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Solid TumorPhase 2NCT03147976

QUILT-3.036: AMG 337 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 2 study testing AMG 337 in people with Solid Tumor, run by NantPharma, LLC at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 2 study of AMG 337 in subjects with advanced or metastatic solid tumors that overexpress MET or harbor METex14del mutations resulting in MET exon 14 skipping. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Solid Tumor
What is being tested?
AMG 337
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
2 May 2018to 23 Aug 2019
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
  • Able to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Able to self-administer AMG 337 as a whole capsule by mouth every day.
  • Age ≥ 16 years old.
  • Histologically confirmed, unresectable locally advanced or metastatic solid tumor that overexpresses tumor MET (determined by quantitative proteomics with mass spectrometry [cohort 1]) or harbor METex14del mutations resulting in MET exon 14 skipping (as determined by DNA sequencing and confirmed with RNA sequencing [cohort 2]).
  • Have measurable disease evaluable in accordance with RECIST Version 1.1.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Must have a recent formalin-fixed paraffin-embedded (FFPE) tumor biopsy specimen that was obtained following the conclusion of the most recent anticancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
  • Must be willing to undergo a biopsy during the treatment period, if considered safe by the investigator.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Hematologic function, as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
  • Platelet count ≥ 50 × 10^9/L.
  • Hemoglobin > 8 g/dL.
  • Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 × upper limit of normal (ULN), except for subjects on anticoagulation therapy for venous thromboembolism.
  • Renal function, as follows:
  • Calculated creatinine clearance > 30 mL/min.
  • Hepatic function, as follows:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN and total bilirubin < 1.5 × ULN.
  • Alkaline phosphatase (ALP) < 2 × ULN (≤ 5 × ULN if bone or liver metastases are present).
  • Agreement to practice effective contraception (both male and female subjects, if the risk of conception exists).

Who cannot join

  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Inability to attend required study visits and return for adequate follow-up, as required for this protocol.
  • Known hypersensitivity to any component of the study medication(s).
  • Women who are nursing, pregnant, or planning to become pregnant during the duration of the study.
  • Current diagnosis of sporadic or hereditary renal cell carcinoma.
  • Current diagnosis or history of a second neoplasm, except the following:
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  • Adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
  • Subjects with tumors with ALK-positive rearrangement who received prior treatment with crizotinib.
  • History of bleeding diathesis.
  • Uncontrolled hypertension (systolic > 160 mmHg and/or diastolic > 100 mmHg) or clinically significant cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months before study day 1; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
  • Baseline ECG Fridericia's formula (QTcF) > 470 ms.
  • Active infection requiring IV antibiotics within 2 weeks before study day 1.
  • Significant gastrointestinal disorder (eg, Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that in the opinion of the investigator may influence drug absorption.
  • Positive result of screening test for human immunodeficiency virus (HIV).
  • Evidence of acute hepatitis B and C. Subjects with chronic hepatitis B or C are eligible if their condition is stable and, in the opinion of the investigator, would not pose a risk to subject safety.
  • Toxicities from prior anti-tumor therapy not resolved to CTCAE Version 4.03 grade 0 or 1.
  • Grade 2 toxicities from prior antitumor therapy that are considered irreversible (defined as having been present or stable for > 4 weeks), such as stable grade 2 peripheral neuropathy or ifosfamide-related proteinuria, may be allowed if they are not otherwise described in the exclusion criteria.
  • Participation in this study or in an investigational study and/or procedure with any molecularly targeted agents reported to inhibit MET within 14 days before study day 1.
  • Antitumor therapy, including chemotherapy, antibody therapy, retinoid therapy, or other investigational therapy, within 14 days before study day 1.
  • Therapeutic or palliative radiation therapy within 14 days before study day 1.
  • Major surgery within 28 days before study day 1.
  • Any comorbidity that in the opinion of the investigator may increase the risk of toxicity.
  • Concurrent or prior use of a strong CYP3A4 inhibitor within 14 days before study day 1, including the following: ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole.
  • Concurrent or prior ingestion of grapefruit, grapefruit products, or other foods known to inhibit CYP3A4 within 7 days before study day 1.
  • Concurrent or prior use of strong CYP3A4 inducers within 28 days before study day 1, including the following: phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and the herbal supplement St. John's Wort.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

