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Stomach NeoplasmsPhase 1/2NCT02096666

A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects

A Phase 1/2 study testing AMG 337 in people with Stomach Neoplasms, run by Amgen at 4 sites in Japan.

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 a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
AMG 337
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
4 sitesJapan
Study dates
15 Apr 2014to 7 Dec 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to self administer daily AMG 337 as a whole capsule
  • Male or female 20 years of age or over
  • Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard therapy exists, or the subject refuses standard therapy.
  • Phase 2: Subjects must have a pathologically confirmed, advanced G/GEJ/E adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which the subjects have received prior therapy for advanced disease, or for which no standard therapy exists, or the subject refuses standard therapy.
  • Tumor MET amplified by protocol-specified centralized testing (phase 2 only).
  • Phase 1: Measurable or non-measurable disease per RECIST v1.1
Show all 9Show fewer
  • Phase 2: Measurable disease per RECIST v1.1 guidelines. Cohort 2 may include subjects with advanced MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor per RECIST v1.1.
  • (ECOG) Performance Status of 0, 1, or 2
  • Other protocol defined inclusion criteria may apply.

Who cannot join

  • Known central nervous system metastases.
  • Subject is a candidate for curative surgery or definitive chemoradiation.
  • Peripheral edema > grade 1.
  • Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. Significant gastrointestinal disorder(s) that in the opinion of the Investigator may influence drug absorption.
  • Currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment.
  • Prior treatment with small molecule inhibitors of the MET pathway.
  • Other protocol defined exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Research Site

    Kashiwa-shi, Chiba, 277-8577

  • Research Site

    Kawasaki-shi, Kanagawa, 216-8511

  • Research Site

    Sapporo, Hokkaido, 060-8648

  • Research Site

    Suntou-gun, Shizuoka, 411-8777

Other trials in Japan

About this study

Official title: A Multicenter, Phase 1/2, Open-Label Study Evaluating the Tolerability, Safety, Pharmacokinetics, and Efficacy of AMG 337 in Asian Subjects

This is a multicenter, Phase 1/2 study. The study will evaluate the tolerability, safety and activity of AMG 337 in Asian subjects who have advanced solid tumors (Phase 1) or subjects with MET amplified tumors with a focus on gastric/gastroesophageal junction/esophageal adenocarcinoma (Phase 2).

Read the detailed description

This is a Phase 1/2, multicenter, single arm, open-label study to assess the safety, efficacy and pharmacokinetics of AMG 337 in solid tumors. In the Phase 1, approximately 3 to 45 subjects enrolled in a 3+3+3 dose escalation scheme evaluating two dose levels. In the Phase 2, approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified /gastroesophageal junction/esophageal (G/GEJ/E) adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor and subjects with MET amplified G/GEJ/E adenocarcinoma with non-measurable tumor). All subjects will self-administer AMG 337 daily until disease progression or other protocol specified end of treatment criteria are met. Tumor assessment by RECIST 1.1 will be followed during study treatment.

Tumor tissue, biomarkers, pharmacokinetics and Patient Reported Outcomes will be assessed.

Being tested
AMG 337
Keywords
MET Amplified Gastric/ Gastroesophageal Junction/ Esophageal Adenocarcinomas, or other solid tumors
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • AMG 337Drug

    Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1)

Study groups in NCT02096666
Study groupRoleWhat they receive
Single armExperimentalNot described
Receives: Drug: AMG 337

What is being measured

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

  1. Phase 1- Adverse events and clinical laboratory abnormalities

    Adverse events and clinical laboratory abnormalities defined as DLTs.

    Measured: 17 months

  2. Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)

    Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)

    Measured: 17 months

Secondary outcomes (15)

  1. Phase 1- Pharmacokinetic parameters

    Including, but not limited to, minimum (trough) concentrations, maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC).

    Measured: 17 months

  2. Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters

    Measured: 17 months

  3. Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2)

    Determine anti-tumor activity in AMG 337 in subjects with MET amplified solid tumors (subjects with measurable disease in cohort 2)

    Measured: 17 months

  4. Phase 2- Duration of Response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

    Measured: 17 months

  5. Phase 2- Time to response (cohort 1 and subjects with measurable disease at baseline in cohort 2)

    Measured: 17 months

  6. Phase 2- Progression Free Survival

    Measured: 17 months

  7. Phase 2- Overall Survival

    Measured: 17 months

  8. Phase 2- Incidence and severity of adverse events and significant laboratory abnormalities

    Measured: 17 months

  9. Phase 2- AMG 337 exposure and dose intensity

    Measured: 17 months

  10. Phase 2- Pharmacokinetic parameters

    Including, but not limited to, minimum (trough) concentrations at pre-dose times and maximum concentrations (C max), the time of C max (t max), and area under the plasma concentration- time curve (AUC) for intensive pharmacokinetic sampling.

    Measured: 17 months

  11. Phase 1- Overall Response Rate

    Measured: 17 months

  12. Phase 1- Duration of Response

    Measured: 17 months

  13. Phase 1- Time to Response

    Measured: 17 months

  14. Phase 1- Progression-Free Survival (per RECIST v1.1)

    Measured: 17 months

  15. Phase 1- Overall Survival

    Measured: 17 months

Timeline

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

  1. First posted26 Mar 2014 (estimated)
  2. Study start15 Apr 2014
  3. Primary completion5 Nov 2015
  4. Study completion7 Dec 2018

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02096666
Sponsor's protocol ID
20120370
Status last verified
Dec 2021
First submitted
24 Mar 2014
Last updated
28 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

  • Yasui H, Go N, Yang H, Amore BM, Jung AS, Doi T. A Phase 1 study evaluating AMG 337 in Asian patients with advanced solid tumors. Jpn J Clin Oncol. 2017 Aug 1;47(8):772-776. doi: 10.1093/jjco/hyx067.

    PubMed 28582510

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 337 in people with Stomach Neoplasms, run by Amgen at 4 sites in Japan.

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 9 inclusion and 7 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 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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 1- Adverse events and clinical laboratory abnormalities (time frame: 17 months). The study lists 2 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 NCT02096666, 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 28 Dec 2021.

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