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The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daraxonrasib | Experimental | study drug |
|
| SOC Observation | No Intervention | Patients randomized to the comparator control arm will receive SOC observation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daraxonrasib | Drug | oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) per Investigator | DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time from randomization until death from any cause. | Up to approximately 5 years |
| DFS per blinded independent central review (BICR) | DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Revolution Medicines Study Director | Contact | 1-844-2-REVMED | medinfo@revmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Cancer at Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| Up to approximately 5 years |
| DFS Rate at 1 year and 2 years | DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively. | Up to approximately 2 years |
| OS rate at 1 year and 2 years | OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively. | Up to approximately 2 years |
| Safety and tolerability of daraxonrasib | Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests. | Up to approximately 5 years |
| Pharmacokinetics (PK) | Predose concentration of daraxonrasib | Up to Cycle 4 Day 1 (Day 85) |
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90404 | United States |
|
| Stanford Cancer Institute | Recruiting | Palo Alto | California | 94304 | United States |
|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| Rocky Mountain Cancer Centers, LLP | Recruiting | Lakewood | Colorado | 80228 | United States |
| Hartford Healthcare | Recruiting | Hartford | Connecticut | 06103 | United States |
|
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
|
| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Community Health Network | Recruiting | Indianapolis | Indiana | 46250 | United States |
|
| University of Kansas Medical Center Research Institute, Inc. | Recruiting | Lawrence | Kansas | 66045 | United States |
| Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute (DFCI) | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Mayo Clinic Cancer Center | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Saint Luke's Cancer Institute | Recruiting | Kansas City | Missouri | 64111 | United States |
|
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| Comprehensive Cancer Centers of Nevada | Recruiting | Las Vegas | Nevada | 89169 | United States |
|
| Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center | Recruiting | New York | New York | 10016 | United States |
|
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | United States |
| Taylor Cancer Research Center | Recruiting | Maumee | Ohio | 43537 | United States |
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| Avera Cancer Institute | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - DFW | Recruiting | Dallas | Texas | 75246 | United States |
| Texas Oncology - Northeast Texas | Recruiting | Longview | Texas | 75601 | United States |
|
| University of Utah, Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 94112 | United States |
|
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
| CRLCC Eugene Marquis | Recruiting | Rennes | Cedex | 35042 | France |
| Hôpital Paul Brousse | Recruiting | Villejuif | Val-De- Marne | 94804 | France |
| IEO - Instituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| Kanagawa Cancer Center | Recruiting | Yokohama | Kanagawa | 241-8515 | Japan |
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| Cancer Institute Hospital of JFCR | Recruiting | Tokyo | 135-8550 | Japan |
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| Pan American Oncology Trials, LLC | Recruiting | San Juan | 00909 | Puerto Rico |
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| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre | Recruiting | Birmingham | B15 2TH | United Kingdom |
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| Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | G22 0YN | United Kingdom |
| The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London | Recruiting | London | SW3 6JJ | United Kingdom |
|
| Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
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| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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