Other trials in United States

About this study

Official title: A Phase 2 Study of AMG 337 in Subjects With Advanced or Metastatic Solid Tumors That Overexpress Mesenchymal Epithelial Transition (MET) or Harbor MET Exon 14 Skipping (METex14del) Mutations

This is a phase 2 study of AMG 337 in subjects with advanced or metastatic solid tumors that overexpress MET or harbor METex14del mutations resulting in MET exon 14 skipping.

Read the detailed description

This is a phase 2, two-cohort, single-arm open-label study that will assess the efficacy of AMG 337 based on ORR in subjects with advanced or metastatic solid tumors that overexpress MET or harbor METex14del mutations resulting in MET exon 14 skipping. MET overexpression will be determined by quantitative proteomics with mass spectrometry. METex14del mutations resulting in MET exon 14 skipping will be determined by DNA sequencing and confirmed with RNA sequencing. Subjects will be enrolled as follows:

  • Cohort 1: Subjects with advanced or metastatic solid tumors that overexpress MET
  • Cohort 2: Subjects with advanced or metastatic solid tumors that harbor METex14del mutations Simon's two-stage optimal design will be utilized separately for each cohort to assess the primary efficacy endpoint ORR. The null hypothesis of Simon's two-stage design states that the ORR will be ≤ 10% (poor response) and will be tested against a one-sided alternative.
Conditions
Solid Tumor
Being tested
AMG 337

What participants receive

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

  • AMG 337Drug

    6-{(1R)-1-[8-fluoro-6-(1-methyl-1H-pyrazol-4- yl)[1,2,4]triazolo[4,3-a]pyridin-3-yl]ethyl}-3-(2- methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)

Study groups in NCT03147976
Study groupRoleWhat they receive
AMG 337ExperimentalAMG 337 in subjects with advanced or metastatic solid tumors that overexpress MET or harbor METex14del mutations
Receives: Drug: AMG 337

What is being measured

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

  1. Objective Response Rate (ORR)

    Confirmed ORR (confirmed complete response (CR) or partial response (PR)) will be evaluated in accordance with RECIST Version 1.1.

    Measured: 1 year

Secondary outcomes (5)

  1. Incidence of Treatment-Emergent Adverse Events (Safety And Tolerability)

    To evaluate the safety of AMG 337 based on grade 3 or 4 non-hematologic toxicity

    Measured: 1 year

  2. Progression-free Survival (PFS)

    To determine PFS, evaluated in accordance with RECIST Version 1.1.

    Measured: 1 year

  3. Overall Survival (OS)

    To determine OS, defined as the time from the date of the first administration of therapy to the date of death.

    Measured: 1 year

  4. Duration of Response (DOR)

    To determine the duration of response, measured by RECIST Version 1.1.

    Measured: 1 year

  5. Disease Control Rate (DCR)

    To determine disease control rate (confirmed CR, PR, or stable disease [SD]) lasting for at least 4 months.

    Measured: 4 months

Timeline

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

  1. First posted10 May 2017
  2. Study start2 May 2018
  3. Primary completion23 Aug 2019
  4. Study completion23 Aug 2019

Why it stopped: Enrollment not initiated

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147976
Sponsor's protocol ID
QUILT-3.036
Status last verified
Aug 2018
First submitted
8 May 2017
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 337 in people with Solid Tumor, run by NantPharma, LLC at 1 site in United States.

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 21 inclusion and 25 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: withdrawn, as of the sponsor's last update on 28 Aug 2019. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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) (time frame: 1 year). 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 NCT03147976.

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 Aug 2019.

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