AzTrials
AzTrials

Non-small Cell Lung CancerPhase 1NCT02929290

Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC

A Phase 1 study testing BPI-9016M in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC. Biomarkers related to the efficacy of BPI-9016M will be investigated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
BPI-9016M
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
7 sitesChina
Study dates
1 Mar 2017to Nov 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
  • Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Life expectancy ≥12 weeks
  • Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations；Must haved evidence of MET exon 14 skipping alterations in blood and/or tissue samples.
  • Adequate bone marrow, hepatic, and renal function
  • Patients of child bearing potential must agree to take contraception during the study and for 3 months after the last day of treatment
  • Signed Informed Consent Form

Who cannot join

  • Prior or current treatment with the type II of c-MET inhibitor or HGF/c-Met antibody therapy
  • Confirmed ALK or ROS1 rearrangement
  • Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs,the tpye I of MET TKIs, etc.) within 14 days or 5 half-life
  • Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks
  • Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
  • History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion
Show all 12Show fewer
  • Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
  • Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  • History of organ transplant; had surgery or severe injury within 4 weeks
  • Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ）
  • Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption.
  • Pregnant (positive pregnancy test) or lactating women

Trial locations and contacts

7 sites in 1 country.

Yuankai Shi, MD contact

syuankai@yahoo.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, MD, syuankaipumc@126.com

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

    Mengzhao Wang, MD

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Ziping Wang, MD

    Recruiting

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Yan Yu, MD

    Not yet recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    hui zhao, MD

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Yunpeng Liu, MD

    Recruiting

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Da Jiang, MD

    Da Jiang, MD

    Not yet recruiting

Other trials in China

About this study

Official title: Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC: A Phase Ib Study,Open-label,Dose-expansion Study

The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC. Biomarkers related to the efficacy of BPI-9016M will be investigated.

Read the detailed description

This study was a multicenter, open, single-arm, Ib-stage expanded clinical study.

Part I：On the basis of Ia-stage dose escalation study, a safe and effective dose of -300 mg, 450 mg, 600 mg and 800 mg was selected to enlarge the enrollment study in patients with c-Met-dysregulated advanced NSCLC, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.

Part II：On the basis of the completed research results of Ia stage and part I, a safe and effective dose of 400 mg twice a day (bid) was selected to conduct an expanded enrollment study in NSCLC patients with MET exon 14 skipping alterations, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.

Being tested
BPI-9016M
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.

  • BPI-9016MDrug

    Also called No other name so far

    Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort.

    Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day.

Study groups in NCT02929290
Study groupRoleWhat they receive
BPI-9016MExperimentalPart I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day.
Receives: Drug: BPI-9016M

What is being measured

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

  1. Participants with Adverse Events

    Measured: 18 months

  2. Objective Response Rate

    Measured: 16 weeks

  3. Disease Control Rate

    Measured: 16 weeks

Secondary outcomes (4)

  1. AUCss

    Measured: 4 weeks

  2. Css-min

    Measured: 18 months

  3. Progression-Free Survival

    Measured: 18 months

  4. Overall Survival

    Measured: 24 months

Timeline

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

  1. First posted11 Oct 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02929290
Sponsor's protocol ID
BD-CM-I02
Status last verified
Sep 2021
First submitted
7 Oct 2016
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hu X, Cui X, Wang Z, Liu Y, Luo Y, Zhong W, Zhao H, Yao M, Jiang D, Wang M, Chen M, Zheng X, Ding L, Wang Y, Yuan X, Wu P, Hu B, Han X, Shi Y. Safety, efficacy and pharmacokinetics of BPI-9016M in c-MET overexpression or MET exon 14 skipping mutation patients with locally advanced or metastatic non-small-cell lung cancer: a phase Ib study. BMC Cancer. 2023 Apr 11;23(1):331. doi: 10.1186/s12885-022-10500-y.

    PubMed 37041472

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BPI-9016M in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 7 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 12 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: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuankai Shi, MD (syuankai@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants with Adverse Events (time frame: 18 months). 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 NCT02929290, 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 13 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in