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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04185883

Studienbeginn:
Dezember 2019

Letztes Update:
25.04.2024

Wirkstoff:
Sotorasib, AMG 404, Trametinib, RMC-4630, Afatinib, Pembrolizumab, Panitumumab, Atezolizumab, Everolimus, Palbociclib, MVASI® (bevacizumab-awwb), TNO155, carboplatin, pemetrexed, docetaxel, paclitaxel, BI 1701963, Intravenous (IV) Chemotherapy (Regimen 1), IV Chemotherapy (Regimen 2)

Indikation (Clinical Trials):
Neoplasms, Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 90)

Charite Universitaetsmedizin Berlin, Campus Virchow
13353 Berlin
(Berlin)
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Universitaetsklinikum Dresden
01307 Dresden
(Sachsen)
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Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
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Universitatsklinikum Koln
50937 Koeln
(Nordrhein-Westfalen)
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Arizona Oncology Associates Professional Corporation
85711 Tucson
United StatesRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
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University of California San Diego Moores Cancer Center
92093 La Jolla
United StatesAbgeschlossen» Google-Maps
Loma Linda University Cancer Center
92354 Loma Linda
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University of Southern California, Norris Comprehensive Cancer Center
90033 Los Angeles
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University of California Davis Medical Center
95817 Sacramento
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University of California at SF
94115 San Francisco
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University of California Los Angeles
90404 Santa Monica
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Rocky Mountain Cancer Centers Denver Midtown
80218 Denver
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Sarah Cannon Research Institute at HealthONE
80218 Denver
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Memorial Cancer Institute
33028 Pembroke Pines
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Northwestern University
60637 Chicago
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University of Chicago Medical Center
60637 Chicago
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Indiana University
46202 Indianapolis
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University of Iowa Hospitals and Clinics
52242 Iowa City
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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
21224 Baltimore
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University of Michigan
48109-5912 Ann Arbor
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Henry Ford Health System
48202 Detroit
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Washington University
63110-1093 Saint Louis
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Montefiore Medical Center
10461 Bronx
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Roswell Park Cancer Institute
32224 Buffalo
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Icahn School of Medicine at Mount Sinai
10029 New York
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Columbia University Medical Center
10032 New York
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Memorial Sloan Kettering Cancer Center
10065 New York
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Levine Cancer Institute
28204 Charlotte
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Duke University Medical Center
27710 Durham
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University of Cincinnati Medical Center
45267 Cincinnati
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Providence Portland Medical Center
97213 Portland
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Oregon Health and Science University
97239 Portland
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Thomas Jefferson University
19107 Philadelphia
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Fox Chase Cancer Center
19111 Philadelphia
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University of Pennsylvania
19111 Philadelphia
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University of Pittsburgh Medical Center Cancer Pavillion
15232 Pittsburgh
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Gibbs Cancer Center and Research Institute - Spartanburg
29303 Spartanburg
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Avera Cancer Institute
57108 Sioux Falls
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Henry Joyce Cancer Center
37232 Nashville
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Texas Oncology - Austin Midtown
78705 Austin
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Mary Crowley Cancer Research
75230 Dallas
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University of Texas Southwestern Medical Center
75390 Dallas
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University of Texas MD Anderson Cancer Center
77030 Houston
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United States Oncology Regulatory Affairs Corporate Office
77380 The Woodlands
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US Oncology Research Investigational Products Center
77380 The Woodlands
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Texas Oncology Northeast Texas
75702 Tyler
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Huntsman Cancer Institute
84112 Salt Lake City
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University of Virginia
22903 Charlottesville
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Virginia Cancer Specialists, PC
22031 Fairfax
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Fred Hutchinson Cancer Center
98109 Seattle
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Northwest Medical Specialties, PLLC
98405 Tacoma
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Northwest Cancer Specialists - Vancouver
98684 Vancouver
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GenesisCare -North Shore Oncology
2065 St Leonards
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Icon Cancer Care South Brisbane
4101 South Brisbane
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The Queen Elizabeth Hospital
5011 Woodville South
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Universite Catholique de Louvain Cliniques Universitaires Saint Luc
1200 Bruxelles
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Universitair Ziekenhuis Antwerpen
2650 Edegem
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CHU de Quebec Hopital de l Enfant Jesus
G1J 1Z4 Quebec
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Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
20162 Milano
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Azienda Ospedaliero Universitaria Pisana Ospedale Santa Chiara
56126 Pisa
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Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
37126 Verona
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National Cancer Center Hospital East
277-8577 Kashiwa-shi
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The Cancer Institute Hospital of Japanese Foundation for Cancer Research
135-8550 Koto-ku
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Seoul National University Hospital
03080 Seoul
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The Catholic University of Korea Seoul St Marys Hospital
06591 Seoul
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Asan Medical Center
138-736 Seoul
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Universitair Medisch Centrum Utrecht
3584 CX Utrecht
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Hospital Universitari Vall d Hebron
08035 Barcelona
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Hospital Clinic i Provincial de Barcelona
08036 Barcelona
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Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
08908 Hospitalet de Llobregat
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Hospital Universitario Puerta de Hierro Majadahonda
28222 Majadahonda
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Hospital Universitario Ramon y Cajal
28034 Madrid
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Hospital Universitario 12 de Octubre
28041 Madrid
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National Cheng Kung University Hospital
70403 Tainan
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National Taiwan University Hospital
10002 Taipei
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Taipei Veterans General Hospital
11217 Taipei
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Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
33305 Taoyuan
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Sarah Cannon Research Institute UK
W1G 6AD London
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) (Time Frame - 12 Months)

2. Phase 1b: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Time Frame - 12 Months)

3. Phase 1b: Number of Participants with Treatment-related Adverse Events (Time Frame - 12 Months)

4. Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs (Time Frame - 12 Months)

5. Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements (Time Frame - 12 Months)

6. Phase 2: Objective Response Rate (Time Frame - 12 Months)

7. Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values (Time Frame - 12 Months)

Secondary outcome:

1. Phase 1b: Maximum Plasma Concentration (Cmax) (Time Frame - 12 Months)

2. Phase 1b: Time to Maximum Plasma Concentration (Tmax) (Time Frame - 12 Months)

3. Phase 1b: Area Under the Plasma Concentration-time Curve (AUC) (Time Frame - 12 Months)

4. Phase 1b: Objective Response Rate (Time Frame - 12 Months)

5. Phase 1b: Disease Control Rate (Time Frame - 12 Months)

6. Phase 1b: Duration of Response (Time Frame - 12 Months)

7. Phase 1b: Progression-free Survival (Time Frame - 12 Months)

8. Phase 1b: Duration of Stable Disease (Time Frame - 12 Months)

9. Phase 1b: Time to Response (Time Frame - 12 Months)

10. Phase 1b: Overall Survival (Time Frame - 12 Months)

11. Phase 1b: Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels (Time Frame - 12 Months)

12. 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).

13. 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).

14. 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).

15. Phase 1b: Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy (Time Frame - 12 Months)

16. 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)

17. Phase 1b: Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS) (Time Frame - 12 Months):
Non-intracranial PFS assessed per RECIST 1.1.

18. Phase 1b: Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS) (Time Frame - 12 Months):
Overall PFS assessed per RECIST 1.1 and RANO-BM.

19. Phase 1b: Sotorasib + TNO155 Only: Best Overall Response (Time Frame - 12 Months)

20. Phase 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Time Frame - 12 Months)

21. Phase 2: Number of Participants with Grade ≥3 Treatment-emergent Adverse Events (TEAEs) (Time Frame - 12 Months)

22. Phase 2: Maximum Plasma Concentration (Cmax) (Time Frame - 12 Months)

23. Phase 2: Time to Maximum Plasma Concentration (Tmax) (Time Frame - 12 Months)

24. Phase 2: Area Under the Plasma Concentration-time Curve (AUC) (Time Frame - 12 Months)

25. Phase 2: Disease Control Rate (Time Frame - 12 Months)

26. Phase 2: Duration of Response (Time Frame - 12 Months)

27. Phase 2: Progression-free Survival (Time Frame - 12 Months)

28. Phase 2: Time to Response (Time Frame - 12 Months)

29. Phase 2: Overall Survival (Time Frame - 12 Months)

30. Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs) (Time Frame - 12 Months)

31. Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Time Frame - 12 Months)

32. Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events (Time Frame - 12 Months)

33. Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs (Time Frame - 12 Months)

34. Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements (Time Frame - 12 Months)

35. Phase 1b: Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values (Time Frame - 12 Months)

Studien-Arme

  • 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 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.
  • 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.
  • 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 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.
  • Experimental: Sotorasib + panitumumab +/- chemotherapy
    Experimental: Sotorasib + panitumumab +/- chemotherapy 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.
  • Experimental: Sotorasib + atezolizumab
    Experimental: 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.
  • Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
    Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, 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.
  • 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.
  • 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.
  • 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 mutant 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 non small cell lung cancer.
  • Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy
    Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy 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.
  • Experimental: Sotorasib + TNO155
    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.
  • Experimental: Sotorasib + BI 1701963
    Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.
  • 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
  • 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.

Geprüfte Regime

  • Sotorasib:
    Sotorasib administered orally as a tablet.
  • Trametinib:
    Trametinib administered orally as a tablet.
  • RMC-4630:
    RMC-4630 administered orally as a capsule.
  • Afatinib:
    afatinib administered orally as a tablet.
  • Pembrolizumab:
    pembrolizumab administered as an intravenous (IV) infusion.
  • Panitumumab:
    Panitumumab administered as an intravenous (IV) infusion.
  • Carboplatin, pemetrexed, docetaxel, paclitaxel:
    Carboplatin, pemetrexed, docetaxel administered as an intravenous (IV) infusion.
  • Atezolizumab:
    Atezolizumab administered as an intravenous (IV) injection.
  • Palbociclib:
    Palbociclib administered orally as a tablet.
  • MVASI® (bevacizumab-awwb):
    MVASI® (bevacizumab-awwb) administered as an intravenous (IV) infusion.
  • TNO155:
    TNO155 administered orally as a capsule.
  • Intravenous (IV) Chemotherapy (Regimen 1):
    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):
    IV 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 oxaliplatin administered as IV injection.
  • BI 1701963:
    BI 1701963 administered orally
  • AMG 404:
    AMG 404 administered as an intravenous (IV) infusion.
  • Everolimus:
    Everolimus administered orally.

Quelle: ClinicalTrials.gov


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