Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04185883

Recruitment Status : Recruiting

First Posted : December 4, 2019

Last Update Posted : August 4, 2022

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Amgen

Study Description

Brief Summary:

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation	Drug: Sotorasib Drug: AMG 404 Drug: trametinib Drug: RMC-4630 Drug: afatinib Drug: pembrolizumab Drug: panitumumab Drug: carboplatin, pemetrexed, docetaxel Drug: atezolizumab Drug: everolimus Drug: palbociclib Drug: MVASI® (bevacizumab-awwb) Drug: TNO155 Drug: FOLFIRI Drug: FOLFOX Drug: Loperamide	Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1054 participants
Allocation:	Non-Randomized
Intervention Model:	Sequential Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Actual Study Start Date :	December 17, 2019
Estimated Primary Completion Date :	August 26, 2024
Estimated Study Completion Date :	November 11, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Sotorasib

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sotorasib + trametinib Experimental: Sotorasib + trametinib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: trametinib trametinib administered orally as a tablet.
Experimental: Sotorasib + AMG 404 Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: AMG 404 AMG 404 administered as an intravenous (IV) infusion.
Experimental: Sotorasib + RMC-4630 Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: RMC-4630 RMC-4630 administered orally as a capsule.
Experimental: Sotorasib + afatinib Experimental:Sotorasib + afatinib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: afatinib afatinib administered orally as a tablet.
Experimental: Sotorasib + pembrolizumab Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: pembrolizumab pembrolizumab administered as an intravenous (IV) infusion.
Experimental: Sotorasib + panitumumab +/- FOLFIRI Experimental: Sotorasib + panitumumab +/- FOLFIRI Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: panitumumab panitumumab administered as an intravenous (IV) infusion. Drug: FOLFIRI FOLFIRI chemotherapy combination of leucovorin administered as an intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
Experimental: Sotorasib + atezolizumab Sotorasib + atezolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: atezolizumab atezolizumab administered as an intravenous (IV) injection.
Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, pembrolizumab Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, pembrolizumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: pembrolizumab pembrolizumab administered as an intravenous (IV) infusion. Drug: carboplatin, pemetrexed, docetaxel carboplatin, pemetrexed, docetaxel administered as an intravenous (IV) infusion.
Experimental: Sotorasib Monotherapy Experimental: Sotorasib only Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.	Drug: Sotorasib Sotorasib administered orally as a tablet.
Experimental: Sotorasib + palbociclib Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: palbociclib palbociclib administered orally as a tablet.
Experimental: Sotorasib + everolimus Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: everolimus everolimus administered orally.
Experimental: Sotorasib + trametinib+ panitumumab Experimental: Sotorasib + trametinib+ panitumumab Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant advanced colorectal cancer.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: trametinib trametinib administered orally as a tablet. Drug: panitumumab panitumumab administered as an intravenous (IV) infusion.
Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ FOLFIRI or FOLFOX Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: MVASI® (bevacizumab-awwb) MVASI® (bevacizumab-awwb) administered as an intravenous (IV) infusion. Drug: FOLFIRI FOLFIRI chemotherapy combination of leucovorin administered as an intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection. Drug: FOLFOX FOLFOX chemotherapy combination of leucovorin administered as intravenous (IV) injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.
Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: TNO155 TNO155 administered orally as a capsule.
Experimental: Sotorasib + afatinib + loperamide Dose Expansion • Upon completing the dose exploration part of the study with sotorasib + afatinib, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer, who will receive sotorasib + afatinib + loperamide.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: afatinib afatinib administered orally as a tablet. Drug: Loperamide Loperamide administered orally as a capsule.

Outcome Measures

Primary Outcome Measures :

Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 12 Months ]
Phase 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
Phase 1b: Number of Participants with Treatment-related Adverse Events [ Time Frame: 12 Months ]
Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: 12 Months ]
Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements [ Time Frame: 12 Months ]
Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values [ Time Frame: 12 Months ]
Phase 2: Objective Response Rate [ Time Frame: 12 Months ]

Secondary Outcome Measures :

Phase 1b: Maximum Plasma Concentration (Cmax) [ Time Frame: 12 Months ]
Phase 1b: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 Months ]
Phase 1b: Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 Months ]
Phase 1b: Objective Response Rate [ Time Frame: 12 Months ]
Phase 1b: Disease Control Rate [ Time Frame: 12 Months ]
Phase 1b: Duration of Response [ Time Frame: 12 Months ]
Phase 1b: Progression-free Survival [ Time Frame: 12 Months ]
Phase 1b: Duration of Stable Disease [ Time Frame: 12 Months ]
Phase 1b: Time to Response [ Time Frame: 12 Months ]
Phase 1b: Overall Survival [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels [ Time Frame: 12 Months ]
Phase 1b: Sotorasib Monotherapy Only: Intracranial Objective Response Rate [ Time Frame: 12 Months ]
Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Phase 1b: Sotorasib Monotherapy Only: Intracranial Disease Control Rate [ Time Frame: 12 Months ]
Intracranial disease control rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Phase 1b: Sotorasib Monotherapy Only: Intracranial Duration of Response [ Time Frame: 12 Months ]
Intracranial duration of response assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).
Phase 1b: Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy [ Time Frame: 12 Months ]
Phase 1b: Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS) [ Time Frame: 12 Months ]
Intracranial PFS assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM)
Phase 1b: Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS) [ Time Frame: 12 Months ]
Non-intracranial PFS assessed per RECIST 1.1.
Phase 1b: Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS) [ Time Frame: 12 Months ]
Overall PFS assessed per RECIST 1.1 and RANO-BM.
Phase 1b: Sotorasib + TNO155 Only: Best Overall Response [ Time Frame: 12 Months ]
Phase 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
Phase 2: Number of Participants with Grade ≥3 Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
Phase 2: Maximum Plasma Concentration (Cmax) [ Time Frame: 12 Months ]
Phase 2: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 Months ]
Phase 2: Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 Months ]
Phase 2: Disease Control Rate [ Time Frame: 12 Months ]
Phase 2: Duration of Response [ Time Frame: 12 Months ]
Phase 2: Progression-free Survival [ Time Frame: 12 Months ]
Phase 2: Time to Response [ Time Frame: 12 Months ]
Phase 2: Overall Survival [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements [ Time Frame: 12 Months ]
Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values [ Time Frame: 12 Months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women greater than or equal to 18 years old.
Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria:

