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Gastric CancerPhase 1/2NCT05400915

Two-Part, Phase Ib/II, Open Label, Single-Arm, Multi-center Study to Evaluate the Safety and Efficacy of Varlitinib in Combination With Weekly Paclitaxel in EGFR/HER2 Co-expressing Advanced or Metastatic Gastric Cancer Patients

A Phase 1/2 study testing Variltinib, Paclitaxel in people with Gastric Cancer, run by Yonsei University 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

Phase Ib part of this study determines the recommended phase II dose schedule based on ASLAN001-004 phase Ib (dose-confirmation study of Varlitinib combined with weekly paclitaxel and carboplatin or trastuzumab (Herceptin) in advanced solid tumours). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Variltinib, Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteSouth Korea
Study dates
23 Jul 2019to 13 Jun 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

  • Capable of understanding and complying with the requirements of the study and have signed the Informed Consent Form (ICF).
  • Able to communicate well with the Investigator and understand and comply with the requirements of the study.
  • Has a histologically or cytologically confirmed diagnosis of advanced or metastatic gastric adenocarcinoma (systemic metastasis or locally advanced unresectable gastric cancer). A subject must have previously received 1st line chemotherapy including fluoropyrimidine and/or platinum and have showed progression.
  • Not received paclitaxel-based chemotherapy previously.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
  • Has a measurable or evaluable disease as determined by RECIST 1.1 criteria.
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  • Able to swallow orally administered medication.
  • Life expectancy of at least 3 months
  • Has an adequate baseline organ function defined as:
  • White blood cells ≥3000/mm3 and neutrophils ≥1500/mm3
  • Platelets ≥100000/mm3
  • Hemoglobin ≥9.0 g/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN) of the study site (or ≤5.0 × ULN in patients with liver metastases)
  • Total bilirubin ≤2.0 × ULN
  • Creatinine≤1.5 × ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) >60ml/min.
  • Part 1, Phase Ib
  • 11.Subjects will be included regardless of EGFR and HER-2 Status
  • Part 2, Phase II
  • 12. Provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for central analysis of EGFR and HER2 expression status.
  • 13. Tumours with immunohistochemistry (IHC) evidence of expression of HER1 (at level of +, or ++, or +++) and HER-2 (at level of +, or ++, or +++) using standard criteria. Also, Subjects with HER-2 IHC (at level of +, or ++, or +++) and EGFR gene amplification/ mutation by NGS are included.

Who cannot join

  • Has multiple cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer, and any other cancers that have not recurred for at least 5 years)
  • Has a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed on imaging (preferably CT) or clinical findings
  • Has brain or leptomeningeal metastases. Patients may be randomized for the study if they are asymptomatic and require no treatment.
  • History of uncontrollable or significant cardiovascular disease meeting any of the following;
  • myocardial infarction within 180 days before study enrolment
  • uncontrolled angina pectoris within 180 days before study enrolment
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  • New York Heart Association (NYHA) Class III or IV congestive heart failure
  • uncontrolled hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90 mmHg lasting 24 hours or more)
  • arrhythmia requiring treatment
  • baseline corrected QT interval (Fridericia"s formula) (QTcF) > 450 ms or patients with known long QT syndrome; torsade de pointes
  • Has an active systemic infection requiring treatment.
  • Has a contraindication to paclitaxel.
  • Has undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment.
  • Subjects with malabsorption syndrome, diseases significantly affecting gastrointestinal function, has total gastrectomy, or difficulty in swallowing and retaining oral medications.
  • Has received radiotherapy for gastric cancer within 28 days before treatment or radiotherapy for bone metastases within 14 days before treatment
  • Positive test result for human immunodeficiency virus-1 (HIV-1) antibody, Hepatitis B surface protein (HBs) antigen and HBV titer>2000 IU/ml (10,000 copy/ml), or hepatitis C virus (HCV) antibody positive result
  • Any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or anemia
  • Previously treated with varlitinib
  • Unable to comply to the study protocol
  • Have participated in a study involving another investigational drug within 21 days prior to the first dose of study drug
  • Has a history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the study drug.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Yonsei Cancer Center

    Seoul

Other trials in South Korea

About this study

Phase Ib part of this study determines the recommended phase II dose schedule based on ASLAN001-004 phase Ib (dose-confirmation study of Varlitinib combined with weekly paclitaxel and carboplatin or trastuzumab (Herceptin) in advanced solid tumours). Phase II part of this study further assesses the safety and clinical efficacy of this combination treatment as a second line treatment in EGFR/HER2 co-expressing advanced or metastatic gastric cancer.

