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

NCT02929290 | Unknown Phase 1

• 1 other identifier: BD-CM-I02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Participants with Adverse Events

  18 months

• Objective Response Rate

  16 weeks

• Disease Control Rate

  16 weeks

Secondary Outcomes (4)

• AUCss

  4 weeks

• Css-min

  18 months

• Progression-Free Survival

  18 months

• Overall Survival

  24 months

Study Arms (1)

BPI-9016M

EXPERIMENTAL

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.

Drug: BPI-9016M

Interventions

BPI-9016M DRUG

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.

Also known as: No other name so far

BPI-9016M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (7)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

NOT YET RECRUITING

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37041472 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yuankai Shi, MD

CONTACT

syuankai@yahoo.cn

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: October 7, 2016
• First Posted: October 11, 2016
• Study Start: March 1, 2017
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)