Primary brain tumor.
Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
Myocardial infarction within 6 months of study day 1.
Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185883

Contacts

Layout table for location contacts

Contact: Amgen Call Center	866-572-6436	medinfo@amgen.com

Locations

Show 73 study locations

Layout table for location information

United States, Arizona
Arizona Oncology Associates Professional Corporation	Recruiting
Tucson, Arizona, United States, 85711
United States, California
City of Hope National Medical Center	Recruiting
Duarte, California, United States, 91010
University of California San Diego Moores Cancer Center	Recruiting
La Jolla, California, United States, 92093
Loma Linda University Cancer Center	Recruiting
Loma Linda, California, United States, 92354
University of Southern California, Norris Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90033
University of California Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
University of California at SF	Recruiting
San Francisco, California, United States, 94115
University of California Los Angeles	Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Rocky Mountain Cancer Centers Denver Midtown	Recruiting
Denver, Colorado, United States, 80218
Sarah Cannon Research Institute at HealthONE	Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Yale Cancer Center	Recruiting
New Haven, Connecticut, United States, 06520
Norwalk Hospital	Recruiting
Norwalk, Connecticut, United States, 06856
United States, Florida
Memorial Cancer Institute	Recruiting
Pembroke Pines, Florida, United States, 33028
Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30332
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60637
University of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Recruiting
Baltimore, Maryland, United States, 21224
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109-5912
Henry Ford Health System	Recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University	Recruiting
Saint Louis, Missouri, United States, 63110-1093
United States, New York
Montefiore Medical Center	Terminated
Bronx, New York, United States, 10461
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263
Icahn School of Medicine at Mount Sinai	Recruiting
New York, New York, United States, 10029
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute	Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center	Recruiting
Cincinnati, Ohio, United States, 45267
Cleveland Clinic	Terminated
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Portland Medical Center	Recruiting
Portland, Oregon, United States, 97213
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center Cancer Pavillion	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Gibbs Cancer Center and Research Institute - Spartanburg	Recruiting
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute	Terminated
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Henry Joyce Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology - Austin Midtown	Recruiting
Austin, Texas, United States, 78705
Mary Crowley Cancer Research	Recruiting
Dallas, Texas, United States, 75230
University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Texas Oncology-Tyler	Recruiting
Tyler, Texas, United States, 75702
United States, Utah
Huntsman Cancer Institute	Recruiting
Salt Lake City, Utah, United States, 84112
United States, Virginia
United States Oncology Regulatory Affairs Corporate Office	Recruiting
Fairfax, Virginia, United States, 22031
US Oncology Research Investigational Products Center	Recruiting
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC	Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Northwest Cancer Specialists - Vancouver	Recruiting
Vancouver, Washington, United States, 98684
Australia, New South Wales
GenesisCare -North Shore (Oncology)	Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Icon Cancer Care South Brisbane	Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
The Queen Elizabeth Hospital	Recruiting
Woodville South, South Australia, Australia, 5011
Australia, Western Australia
St John of God Healthcare	Recruiting
Subiaco, Western Australia, Australia, 6008
Austria
Medizinische Universitaet Graz	Recruiting
Graz, Austria, 8036
Universitaetsklinikum Salzburg	Recruiting
Salzburg, Austria, 5020
Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc	Recruiting
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Antwerpen	Recruiting
Edegem, Belgium, 2650
Canada
CHU de Quebec Hopital de l Enfant Jesus	Recruiting
Quebec, Canada, G1J 1Z4
Germany
Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum	Recruiting
Berlin, Germany, 13353
Universitaetsklinikum Carl Gustav Carus	Recruiting
Dresden, Germany, 01307
Japan
Aichi Cancer Center	Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Center Hospital East	Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 03080
The Catholic University of Korea Seoul St Marys Hospital	Recruiting
Seoul, Korea, Republic of, 06591
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Spain
Hospital Universitari Vall d Hebron	Recruiting
Barcelona, Cataluña, Spain, 08035
Hospital Clinic i Provincial de Barcelona	Recruiting
Barcelona, Cataluña, Spain, 08036
Instituto Catalan de Oncologia Hospital Duran i Reynals	Recruiting
Hospitalet de Llobregat, Cataluña, Spain, 08908
Hospital Universitario Ramon y Cajal	Recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre	Recruiting
Madrid, Spain, 28041

Sponsors and Collaborators

Amgen

Investigators

Layout table for investigator information

Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Layout table for additonal information

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT04185883
Other Study ID Numbers:	20190135
First Posted:	December 4, 2019 Key Record Dates
Last Update Posted:	August 4, 2022
Last Verified:	August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
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 (or other new use) 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.
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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
URL:	http://www.amgen.com/datasharing

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Neoplasms Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Bevacizumab Pembrolizumab Panitumumab Carboplatin Docetaxel Pemetrexed Everolimus Atezolizumab Palbociclib Trametinib Afatinib	Loperamide Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

To Top