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

NCT03147976 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: QUILT-3.036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (5)

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

  1 year

• Progression-free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

• Duration of Response (DOR)

  1 year

• Disease Control Rate (DCR)

  4 months

Study Arms (1)

AMG 337

EXPERIMENTAL

AMG 337 in subjects with advanced or metastatic solid tumors that overexpress MET or harbor METex14del mutations

Drug: AMG 337

Interventions

AMG 337 DRUG

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)

AMG 337

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• a. 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.

Sponsors & Collaborators

• NantPharma, LLC: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Interventions

AMG 337

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 2, 2018
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: August 28, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)