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

NCT03698825 | Completed Phase 1 DMC

• 1 other identifier: MP-GC-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

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.

Conditions

Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  To define the MTD and determine RP2D

  4 weeks

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events assessed by NCI CTCAE v5.0

  from screening through study completion (up to 28 days after the last dose of TEW-7197), an average of 1 year.

• Overall survival

  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

  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.

• pharmacokinetics of TEW-7197

  At cycle 1 (each cycle is 28 days)

Other Outcomes (1)

• pSMAD as a pharmacodynamic marker

  At baseline and cycle 1 (each cycle is 28 days)

Study Arms (1)

Dose Escalation of TEW-7197

EXPERIMENTAL

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

Interventions

TEW-7197 DRUG

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

Also known as: vactosertib

Dose Escalation of TEW-7197

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 19 years of age
• Patients diagnosed with histologically or cytologically metastatic gastric cancer
• Patients corresponding to ECOG Performance Status 0
• The 5-Fluorouracil family (5-Fluorouracil) is the primary treatment for metastatic gastric cancer.
• Patients who received additional Trastuzumab coalescing therapy for Cisplatin (Oxaliplatin) and Platinum (Oxaliplatin) or HER2-positive.
• Patients with evalable lesions according to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
• Patients with the following laboratory test values during screening:
• Bilirubin is not more than 1.5 times the upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) not more than 3 times ULN (if liver metastasis, not more than 5 times ULN)
• Serum cretin is not more than 1.5 times the ULN
• Absolute neutrophil count (ANC)가 1,000 cells/µL 이상
• Platelet count is over 80,000/µL
• Hemoglobin count 가 9.0 g/dL 이상
• Patients who voluntarily agreed to participate in the clinical trial after hearing the explanation of this clinical trial.

You may not qualify if:

• Patients with unresolved chronic toxicity of CTC grade 2 or higher in previous chemotherapy
• Patients who have received chemotherapy or chemotherapy within two weeks prior to screening
• Patients who have undergone major surgery or radiation treatment within four weeks prior to screening
• Patients who have received medication for other clinical trials before screening and have less than 5 times the period of this half-life. Patients who are less than two weeks from the date of final administration if the half-life of the previous clinical trial drug is not clear.
• Patients previously treated with paclitaxel
• Patients who previously received treatment targeting the TGF-£ signaling pathway
• Patients who cannot take tablets
• Patients who are neurologically unstable due to overall metastasis in the central nervous system or who have increased the amount of steroid to alleviate the central nervous system signs within two weeks before screening.
• If another type of tumor is present, or within three years prior to screening, another tumor is present.
• diagnosed patients (except for single basal cell carcinoma, thyroid cancer and cervical cancer-insitu)
• Patients with a history of congestive heart failure or myocardial infarction that is not controlled by medication
• Pregnant women who are positive for pregnancy test results in this clinical trial and contraception by themselves and their partners during the safety follow-up period after treatment (e.g., infertility surgery, intrauterine, oral contraceptives, liver wall contraception, and other hormone delivery systems, creams, jellies, etc.)
• Patients with evidence of cirrhosis above Child-Pugh B or C. For HBV or HCV-linked chronic hepatitis or cirrhosis Child-Pugh A, it can be registered for clinical trials if the liver function is reliably maintained through medication.
• Other patients who are deemed unfit to participate in the study

Sponsors & Collaborators

• MedPacto, Inc.: lead

Study Sites (6)

Hallym University Medical Center

Anyang-si, South Korea

Location

Hwasun Chunnam university hospital

Hwasun, South Korea

Location

Chung-Ang University hospital

Seoul, South Korea

Location

Gangbuk Samsung Medical Center

Seoul, South Korea

Location

Gangnam Severance

Seoul, South Korea

Location

Shinchon Severance

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

vactosertib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Sunjin Hwang, MD

  MedPacto, Inc.

  STUDY DIRECTOR

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: September 27, 2018
• First Posted: October 9, 2018
• Study Start: August 15, 2018
• Primary Completion: January 3, 2022
• Study Completion: December 28, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)