Gastric CancerPhase 1/2NCT02415023
A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric Cancer
A Phase 1/2 study testing fruquintinib+paclitaxel in people with Gastric Cancer, run by Hutchison Medipharma Limited at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- fruquintinib+paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesChina
- Study dates
- 9 Nov 2014to 31 Mar 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hutchison Medi Pharma Investigational Site
Beijing, 100142
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hutchison Medi Pharma Investigational Site
Shanghai, 200032
About this study
Official title: A Phase Ib/2 Clinical Study to Evaluate the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of Fruquintinib Combined With Paclitaxel in Patients With Advanced Gastric Cancer
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.
Read the detailed description
In dose escalation period, 12-24 patients with advanced gastric cancer will be enrolled. Patients meeting enrollment eligibility will receive 28-day cycles of fruquintinib 2-5 mg qd combined with paclitaxel 80 mg/m2. Safety information and pharmacokinetic data will be collected till disease progression or intolerable toxicity to determine MTD and/or RPTD of fruquintinib combined with paclitaxel in patients with advanced gastric cancer. This period will include the following 4 dose groups from low to high:
A: Fruquintinib 2 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle B: Fruquintinib 3 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle C: Fruquintinib 4 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle D: Fruquintinib 5 mg qd for 3 weeks followed by 1-week break + paclitaxel 80mg/m2 once a week during the first three weeks of each cycle This study will use traditional 3+3 trial design (3 subjects will be enrolled in each dose group first. If 1 case of DLT is observed, additional 3 subjects will be enrolled in the same dose group to further evaluate toxicity) to observe DLT and evaluate MTD. If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. At least 6 subjects are required in MTD dose group for confirmation. If MTD is not achieved at the end of dose escalation and there are 6 subjects in the highest dose group, RPTD can be determined based on obtained safety, tolerability, PK and efficacy information. Dose escalation and study in the next dose group can be initiated only after the first treatment cycle (DLT window observation period) is completed and subject safety and tolerability are confirmed in this dose group (0/3 or ≤1/6 subjects experience DLT).
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
- Conditions
- Gastric Cancer
- Being tested
- fruquintinib+paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinib+paclitaxelDrug
Also called HMPL-013+paclitaxel
28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: fruquintinib+paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of DLT
Measured: 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
Measured: 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.
Measured: From first dose to within 30 days after the last dose
Secondary outcomes (3)
Objective response rate (ORR)
using RECIST v 1.1
Measured: from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year]
Disease control rate (DCR)
using RECIST v 1.1
Measured: 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
PK sampling of Fruquintinibwill include a pre-dose and 1,2,4,8,24 hours time-point at Day 2 and day 15 of dosing in the first 28-day cycle; PK sampling of Paclitaxel will include a pre-dose and at 0.25,1,2,4,8, and 24 hours time-point on day 1 and day 15 of dosing in the first 28-day cycle
Measured: From first dose up to day 15 in the first 28-day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start9 Nov 2014
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415023
- Sponsor's protocol ID
- 2014-013-00CH3
- Status last verified
- Feb 2018
- First submitted
- 1 Apr 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/2 Clinical Study to Evaluate the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of Fruquintinib Combined With Paclitaxel in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02415023
- Acronym / sponsor ID
- 2014-013-00CH3
- Conditions
- Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2014 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In dose escalation period, 12-24 patients with advanced gastric cancer will be enrolled. Patients meeting enrollment eligibility will receive 28-day cycles of fruquintinib 2-5 mg qd combined with paclitaxel 80 mg/m2. Safety information and pharmacokinetic data will be collected till disease progression or intolerable toxicity to determine MTD and/or RPTD of fruquintinib combined with paclitaxel in patients with advanced gastric cancer. This period will include the following 4 dose groups from low to high:
A: Fruquintinib 2 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle B: Fruquintinib 3 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle C: Fruquintinib 4 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle D: Fruquintinib 5 mg qd for 3 weeks followed by 1-week break + paclitaxel 80mg/m2 once a week during the first three weeks of each cycle This study will use traditional 3+3 trial design (3 subjects will be enrolled in each dose group first. If 1 case of DLT is observed, additional 3 subjects will be enrolled in the same dose group to further evaluate toxicity) to observe DLT and evaluate MTD. If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. At least 6 subjects are required in MTD dose group for confirmation. If MTD is not achieved at the end of dose escalation and there are 6 subjects in the highest dose group, RPTD can be determined based on obtained safety, tolerability, PK and efficacy information. Dose escalation and study in the next dose group can be initiated only after the first treatment cycle (DLT window observation period) is completed and subject safety and tolerability are confirmed in this dose group (0/3 or ≤1/6 subjects experience DLT).
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fruquintinib+paclitaxel | Experimental | Drug: fruquintinib+paclitaxelfruquintinib 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fruquintinib+paclitaxelAlso: HMPL-013+paclitaxel28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2 | Drug | fruquintinib+paclitaxel |
Primary outcome
incidence of DLT
Time frame: every subject's DLT observation window is 4 weeks
progression free survival of RP2D
Time frame: from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year
using RECIST v1.1 progressive disease (PD), using RECIST v 1.1
safety and tolerance
Time frame: From first dose to within 30 days after the last dose
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.
3 secondary outcomes
Objective response rate (ORR)
Time frame: from first dose up to progressive disease or EOT due to any cause, assessed up to 1 year]
Disease control rate (DCR)
Time frame: 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
Time frame: From first dose up to day 15 in the first 28-day cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication1. 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fruquintinib+paclitaxel in people with Gastric Cancer, run by Hutchison Medipharma Limited at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of DLT (time frame: every subject's DLT observation window is 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.