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Metastatic Gastric CancerPhase 1/2NCT03698825

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

A Phase 1/2 study testing TEW-7197 in people with Metastatic Gastric Cancer, run by MedPacto, Inc. at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Metastatic Gastric Cancer
What is being tested?
TEW-7197
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
6 sitesSouth Korea
Study dates
15 Aug 2018to 28 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Hallym University Medical Center

    Anyang-si

  • Hwasun Chunnam university hospital

    Hwasun

  • Chung-Ang University hospital

    Seoul

  • Gangbuk Samsung Medical Center

    Seoul

  • Gangnam Severance

    Seoul

  • Shinchon Severance

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
TEW-7197
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEW-7197Drug

    Also called vactosertib

    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

Study groups in NCT03698825
Study groupRoleWhat they receive
Dose Escalation of TEW-7197ExperimentalTEW-7191 will be given twice daily (BID) for 5 days followed by 2 days off with a cycle of 4 weeks
Receives: Drug: TEW-7197

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    To define the MTD and determine RP2D

    Measured: 4 weeks

Secondary outcomes (4)

  1. 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.

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

  2. Overall survival

    Overall survival (months, median) defined by RECIST 1.1

    Measured: 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.

  3. Objective response

    Objective response rate (%) defined by RECIST 1.1

    Measured: 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.

  4. pharmacokinetics of TEW-7197

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

    Measured: At cycle 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start15 Aug 2018
  3. Primary completion3 Jan 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698825
Sponsor's protocol ID
MP-GC-01
Status last verified
Dec 2024
First submitted
27 Sep 2018
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TEW-7197 in people with Metastatic Gastric Cancer, run by MedPacto, Inc. at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03698825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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