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Non-Small Cell Lung Cancer (NSCLC)Phase 1NCT02364362

A Study of Famitinib Plus Docetaxel in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 study testing famitinib L + docetaxel, famitinib M + docetaxel and famitinib H + docetaxel in people with Non-Small Cell Lung Cancer (NSCLC), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable. This study assessed the safety and maximum tolerated dose of continuous daily treatment with Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Small Cell Lung Cancer (NSCLC)
What is being tested?
famitinib L + docetaxel, famitinib M + docetaxel and famitinib H + docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Jan 2015to Dec 2018
Phase
Phase 1
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

  • Age:18-70 years;
  • ECOG PS (Eastern Cooperative Oncology Group Performance Status)of 0 or 1;
  • Life expectancy of at least 12 weeks;
  • Histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;
  • Relapse or failure of one first line prior platinum-based chemotherapy;EGFR mutation type previously treated with platinum-based chemotherapy and EGFR inhibitors;
  • At least one target tumour lesion that has not been irradiated within the past 3 months and that can accurately be measured ,according to RECIST 1.1;
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  • Participants have adequate organ and marrow function as defined below:
  • Hemoglobin ≥ 90g/L ( no blood transfusion in 2 weeks)
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
  • Platelets(PLT)≥ 100×10^9/L
  • Bilirubin < 1.25×ULN(Upper Limit Of Normal)
  • ALT < 2.5×ULN; ALT < 5×ULN ( If have liver metastases)
  • AST < 2.5×ULN; AST < 5×ULN ( If have liver metastases)
  • Serum creatinine < 1.25×ULN, and endogenous Cr clearance > 45 ml/min(Cockcroft-Gault Formula)
  • Cholesterol ≤ 1.5×ULN and triglyceride≤ 2.5×ULN
  • Left ventricular ejection fraction(LVEF): ≥ LLN(Lower Limit Of Normal) by Color Doppler Ultrasonography
  • Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article;
  • Patient has given written informed consent.

Who cannot join

  • More than one chemotherapy treatment regimen (except,either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) for advanced and/or metastatic or recurrent NSCLC;
  • Previous therapy with other VEGFR inhibitors (including sunitinib,sorafenib,pazopanib,axitinib,other than bevacizumab) or docetaxel for treatment of NSCLC;
  • Radiographical evidence of cavitary or necrotic tumours;
  • Centrally located tumours with radiographical evidence (CT or MRI) of local invasion of major blood vessels;
  • Pre-existing ascites and/or clinically significant pleural effusion;
  • Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 2 before initiating investigational drugs;
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  • History of clinically significant haemoptysis within the past 3 months（24h >half teaspoon）;
  • Current peripheral neuropathy greater than CTCAE grade 2;
  • Other malignancy within the past 3 years other than basal cell skin cancer, or carcinoma in situ of the cervix;
  • Active brain metastases (such as stable time ≤ 4 weeks,no radiotherapy treatment,any symptoms,or seizures treatment needing) or leptomeningeal disease.;
  • Treatment with other investigational drugs or other anti-cancer therapy, or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial;
  • Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
  • Treatment with cytotoxic drugs, radiotherapy(except extremities and brain) , immunotherapy , monoclonal antibody, or TKI inhibitor therapy within the past 4 weeks, being previous anti-cancer treatment interval ≤ 4 weeks.;
  • Patients with hypertension using combination therapy (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg). Patients with unstable angina, myocardial ischemia or myocardial infarction in the past 6 months, congestive heart failure>NYHA II,and arrhythmia (including QTcF interval ≥ 450ms for male and 470ms for female);
  • Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g;
  • History of major thrombotic or clinically relevant major bleeding event in the past 6 months，and known inherited predisposition to bleeding or thrombosis;
  • PT or APTT bias from normal range≥50%;
  • Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues;If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) ， low-dose aspirin (less than 100mg daily) is allowed;
  • Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
  • Diabetes mellitus can not controlled with hypoglycemic agent;
  • Active or chronic hepatitis C and/or B infection with liver dysfunction;
  • History of immunodeficiency disease, concurrent acquired or congenital immunodeficiency,or history of organ transplantation;
  • Serious infections requiring systemic antibiotic therapy;
  • Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
  • Significant weight loss (>10 %) within the past 6 months;
  • Pregnancy , breast feeding or child bearing potential, a positive urine or serum pregnancy test result 7 days before initiating famitinib;
  • Active alcohol or drug abuse;
  • Any contraindications for therapy with docetaxel；History of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80)；Hypersensitivity to famitinib and/or the excipients of the trial drugs；Hypersensitivity to contrast media;
  • Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;
  • Patients unable to comply with the protocol;
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

Other trials in China

About this study

Official title: Docetaxel Plus Famitinib Versus Docetaxel Plus Placebo in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.

This study assessed the safety and maximum tolerated dose of continuous daily treatment with Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II trial.

Being tested
famitinib L + docetaxel, famitinib M + docetaxel, famitinib H + docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • famitinib L + docetaxelDrug

    famitinib 15mg qd + docetaxel 60 mg/m^2

  • famitinib M + docetaxelDrug

    famitinib 20mg qd + docetaxel 60 mg/m^2

  • famitinib H + docetaxelDrug

    famitinib 25mg qd + docetaxel 60 mg/m^2

Study groups in NCT02364362
Study groupRoleWhat they receive
Famitinib + docetaxelExperimentalLow, medium and high dose of famitinib and 60 mg/m^2 docetaxel every 3 weeks
Receives: Drug: famitinib L + docetaxel; Drug: famitinib M + docetaxel; Drug: famitinib H + docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of famitinib in combination with standard-dose docetaxel(60 mg/m^2)

    MTD was defined as the highest dose at which incidence of dose-limiting toxicities(DLTs) in Cyle 1 was ≤33.3%(0/3,1/6,2/6)

    Measured: 3 weeks

Secondary outcomes (7)

  1. Incidences of Adverse Events according to Common Toxicity Criteria (CTC version 4.0) associated with increasing doses of famitinib

    Measured: 1 years

  2. Pharmacokinetics-AUC

    Area under the plasma concentration-time curve (AUC) for famitinib and docetaxel

    Measured: 6 weeks

  3. Pharmacokinetics-Cmax

    Maximum measured plasma concentration (Cmax) for famitinib and docetaxel

    Measured: 6 weeks

  4. Pharmacokinetics-Tmax

    Time from dosing to the maximum plasma concentration (Tmax) for famitinib and docetaxel

    Measured: 6 weeks

  5. Pharmacokinetics-t1/2

    Terminal half-life (t1/2(ss)) for famitinib and docetaxel

    Measured: 6 weeks

  6. Objective Response Rate (ORR)

    Measured: 6 weeks

  7. Progress free survival (PFS)

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364362
Sponsor's protocol ID
HR-FMTN- Ⅱ-NSCLC-COM
Status last verified
Dec 2018
First submitted
19 Jan 2015
Last updated
18 Jan 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing famitinib L + docetaxel, famitinib M + docetaxel and famitinib H + docetaxel in people with Non-Small Cell Lung Cancer (NSCLC), run by Jiangsu HengRui Medicine Co., Ltd. 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 18 inclusion and 31 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 18 Jan 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 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.

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?

Maximum tolerated dose (MTD) of famitinib in combination with standard-dose docetaxel(60 mg/m^2) (time frame: 3 weeks). 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 NCT02364362.

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 18 Jan 2019.

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