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

Primary Purpose

Metastatic Gastric Cancer

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TEW-7197

About this trial

This is an interventional treatment trial for Metastatic Gastric Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Hallym University Medical Center
Hwasun Chunnam university hospital
Chung-Ang University hospital
Gangbuk Samsung Medical Center
Gangnam Severance
Shinchon Severance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation of TEW-7197

Arm Description

TEW-7191 will be given twice daily (BID) for 5 days followed by 2 days off with a cycle of 4 weeks

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)

To define the MTD and determine RP2D

Secondary Outcome Measures

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

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.

Overall survival

Overall survival (months, median) defined by RECIST 1.1

Objective response

Objective response rate (%) defined by RECIST 1.1

pharmacokinetics of TEW-7197

Peak Plasma Concentration (Cmax) of TEW-7197 Area under the plasma concentration versus time curve (AUC) of TEW-7197

Full Information

NCT ID

NCT03698825

First Posted

September 27, 2018

Last Updated

March 17, 2021

Sponsor

MedPacto, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03698825

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 15, 2018 (Actual)

Primary Completion Date

December 20, 2021 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedPacto, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

In the dose escalation step (phase 1b), 3 subjects are registered for each dose step, and the DLT is evaluated by administering the investigational product for 1 cycle (28 days). However, for reasons other than toxicity related to the test drug, the patient was given a combination of Paclitaxel and TEW-7197 (Vactosertib) during the DLT evaluation period during the first cycle of the planned TEW-7197. If more than 80% of the administered dose of (Vactosertib) is not administered, the patient will be considered unevaluable for DLT and another patient will be enrolled. At the end of one cycle of each cohort, the SMC decides whether to proceed to the next cohort. After completing the DLT evaluation of the final phase 1 cohort, the recommended dose to proceed in the dose expansion phase (Phase 2a) is determined. For subjects who have completed one cycle (DLT evaluation period), administer the investigational drug at the same dose until disease progression or unacceptable toxicity occurs. Tumor imaging (CT or MRI) for tumor evaluation is performed after screening and C1D1. Assessment every 6 weeks (±2 weeks) and at the end of treatment (EOT/DC). As efficacy evaluation items, PFS, OS, ORR, and DCR are evaluated according to RECIST 1.1, and the amount of change in the biomarker is confirmed. In the dose expansion phase (phase 2a), 50 patients will be enrolled at the dose determined in the dose escalation phase. Tumor imaging (CT or MRI) for tumor evaluation is evaluated every 6 weeks (±2 weeks) after screening and C1D1, and at the end of treatment (EOT/DC). As validity evaluation items, PFS, OS, ORR, and DCR according to RECIST 1.1 are evaluated, and the amount of change in the biomarker is confirmed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation of TEW-7197

Arm Type

Experimental

Arm Description

TEW-7191 will be given twice daily (BID) for 5 days followed by 2 days off with a cycle of 4 weeks

Intervention Type

Drug

Intervention Name(s)

TEW-7197

Other Intervention Name(s)

vactosertib

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose (MTD)

Description

To define the MTD and determine RP2D

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Overall survival

Description

Overall survival (months, median) defined by RECIST 1.1

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.

Title

Objective response

Description

Objective response rate (%) defined by RECIST 1.1

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.

Title

pharmacokinetics of TEW-7197

Description

Peak Plasma Concentration (Cmax) of TEW-7197 Area under the plasma concentration versus time curve (AUC) of TEW-7197

Time Frame

At cycle 1 (each cycle is 28 days)

Other Pre-specified Outcome Measures:

Title

pSMAD as a pharmacodynamic marker

Description

pSMAD in peripheral blood mononuclear cell determined by immunohistochemistry

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sunjin Hwang, MD

Organizational Affiliation

MedPacto, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Hallym University Medical Center

City

Anyang-si

Country

Korea, Republic of

Facility Name

Hwasun Chunnam university hospital

City

Hwasun

Country

Korea, Republic of

Facility Name

Chung-Ang University hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Gangbuk Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Gangnam Severance

City

Seoul

Country

Korea, Republic of

Facility Name

Shinchon Severance

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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