We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05439993
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Zang, Dae Young, Hallym University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced gastric and gastroesophageal junction carcinomas (AGC/GEJCs) with MET amplification or MET exon 14 alterations. This study is devided into Phase 1b and Phase 2 study.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal-junction Cancer Drug: Tepotinib plus paclitaxel Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of Tepotinib in Combination With Paclitaxel in Patients With MET Amplified or MET Exon 14 Alterated Advanced Gastric and Gastroesophageal Junction Carcinoma
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tepotinib plus paclitaxel arm Drug: Tepotinib plus paclitaxel
Paclitaxel 80mg/m2 on D1, 8, 15 tepotinib 250mg or 500mg daily on D1-28 Q 4weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression-free survival rate (PFSR) at 4 months [ Time Frame: PFSR at 4 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have the willingness to sign a written informed consent document prior to any study specific precedures
  2. Age ≥ 19 years of male and female

  3. At each phase of the trial, subjects who meet the following requirements in the appropriate phase will be enrolled.

    A. Phase 1b: Subjects with a histologically confirmed metastatic solid tumor that have progressed after treatment with approved therapies or for which there is no standard effective therapy available.

    B. Phase 2b: Subjects with histologically confirmed locally advanced or metastatic gastric and gastroesophageal carcinoma that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy, with MET amplified (copy number gain ≥3) or MET exon 14 skipping mutation in the archival or fresh tumor tissue specimen identified in study customized targeted DNA deep sequencing (NGS by gastric cancer panel). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.

  4. Patients must have measurable disease based on RECIST 1.1 (Phase 2 part only) Measurable disease will not be required for enrollment in the phase1b part. Patients with evaluable lesion only (without measurable lesion) can be enrolled in the phase 1b part.
  5. ECOG performance status 0-1
  6. Patients must have adequate organ and marrow function as defined below:

Exclusion Criteria:

  1. Active central nervous system (CNS) lesions (ie, those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without evidence of CNS disease progression for more than 4 weeks. However, patients with a leptomeningeal metastasis are excluded.

  2. Treatment with any of the following:

    • Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
    • Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subejct can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last does.
    • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment. If acute symptoms of radiation have fully resolved, the extent and timing of radiotherapy for eligibility can be discussed between the local investigator and principal investigator.
    • Any previous exposure to a c-MET inhibitor
  3. History of allogeneic bone marrow transplantation or organ transplantation
  4. History of another primary cancer (excluding gastric cancer):

  5. Clinically significant cardiovascular disease including but not limited to:

    • Acute coronary syndome within the 6 months prior to the initiation of study drug (including myocardial infarction or unstable angina, Coronary Artery Bypass Graft surgery, percuatneous coronary intervention and stenting)
    • Current heart failure or past history of heart failure
    • Left ventricle ejection fraction (LVEF) < 50%; if there is no past history of heart failure, screening with echocardiography to confirm EF is not required.
    • Current or past history of clinically significant cardiac arrhythmia (eg, complete left bundle branch block, third degree heart block)
    • Any risk factors that prolong QTc or increase the probability of arrhythmia, including medication (eg: heart failure, hypokalemia, congenital long QT syndrome, history of Torsades de Pointes)
  6. Persistent uncontrolled hypertension as defined by: systolic >180 mmHg or diastolic >100 mmHg despite medical treatment
  7. Seropositivity of HIV or known active hepatitis B and/or active hepatitis C infection. Hepatitis B carriers may be enrolled if prophylactic use of an antiviral agent with minimal interaction with CYP3A4 is administered to inhibit HBV activation (eg. Entecavir, adefovir)
  8. Impairment of gastrointestinal function or gastrointestinal disorders (eg. untreated ulcerative disorders; uncontrolled nausea, vomiting, or diarrhea; absorption disorder syndrome; small bowel resection; ileostomy). Patients with ileostomcy will not allowed to be enrolled, but patients with colostomy can be enrolled to this study.
  9. As judged by the Investigator, all other symptoms and associated disease for which the investigator determined that participation in this study is contraindicated (e.g. Infection/inflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; unable to swallow oral pills; social and psychological problems, etc)
  10. Pregnant or lactating women. Pregnancy is defined as the state from conception confirmed by HCG clinical laboratory test to termination of pregnancy.
  11. Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial
  12. Hypersensitivity to paclitaxel
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05439993


Contacts
Layout table for location contacts
Contact: Bum Jun Kim, Dr 82-10-7140-6753 getwisdom1025@gmail.com

Locations
Layout table for location information
Korea, Republic of
Hallym University Medical Center Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Bum Jun Kim, Dr    82-10-7140-6753    getwisdom1025@gmail.com   
Sponsors and Collaborators
Hallym University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Dae Young Zang, Dr Hally University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zang, Dae Young, Professor, Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT05439993    
Other Study ID Numbers: Tepotinib in GC
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Stomach Diseases
Paclitaxel
Tepotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action