Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

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)

AMG 337

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).

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.

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

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

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Adverse events and clinical laboratory abnormalities defined as DLTs.

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

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).

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

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.

Amgen

Amino Acids

All Drugs and Chemicals

Tyrosine

AMG 337 is a small molecule inhibitor of c-Met which is a receptor tyrosine kinase expressed on the surface of epithelial cells.

First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.

A Study of AMG 337 in Subjects With Advanced Solid Tumors

A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects With Advanced Solid Tumors

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Methotrexate

Pyrazole

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

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)

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.

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.

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

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

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

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

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

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

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

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

NantPharma, LLC

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

This is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of AMG 337 in MET amplified Gastric/esophageal adenocarcinoma or other solid tumors. Approximately 140 subjects will be enrolled to either Cohort 1 (subjects with MET amplified G/E adenocarcinoma with measurable tumor) or Cohort 2 (subjects with MET amplified solid tumors with measurable tumor/up to 10 subjects with MET amplified G/E adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior MET antibody therapy). All subjects will self-administer AMG 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met.

Tumor tissue, biomarkers, Pharmacokinetics and Patient reported Outcomes will all be assessed.

Tumor assessment by RECIST 1.1 will be followed during study treatment.

Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors

A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors

To evaluate the impact of AMG 337 on health-related quality of life (HRQoL) in subjects with MET amplified G/GEJ/E adenocarcinoma (Cohort 1 only).

assessed at baseline. Circulating tumor cells (CTC) and circulating serum biomarkers will also be assessed at baseline and during study treatment

To analyse tumor DNA samples for MET pathway-related genes (and other genes based on emerging data) that may predict response to AMG 337

Explore whether the level of MET amplification, expression, or presence of mutation in tumor specimens correlates with response to AMG 337.

Determine antitumor activity of AMG 337 in subjects with MET amplified G/GEJ/E adenocarcinoma

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

Determine antitumor activity of AMG 337 in subjects with other MET amplified solid tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects	NCT02096666	Stomach Neoplas...	AMG 337	20 Years -	Amgen
A Study of AMG 337 in Subjects With Advanced Solid Tumors	NCT01253707	Advanced Malign... Advanced Solid ... Cancer Oncology Oncology Patien... Tumors	AMG 337	18 Years -	Amgen
QUILT-3.036: AMG 337 in Subjects With Advanced or Metastatic Solid Tumors	NCT03147976	Solid Tumor	AMG 337	16 Years -	NantPharma, LLC
Phase 2 Study of AMG 337 in MET Amplified Gastric/Esophageal Adenocarcinoma or Other Solid Tumors	NCT02016534	Stomach Neoplas...	AMG 337	18 Years -	Amgen

Spots Global Cancer Trial Database for amg 337

Every month we try and update this database with for amg 337 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for amg 337

Every month we try and update this database with for amg 337 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for amg 337 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.