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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506794-35 | Other Identifier | CTIS |
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To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotorasib + trametinib + panitumumab | Experimental | Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion
|
|
| Sotorasib + RMC-4630 | Experimental | Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion
|
|
| Sotorasib + afatinib | Experimental | Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion
|
|
| Sotorasib + panitumumab +/- chemotherapy | Experimental | Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotorasib | Drug | Sotorasib administered orally as a tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicities (DLTs) | 12 Months | |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | 12 Months | |
| Number of Participants with Treatment-related Adverse Events | 12 Months | |
| Number of Participants with Clinically Significant Changes in Vital Signs | 12 Months | |
| Number of Participants with Clinically Significant Changes in ECG Measurements | 12 Months | |
| Number of Participants with Clinically Significant Changes in Laboratory Test Values | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 12 Months | |
| Time to Maximum Plasma Concentration (Tmax) | 12 Months | |
| Area Under the Plasma Concentration-time Curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates Professional Corporation | Tucson | Arizona | 85711 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38177853 | Background | Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
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.
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|
| Sotorasib + atezolizumab | Experimental | Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion
|
|
| Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab | Experimental | Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion
|
|
| Sotorasib Monotherapy | Experimental | Experimental: Sotorasib only Dose Exploration and Dose Expansion
|
|
| Sotorasib + palbociclib | Experimental | Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion
|
|
| Sotorasib + pembrolizumab | Experimental | Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion
|
|
| Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy | Experimental | Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion
|
|
| Sotorasib + TNO155 | Experimental | Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion
|
|
| Sotorasib + BI 1701963 | Experimental | Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion
|
|
| Sotorasib + AMG 404 | Experimental | 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 |
|
| Sotorasib + everolimus | Experimental | 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. |
|
| Trametinib | Drug | Trametinib administered orally as a tablet. |
|
| RMC-4630 | Drug | RMC-4630 administered orally as a capsule. |
|
| Afatinib | Drug | afatinib administered orally as a tablet. |
|
| Pembrolizumab | Drug | pembrolizumab administered as an intravenous (IV) infusion. |
|
| Panitumumab | Drug | Panitumumab administered as an IV infusion. |
|
| Carboplatin, pemetrexed, docetaxel, paclitaxel | Drug | Carboplatin, pemetrexed, docetaxel administered as an IV infusion. |
|
| Atezolizumab | Drug | Atezolizumab administered as an IV injection. |
|
| Palbociclib | Drug | Palbociclib administered orally as a tablet. |
|
| MVASI® (bevacizumab-awwb) | Drug | MVASI® (bevacizumab-awwb) administered as an IV infusion. |
|
| TNO155 | Drug | TNO155 administered orally as a capsule. |
|
| IV Chemotherapy (Regimen 1) | Drug | Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection. |
|
| IV Chemotherapy (Regimen 2) | Drug | IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection. |
|
| BI 1701963 | Drug | BI 1701963 administered orally |
|
| AMG 404 | Drug | AMG 404 administered as an IV infusion. |
|
| Everolimus | Drug | Everolimus administered orally. |
|
| 12 Months |
| Objective Response Rate | 12 Months |
| Disease Control Rate | 12 Months |
| Duration of Response | 12 Months |
| Progression-free Survival | 12 Months |
| Duration of Stable Disease | 12 Months |
| Time to Response | 12 Months |
| Overall Survival | 12 Months |
| Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels | 12 Months |
| Sotorasib Monotherapy Only: Intracranial Objective Response Rate | Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM). | 12 Months |
| Sotorasib Monotherapy Only: Intracranial Disease Control Rate | Intracranial disease control rate assessed per RANO-BM. | 12 Months |
| Sotorasib Monotherapy Only: Intracranial Duration of Response | Intracranial duration of response assessed per RANO-BM. | 12 Months |
| Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy | 12 Months |
| Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS) | Intracranial PFS assessed per RANO-BM. | 12 Months |
| Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS) | Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. | 12 Months |
| Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS) | Overall PFS assessed per RECIST 1.1 and RANO-BM. | 12 Months |
| Sotorasib + TNO155 Only: Best Overall Response | 12 Months |
| Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs) | 12 Months |
| Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs) | 12 Months |
| Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events | 12 Months |
| Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs | 12 Months |
| Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements | 12 Months |
| Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values | 12 Months |
| Duarte |
| California |
| 91010 |
| United States |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Loma Linda University Cancer Center | Loma Linda | California | 92354 | United States |
| University of Southern California, Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| University of California San Francisco Mission Bay Campus | San Francisco | California | 94115 | United States |
| University of California Los Angeles | Santa Monica | California | 90404 | United States |
| Rocky Mountain Cancer Centers Denver Midtown | Denver | Colorado | 80218 | United States |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5912 | United States |
| Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion) | Detroit | Michigan | 48202 | United States |
| Washington University | St Louis | Missouri | 63110-1093 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 32224 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Gibbs Cancer Center and Research Institute - Spartanburg | Spartanburg | South Carolina | 29303 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57108 | United States |
| United States Oncology Regulatory Affairs Corporate Office | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Oncology Central-South | Austin | Texas | 78705 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Oncology Consultants | Houston | Texas | 77030 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| US Oncology Research Investigational Products Center | The Woodlands | Texas | 77380 | United States |
| Texas Oncology Northeast Texas | Tyler | Texas | 75702 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | United States |
| Nepean Cancer Centre | Kingswood | New South Wales | 2747 | Australia |
| GenesisCare -North Shore Oncology | St Leonards | New South Wales | 2065 | Australia |
| Icon Cancer Care South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| St John of God Healthcare | Subiaco | Western Australia | 6008 | Australia |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| CHU de Quebec Hopital de l Enfant Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Charite Universitaetsmedizin Berlin, Campus Virchow | Berlin | 13353 | Germany |
| Universitatsklinikum Koln | Cologne | 50937 | Germany |
| Universitaetsklinikum Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Centro Ricerche Cliniche Di Verona Societa responsabilita limitata | Verona | 37126 | Italy |
| Aichi Cancer Center | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Chiba | 277-8577 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals | L'Hospitalet de Llobregat | Catalonia | 08908 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation | Taoyuan | 33305 | Taiwan |
| Sarah Cannon Research Institute UK | London | W1G 6AD | United Kingdom |
| ID | Term |
|---|---|
| C000706028 | sotorasib |
| C560077 | trametinib |
| D000077716 | Afatinib |
| C582435 | pembrolizumab |
| D000077544 | Panitumumab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| C000594389 | atezolizumab |
| C500026 | palbociclib |
| D000068258 | Bevacizumab |
| D004358 | Drug Therapy |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
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