Read the detailed description

This is a two-part, Phase Ib/II, Open label, single arm, multicenter study to determine the maximum tolerated dose (MTD) and the recommended dose schedule of varlitinib in combination with paclitaxel and to further ASLAN001-017_Clinical Study Protocol Version 01_09 Oct 2018 CONFIDENTIAL 7 assess the safety and clinical efficacy of this combined treatment in EGFR/HER2 co-expressing advanced or metastatic gastric cancer after first line treatment. The objective of this trial is to allow development of an effective chemotherapeutic regimen in patients with advanced/metastatic gastric cancer with EGFR/HER-2 co-expression. This trial will also be included in second line Umbrella trial in Yonsei Cancer Center (YCC) (Figure 1).

Patients with EGFR and HER2 co-expression will be confirmed by immunohistochemistry (IHC) and NGS in a central laboratory (Yonsei Cancer Center), and those who meet all eligibility criteria will be enrolled in this study. The patients enrolled in the study will receive combined treatment with varlitinib and paclitaxel until progressive disease is confirmed or at least 1 discontinuation criterion is met (i.e development of intolerable toxicities, patient"s refusal or consent withdrawal or death). Based on previously reported study results, we arrived at an assumption that about 20-25% of screened patients will be categorized as EGFR and HER2 co-expressing gastric cancer.

Conditions
Gastric Cancer
Being tested
Variltinib, Paclitaxel
Keywords
EGFR/HER2 Co-expressing gastric cancer, Varlitinib
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Variltinib, PaclitaxelDrug

    Varlitinib will be administered orally to the study participants at doses 300mg, BID in combination with the weekly intravenous infusion of Paclitaxel for 3 weeks with a rest period of 1 week.

Study groups in NCT05400915
Study groupRoleWhat they receive
Variltinib, PaclitaxelExperimentalNot described
Receives: Drug: Variltinib, Paclitaxel

What is being measured

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

  1. (Phase Ib) Maximum Tolerated dose

    Measured: 3 years

  2. (Phase Ib) Dose limiting Toxicity

    Measured: 3 years

  3. (Phase II) Progression-free survival

    Progression-free survival (PFS): Defined as the time from start of study treatment until the date of objective disease progression or death (by any cause in the absence of disease progression) Progression is defined in accordance with the RECIST v1.1 criteria.

    Measured: 3 years

Secondary outcomes (5)

  1. Overall Survival

    Overall Survival (OS): Defined as the time from start of study treatment until death by any cause. Any subject not known to have died at the time of the analysis will be censored based on the last recorded date on which the subject was known to be alive.

    Measured: 3 years

  2. Objective Response Rate

    Objective Response Rate (ORR)- Objective response rate is defined as the number (%) of patients with at least one confirmed visit response of CR or PR.

    Measured: 3 years

  3. Disease Control Rate

    Disease Control Rate (DCR): Defined as the proportion of subjects with a best objective response (BOR) of complete response (CR) or partial response (PR), or stable disease maintained for a minimum of twelve weeks (± 5 days) from start of treatment, as defined by the RECIST v1.1 criteria.

    Measured: 3 years

  4. Progression-free survival

    Progression-free survival (PFS): Defined as the time from start of study treatment until the date of objective disease progression or death (by any cause in the absence of disease progression) Progression is defined in accordance with the RECIST v1.1 criteria. Determination of PFS rate at 24 weeks.

    Measured: 3 years

  5. Number of Participants With Adverse Events That Are Related to Treatment

    Safety and tolerability of the Varlitinib and Paclitaxel combination therapy as determined by adverse events categorized in accordance with CTCAE 4.03 Criteria.

    Measured: 3 years

Timeline

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

  1. First posted2 Jun 2022
  2. Study start23 Jul 2019
  3. Primary completion13 Dec 2021
  4. Study completion13 Jun 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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400915
Sponsor's protocol ID
4-2018-1011
Status last verified
Nov 2023
First submitted
18 May 2022
Last updated
13 Nov 2023
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 Variltinib, Paclitaxel in people with Gastric Cancer, run by Yonsei University 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 20 inclusion and 21 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 13 Nov 2023. 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 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?

(Phase Ib) Maximum Tolerated dose (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT05400915.

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 13 Nov 2023.

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