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TEW-7197 With Paclitaxel for the Treatment of Metastatic Gastric Cancer

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: NCT03698825
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
MedPacto, Inc.

Brief Summary:
This is an open-label, single arm study evaluating the safety and tolerability of TEW-7197 in combination with paclitaxel in metastatic gastric cancer patients.

Condition or disease Intervention/treatment Phase
Metastatic Gastric Cancer Drug: TEW-7197 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase Ib/2a Study of TEW-7197 (Vactosertib) Plus Weekly Paclitaxel as Second-line Treatment for Metastatic Gastric Adenocarcinoma
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : June 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Dose Escalation of TEW-7197
TEW-7191 will be given twice daily (BID) for 5 days followed by 2 days off with a cycle of 4 weeks
Drug: TEW-7197
TEW-7197 50mg tablets + Paclitaxel 80 mg/m2 D1, 8, 15 q 4 weeks TEW-7197 dose will be determined through this dose escalation study
Other Name: vactosertib




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks ]
    To define the MTD and determine RP2D


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events assessed by NCI CTCAE v5.0 [ Time Frame: from screening through study completion (up to 28 days after the last dose of TEW-7197), an average of 1 year. ]
    To evaluate safety profile of TEW-7197 with regards to frequency, type, grade, and seriousness, and causality of treatment-related clinical and laboratory adverse events including, but not limited to, AST, ALT, total bilirubin, serum creatinine, etc.

  2. Overall survival [ Time Frame: every 2 cycles (8 weeks) and end-of-treatment (EOT) time point. EOT is defined as within 7 days from the last dose of study medication by the protocol. ]
    Overall survival (months, median) defined by RECIST 1.1

  3. Objective response [ Time Frame: every 2 cycles (8 weeks) and end-of-treatment (EOT) time point. EOT is defined as within 7 days from the last dose of study medication by the protocol. ]
    Objective response rate (%) defined by RECIST 1.1

  4. pharmacokinetics of TEW-7197 [ Time Frame: At cycle 1 (each cycle is 28 days) ]
    Peak Plasma Concentration (Cmax) of TEW-7197

  5. pharmacokinetics of TEW-7197 [ Time Frame: At cycle 1 (each cycle is 28 days) ]
    Area under the plasma concentration versus time curve (AUC) of TEW-7197


Other Outcome Measures:
  1. pSMAD as a pharmacodynamic marker [ Time Frame: At baseline and cycle 1 (each cycle is 28 days) ]
    pSMAD in peripheral blood mononuclear cell determined by immunohistochemistry



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic gastric adenocarcinoma
  • ECOG Performance Status <2
  • Patients who have disease progression after treatment with all available therapies including fluoropyrimidine and oxaliplatin or trastuzumab in case HER2 positive.
  • Confirmation of measurable disease based on RECIST 1.1 by investigators at Screening
  • Patients who meet below laboratory inclusion criteria Bilirubin< 1.5xULN (upper limit of normal) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3xULN (<5xULN in case of hepatic metastasis) Serum creatinine < 1.5xULN Absolute neutrophil count 1,000 cells/µL or more Platelet count 80,000/µL or more Hemoglobin count 9.0 g/dL or more
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

  • Patients who have received total gastrectomy
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy
  • Has received systemic anti-cancer therapy within 2 weeks prior to screening
  • Has received major surgical procedure or radiation therapy within 4 weeks prior to screening
  • Has received investigational agents for the cancer therapy and has not passed at least 5 times of the half life of the agents.
  • Previous treatment of paclitaxel or any agents targeting TGF-β signaling pathway
  • Unable to swallow tablets
  • Known CNS metastases and/or leptomeningeal involvement
  • Has additional concurrent malignancy or has diagnosed another malignancy within 3 years prior to screening excluding basal cell carcinoma, papillary thyroid cancer, or carcinoma in situ
  • Uncontrolled congestive heart failure or myocardial infarction
  • A women of childbearing potential (WOCBP) who has a positive urine pregnancy test, and male or female patients of reproductive potential who are not willing to employ effective birth control during the intervention and safety follow up period
  • Child-Pugh B or C
  • Judgment by the Investigator that the patient should not participate in the study

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): NCT03698825


Contacts
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Contact: Insun Baek +82-70-8610-2727 insun.baek@medpacto.com

Locations
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Korea, Republic of
Yonsei University Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
MedPacto, Inc.
Investigators
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Study Director: Sunjin Hwang, MD MedPacto, Inc.
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Responsible Party: MedPacto, Inc.
ClinicalTrials.gov Identifier: NCT03698825    
Other Study ID Numbers: MP-GC-01
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases