Lung CancerPhase 2NCT03684967
Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC
A Phase 2 study testing Fruquintinib in people with Lung Cancer, run by Hutchison Medipharma Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Fruquintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2018to 6 Sep 2019
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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:
- Absolute neutrophil count (ANC) <1.5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 2 week prior to administration of the study drug
- Serum total bilirubin > 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate aminotransferase >2.5×ULN (according to reference range in each clinical study site); ALT and AST > 5×ULN in patients with liver metastasis
- Clinically significant electrolyte abnormality
- Blood creatinine > ULN and creatinine clearance <50 ml/min
- Urine protein 2+ or more, or urine protein quantification ≥1.0 g/24 h
- Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) > 1.5×ULN (according to reference range in each clinical study site)
- Patients with uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after symptomatic treatment
- Cardiac function: left ventricular ejection fraction <50% (by echocardiography); moderate or above mitral or tricuspid insufficiency; acute myocardial infarction, serious/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to randomization; or New York heart association (NYHA) grade 2 or above cardiac insufficiency
- Patients who have a history of arterial thrombosis or deep venous thrombosis within 6 months prior to administration of the study drug; history or evidence of thrombosis or bleeding tendency regardless of the severity within 2 months; history of hemoptysis (i.e. coughing blood in bright red color at least 2.5ml or 1/2 teaspoon) within 2 weeks; history of liver hemangioma > 3 cm
- Patients who have a history of stroke and/or transient ischemic attack within 12 months prior to administration of the study drug
- Patients with skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing
- Pregnant or lactating women, or women of child bearing potential with positive pregnancy test result before the first dose; Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures
- Patients with any clinical or laboratory abnormalities unsuitable for participating in this clinical trial according to the investigator's judgment
- Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study
- Patients who are allergic to analogue of Fruquintinib and/or its inactive ingredients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Single Arm Multi-center Phase II Study to Assess Fruquintinib in High Risk Patients With Advanced Non-squamous Non-small Cell Lung Cancer
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.
Read the detailed description
This is an open-label single arm multi-center phase II study to assess the efficacy and safety of Fruquintinib in high risk patients with advanced NSCLC who is > 75 years, or ECOG PS = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.
After checking eligibility criteria, subjects will take Fruquintinib as below: 4 mg once daily in the Cycle 1, administration for 3 weeks followed by 1 week break. 5mg once daily in followed cycles, administration for 3 weeks followed by 1 week break.
Primary Efficacy Endpoint:
Disease Control Rate (DCR) (According to RECIST Version 1.1). Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary Efficacy Endpoints:
Objective Response Rate (ORR), Duration of Response (DOR), Progression free survival (PFS), Overall Survival (OS) and Quality of Life (QoL).
- Conditions
- Lung Cancer
- Being tested
- Fruquintinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
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
| Study group | Role | What they receive |
|---|---|---|
| fruquintinib | Experimental | Fruquintinib treatment: administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days. Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: from the first dose to 30 days post the last dose
Secondary outcomes (5)
Objective response rate (ORR)
Tumor assessment will be performed using radiography method at the first 4th week and 8th week after the first dose, then every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1.
Measured: 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)
Tumor assessment will be performed using radiography method at the first 4th week and 8th week after the first dose, then every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1.
Measured: 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)
Tumor assessment will be performed using radiography method at the first 4th week and 8th week after the first dose, then every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1.
Measured: from the first dose until progressive disease or EOT due to any cause, whichever came first, assessed up to 1 year
Overall survival (OS)
Every two months follow up after EOT observation period at 30 days after the last medication
Measured: from the first dose until death due to any cause, assessed up to 3 year
Quality of Life (QoL)
The change of QoL will be assessed by the EORTC Quality of Life Questionnaire Core-30 (QLQ-C30) plus QLQ-Lung Cancer 13-item (LC13) ( LC13 is a supplementary module plus QLQ-C30 as one complete measure) every 4 weeks. A descriptive statistics analysis will be used to look at QoL over the time course.
Measured: from the first dose to 30 days post the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start8 May 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Why it stopped: the study stopped because the company's strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03684967
- Sponsor's protocol ID
- 2017-013-00CH2
- Status last verified
- Nov 2018
- First submitted
- 23 Aug 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single Arm Multi-center Phase II Study to Assess Fruquintinib in High Risk Patients With Advanced Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03684967
- Acronym / sponsor ID
- 2017-013-00CH2
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study stopped because the company's strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- 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.
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.
Detailed description
This is an open-label single arm multi-center phase II study to assess the efficacy and safety of Fruquintinib in high risk patients with advanced NSCLC who is > 75 years, or ECOG PS = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.
After checking eligibility criteria, subjects will take Fruquintinib as below: 4 mg once daily in the Cycle 1, administration for 3 weeks followed by 1 week break. 5mg once daily in followed cycles, administration for 3 weeks followed by 1 week break.
Primary Efficacy Endpoint:
Disease Control Rate (DCR) (According to RECIST Version 1.1). Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary Efficacy Endpoints:
Objective Response Rate (ORR), Duration of Response (DOR), Progression free survival (PFS), Overall Survival (OS) and Quality of Life (QoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fruquintinib | Experimental | Drug: FruquintinibFruquintinib treatment: administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
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 |
|---|---|---|
| FruquintinibFruquintinib 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 | Drug | fruquintinib |
Primary outcome
Disease Control Rate (DCR)
Time frame: from the first dose until progressive disease or End of Therapy (EOT) due to any cause, whichever came first, assessed up to 8 weeks.
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.
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Time frame: from the first dose to 30 days post the last dose
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
5 secondary outcomes
Objective response rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: from the first dose until progressive disease or EOT due to any cause, whichever came first, assessed up to 1 year
Overall survival (OS)
Time frame: from the first dose until death due to any cause, assessed up to 3 year
Quality of Life (QoL)
Time frame: from the first dose to 30 days post the last dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib in people with Lung Cancer, run by Hutchison Medipharma Limited at 1 site 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 10 inclusion and 30 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: withdrawn, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
Disease Control Rate (DCR) (time frame: from the first dose until progressive disease or End of Therapy (EOT) due to any cause, whichever came first, assessed up to 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019.