungs (e.g., pulmonary artery, superior vena cava)
• Patients with other primary malignancies within the past 5 years except basal cell carcinoma of skin or carcinoma in situ of cervix
• Patients with uncontrolled active infections, e.g. acute pneumonia
• Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, hepatitis B virus (HBV) DNA ≥500copies or ≥ 100IU / ml)
• Patients with human immunodeficiency virus (HIV) infection
• Patients with dysphagia or known drug malabsorption
• Patients active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula
• Patients fulfilling any of the following criteria shall be excluded:

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 26, 2018
• Study Start: May 8, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: November 19, 2019

Record last verified: 2018-11

Locations

CN (1)