Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC
Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC: A Phase Ib Study,Open-label,Dose-expansion Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Yuankai Shi, MD
- E-post: syuankai@yahoo.cn
Studiesteder
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Anhui
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Hefei, Anhui, Kina, 230601
- Rekruttering
- The Second Affiliated Hospital of Anhui Medical University
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Ta kontakt med:
- Hui Zhao, MD
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Beijing
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Beijing, Beijing, Kina, 100032
- Rekruttering
- Peking Union Medical College Hospital
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Ta kontakt med:
- Mengzhao Wang, MD
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Beijing, Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Ta kontakt med:
- Ziping Wang, MD
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Beijing, Beijing, Kina, 100021
- Rekruttering
- Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
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Ta kontakt med:
- Yuankai Shi, MD
- E-post: syuankaipumc@126.com
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Hebei
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Shijiazhuang, Hebei, Kina, 050011
- Har ikke rekruttert ennå
- Fourth Hospital of Hebei Medical University
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Hovedetterforsker:
- Mingxia Wang
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Hovedetterforsker:
- Da Jiang, MD
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Har ikke rekruttert ennå
- Affiliated Cancer Hospital of Harbin Medical University
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Ta kontakt med:
- Yan Yu, MD
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Liaoning
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Shenyang, Liaoning, Kina, 110001
- Rekruttering
- The First Hospital of China Medical University
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Ta kontakt med:
- Yunpeng Liu, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BPI-9016M
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. |
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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Participants with Adverse Events
Tidsramme: 18 months
|
18 months
|
|
Objective Response Rate
Tidsramme: 16 weeks
|
16 weeks
|
|
Disease Control Rate
Tidsramme: 16 weeks
|
16 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Samlet overlevelse
Tidsramme: 24 måneder
|
24 måneder
|
|
Progresjonsfri overlevelse
Tidsramme: 18 måneder
|
18 måneder
|
|
AUCss
Tidsramme: 4 weeks
|
4 weeks
|
|
Css-min
Tidsramme: 18 months
|
18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BD-CM-I02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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