AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP)

A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.

The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Advanced MTAP-null Solid Tumors
• Intervention / Treatment: Drug: AMG 193; Drug: Docetaxel; Drug: Comparator AMG 193 Test Tablet

• Study Type: Interventional
• Enrollment (Estimated): 527
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris OBrien Lifehouse
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universitaet Graz
  • Salzburg, Austria, 5020
    • Recruiting
    • Landeskrankenhaus Salzburg
• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Edegem, Belgium, 2650
    • Recruiting
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis - Campus Virga Jesse
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Cross Cancer Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
• France
  • Dijon cedex, France, 21079
    • Recruiting
    • Centre Georges Francois Leclerc
  • Lille, France, 59000
    • Recruiting
    • Centre Oscar Lambret
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
• Germany
  • Halle (Saale), Germany, 06120
    • Recruiting
    • Universitaetsklinikum Halle - Saale
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitaetsklinikum Heidelberg
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
  • Wuerzburg, Germany, 97078
    • Recruiting
    • Universitaetsklinikum Wuerzburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • University of Hong Kong, Queen Mary Hospital
  • Shatin, New Territories, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
• Korea, Republic of
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Recruiting
    • Istituto Oncologico della Svizzera Italiana
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital Bern
  • Geneve 14, Switzerland, 1211
    • Recruiting
    • Hopitaux Universitaires de Geneve
• Taiwan
  • Tainan, Taiwan, 70403
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 33305
    • Recruiting
    • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute UK
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope National Medical Center
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California at SF
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Recruiting
      • Goshen Health Systems
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Community Health Network MD Anderson Cancer Center - North
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • American Oncology Partners, PA
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health Monter Cancer Center
    • New York, New York, United States, 10016
      • Recruiting
      • New York University Langone Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • Recruiting
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center Cancer Pavillion
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Mary Crowley Cancer Research
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Center for Oncology and Blood Disorders
    • Kingwood, Texas, United States, 77339
      • Recruiting
      • Lumi Research
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has provided informed consent/assent before initiation of any study specific activities/procedures.
• Age ≥ 18 years.
• Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b).
• Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
• Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product.
• Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Adequate hematopoietic function per local laboratory
• Adequate renal function per local laboratory
• Adequate glucose control per local laboratory (Part 1 only)
• Adequate liver function per local laboratory
• Adequate coagulation parameters
• Adequate pulmonary function
• Adequate cardiac function
• Minimum life expectancy of 12 weeks as per investigator judgement.
• A total of 25 slides of archived tumor tissue (formalin-fixed, paraffin-embedded [FFPE] sample collected within 5 years) or an archival block must be available.
• For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy.
• For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment.
• Part 1i: Enrollment criteria for Part 1i are to match the criteria of the expansion arm from which the indication was selected.
• For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only).

Food Effect Substudy (Part 1k): Specific Inclusion Criteria

• Subject able and willing to eat a standardized high-fat, high-caloric meal
• Subject able and willing to fast for ≥ 6 hours

Exclusion Criteria:

• Spinal cord compression or untreated brain metastases or leptomeningeal disease.
• History of other malignancy within the past 2 years
• Any evidence of current interstitial lung disease
• Active infection
• Evidence of active severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection.
• History of arterial thrombosis
• Myocardial infarction and/or symptomatic congestive heart failure.
• Gastrointestinal tract disease
• History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
• History of solid organ transplant.
• Diagnosis of Congenital Short QT Syndrome.
• Major surgery
• Anti-tumor therapy within 28 days of study day 1, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 28 days
• Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
• Prior treatment with docetaxel (Part 2 only)
• Prior irradiation to 25% of the bone marrow.
• Therapeutic or palliative radiation therapy within 2 weeks of study day 1.
• Live vaccine therapy within 4 weeks before study drug administration.
• Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
• Use of prescription medications that are known strong inducers of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1
• Unresolved toxicity from prior anti-cancer therapy
• Currently receiving treatment in another investigational device or drug study
• Known positive test for Human Immunodeficiency Virus (HIV).
• Positive hepatitis B surface antigen
• positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
• Female participants of childbearing potential unwilling to use protocol specified method of contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 2a, Phase 1: AMG 193 Dose Exploration + Docetaxel; Participants with MTAP-null NSCLC will receive escalating doses of AMG 193 + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; Drug: Docetaxel; Docetaxel: Intravenous infusion
Experimental: Part 2b, Phase 1: AMG 193 + Docetaxel Dose Expansion; Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of AMG 193 + docetaxel.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; Drug: Docetaxel; Docetaxel: Intravenous infusion
Experimental: Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration; Participants with MTAP-null solid tumors will receive escalating doses of AMG 193 to estimate the MTD and/or the RP2D. A group of these participants in the United States (US) will have the option to take part in a Drug Substance Particle Size (DSPS) assessment. These participants will receive escalating doses of AMG 193 and a dose of a comparator AMG 193 test tablet.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; Drug: Comparator AMG 193 Test Tablet; Comparator AMG 193 test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator AMG 193 test tablet.
Experimental: Part 1c, Phase 1: AMG 193 Monotherapy Dose Expansion; Participants will receive the identified MTD/RP2D of AMG 193 in the following cohort: MTAP-null or lost MTAP expression NSCLC.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 3: AMG 193 Phase 2; Participants with MTAP-null solid tumors will receive AMG 193.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 1e, Phase 1: AMG 193 Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null BTC.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 1f, Phase 1: AMG 193 Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null head and neck squamous cell carcinoma (HNSCC)	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 1g, Phase 1: AMG 193 Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null pancreatic adenocarcinoma	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 1h, Phase 1: AMG 193 Monotherapy Dose Expansion; Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor).	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 1i, Phase 1: AMG 193 Dose Optimization; Participants will receive a randomized dose optimization evaluation of AMG 193.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor
Experimental: Part 1j, Phase 1: AMG 193 DSPS Substudy (US Sites Only); Participants will receive doses of AMG 193 and comparator AMG 193 test tables at different times in a fasted state.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor; Drug: Comparator AMG 193 Test Tablet; Comparator AMG 193 test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator AMG 193 test tablet.
Experimental: Part 1k, Phase 1: AMG 193 Food Effect Substudy (US Sites Only); Participants will receive AMG 193 once on a fasted state and once after eating a standardized high-fat, high calorie meal.	Drug: AMG 193; AMG 193: Orally via tablet; Other Names: MTA Cooperative PRMT5 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)		28 days
Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)	Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs. Serious AEs (SAEs) are defined as any event that meets at least 1 of the following serious criteria: Results in death (fatal); Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other medically important serious event	Up to approximately 2 years
Part 3: Objective Response Rate (ORR)		Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Parts 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Parts 1 and 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of AMG 193		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days)
Part 2 Only: Maximal Plasma Concentration (Cmax) of Docetaxel		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Part 2 Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Docetaxel		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Part 2 Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Docetaxel		Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days)
Parts 1, 2 and 3: Disease Control Rate (DCR)		Up to approximately 2 years
Parts 1, 2 and 3: Duration of Response (DoR)		Up to approximately 2 years
Parts 1, 2 and 3: Time to Response (TTR)		Up to approximately 2 years
Parts 1, 2 and 3: Duration of Stable Disease (SD)		Up to approximately 2 years
Parts 1, 2 and 3: Progression-Free Survival (PFS)		Up to approximately 2 years
Parts 1, 2 and 3: Overall Survival (OS)		Up to approximately 2 years
Parts 1 and 2: ORR		Up to approximately 2 years
Part 3 Only: Number of Participants Who Experience TEAE	AEs are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, ECGs and clinical laboratory tests will be recorded as TEAEs. SAEs are defined as any event that meets at least 1 of the following serious criteria: Results in death (fatal); Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other medically important serious event	Up to approximately 2 years
Part 1a Only: Maximal Plasma Concentration (Cmax) of AMG 193		Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193		Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of AMG 193		Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days)
Part 1a Only: Maximal Plasma Concentration (Cmax) of Comparator AMG 193 Test Tablet		Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Comparator AMG 193 Test Tablet		Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Comparator AMG 193 Test Tablet		Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days)
Part 1k Only: Cmax of AMG 193 during fasted state		Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Tmax of AMG 193 during fasted state		Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: AUC of AMG 193 during fasted state		Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Cmax of AMG 193 during fed state		Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: Tmax of AMG 193 during fed state		Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)
Part 1k Only: AUC of AMG 193 during fed state		Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): March 12, 2029

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; Pancreatic adenocarcinoma; Metastatic MTAP-null solid tumors; Advanced MTAP-null solid tumors; Head and neck squamous cell carcinoma; Biliary Tract Cancer (BTC)
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 20210023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No