NCT02415023

Brief Summary

An open-label, dose escalation and maximum tolerated dose (MTD) and/or recommended phase II dose (RPTD) study of fruquintinib combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 gastric-cancer

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1 gastric-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

April 1, 2015

Last Update Submit

February 13, 2020

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

  • incidence of DLT

    every subject's DLT observation window is 4 weeks

  • progression free survival of RP2D

    using RECIST v1.1 progressive disease (PD), using RECIST v 1.1

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

  • safety and tolerance

    Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.

    From first dose to within 30 days after the last dose

Secondary Outcomes (3)

  • Objective response rate (ORR)

    from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year]

  • Disease control rate (DCR)

    From first dose up to progressive disease or EOT due to any cause, assessed up to 1 year]

  • Pharmacokinetic profiles of Fruquintinib combined with Paclitaxel

    From first dose up to day 15 in the first 28-day cycle

Study Arms (1)

fruquintinib+paclitaxel

EXPERIMENTAL

fruquintinib combined with paclitaxel. Fruquintinib treatment: administration for 3 weeks followed by 1-week break, and administration every day for the first 21 days.Paclitaxel is administered once weekly in the first three weeks of each cycle.

Drug: fruquintinib+paclitaxel

Interventions

fruquintinib+paclitaxelDRUG

28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2

Also known as: HMPL-013+paclitaxel
fruquintinib+paclitaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully understand the study and sign the informed consent form voluntarily;
  • Patients with local advanced and/or metastatic gastric cancer confirmed by histology and/or cytology;
  • Fail in previous first-line standard chemotherapy
  • Aged 18-70years (inclusive);
  • Body weight ≥40 kg;
  • At least one measurable lesion (according to RECIST1.1);
  • Physical status score (ECOG score) 0-1;
  • Expected survival \>12 weeks.

You may not qualify if:

  • Who are participating in another drug clinical trial in the past 4 weeks; or receive systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 4 weeks prior to administration of the study drug;
  • Who previously received VEGF/VEGFR inhibitors;
  • Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE\>grade 1), or not completely recovered from previous surgery;
  • Active brain metastasis(with clinical symptom);
  • Other malignancies except squamous-cell or basal cell carcinoma, and cervical carcinoma in situ in the past 5 years;
  • Uncontrolled clinical active infection, e.g. acute pneumonia, hepatitis B or active hepatitis C;
  • Dysphagia, intractable vomiting or known drug malabsorption;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Hutchison Medi Pharma Investigational Site

Beijing, 100142, China

Location

Hutchison Medi Pharma Investigational Site

Shanghai, 200032, China

Location

Related Publications (1)

  • 1. The 16th Annual Meeting of Chinese Society of Clinical Oncology (CSCO) 2013 2. Elkerm YM, Elesaid A, AL-Batran, et al. Final results of a phase II trial of docetaxel-carboplatin- FU in locally advanced gastric carcinoma[abstract]. Presented at the 2008 gastrointestinal cancers symposium 2008.

    RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 14, 2015

Study Start

November 9, 2014

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

February 17, 2020

Record last verified: 2018-02

Locations

CN(3)