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Stomach NeoplasmsPhase 2NCT03052478

Study of Vismodegib in Advanced Gastric Adenocarcinoma Patients With SMO Overexpression

A Phase 2 study testing Vismodegib 150 mg in people with Stomach Neoplasms, run by Samsung Medical Center at 1 site 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

There is no accepted standard therapy for patients with advanced gastric cancer who have progressed during or after second-line therapy. The role of 3rd line treatment in advanced gastric cancer has not been proven. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
Vismodegib 150 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
10 Feb 2017to 10 Sep 2020
Phase
Phase 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of fully informed consent prior to any study specific procedures.
  • Patients must be ≥20 years of age.
  • Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after 1st line or second-line therapy.
  • Both fluoropyrimidine and platinum agent need to be contained in the prior chemotherapies
  • Prior adjuvant or neoadjuvant therapy is counted as 1 regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy.
  • Acceptable prior chemotherapy regimens for this protocol are chemotherapy regimens that include Immune Target agent therapy. (such as a pembrolizumab, ramucirumab etc)
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  • Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Patients with SMO overexpression by IHC
  • Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  • ECOG performance status 0-1.
  • Patients must have a life expectancy ≥ 3 months from proposed first dose date.
  • Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
  • Haemoglobin ≥9.0 g/dL (transfusion allowed)
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • White blood cells (WBC) > 3 x 109/L
  • Platelet count ≥100 x 109/L (transfusion allowed)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (does not include patients with Glibert's disease)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
  • Serum creatinine ≤1.5 x institutional ULN
  • Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. for women of childbearing potential.
  • Provision of consent for mandatory biopsy at progression (fresh frozen will be mandatory if clinically feasible)
  • Provision of archival or fresh tissue sample at baseline (fresh frozen will be mandatory if clinically feasible)

Who cannot join

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Any previous treatment with Hedgehog pathway inhibitor
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  • HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
  • Patients unable to swallow orally administered medication.
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  • Treatment with any investigational product during the last 21 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
  • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denusomab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
  • With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
  • Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
  • Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  • Patients with cardiac problem as follows: Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment
  • Female patients who are breast-feeding or child-bearing and Male or female patients of reproductive potential who are not employing an effective method of contraception
  • Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) (HBV carrier is allowed)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, Seoul, 135710

Other trials in South Korea

About this study

Official title: Phase II, Single-arm Study of Vismodegib in Advanced Gastric Adenocarcinoma Patients With SMO Overexpression

There is no accepted standard therapy for patients with advanced gastric cancer who have progressed during or after second-line therapy. The role of 3rd line treatment in advanced gastric cancer has not been proven.

As a novel target of gastric cancer, SMO overexpression is chosen in this study, and the investigators plan this study to evaluate the efficacy and safety of vismodegib in gastric cancer. The doses of vismodegib are based on trials of basal cell carcinoma.

Being tested
Vismodegib 150 mg
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Vismodegib 150 mgDrug

    Vismodegib 150 mg will be administered orally once a day for 21 days as one cycle.

Study groups in NCT03052478
Study groupRoleWhat they receive
vismodegib armExperimental. Vismodegib 150 mg will be administered orally once a day for 21 days as one cycle.
Receives: Drug: Vismodegib 150 mg

What is being measured

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

  1. Objective response rate (ORR) by RECIST 1.1

    Measured: 6 months

Timeline

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

  1. First posted14 Feb 2017
  2. Study start10 Feb 2017
  3. Primary completion31 Dec 2019
  4. Study completion10 Sep 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052478
Sponsor's protocol ID
2016-08-130
Status last verified
Jun 2021
First submitted
10 Feb 2017
Last updated
8 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kim R, Ji JH, Kim JH, Hong JY, Lim HY, Kang WK, Lee J, Kim ST. Safety and anti-tumor effects of vismodegib in patients with refractory advanced gastric cancer: A single-arm, phase-II trial. J Cancer. 2022 Jan 9;13(4):1097-1102. doi: 10.7150/jca.67050. eCollection 2022.

    PubMed 35281856

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vismodegib 150 mg in people with Stomach Neoplasms, run by Samsung Medical Center at 1 site 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 22 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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?

Objective response rate (ORR) by RECIST 1.1 (time frame: 6 months). 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 NCT03052478, which also lists 1 linked publication.

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 8 Jun 2021.

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