Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma (RASolute 309)
A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients With Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.
調査の概要
状態
詳細な説明
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib plus zoldonrasib will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic KRAS G12D-mutated pancreatic adenocarcinoma.
Patients will be randomized to one of two arms: daraxonrasib + zoldonrasib (Arm A) or gemcitabine and nab-paclitaxel (Arm B).
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Revolution Medicines Study Director
- 電話番号：1-844-2-REVMED
- メール：medinfo@revmed.com
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85054
- 募集
- Mayo Clinic Arizona
-
コンタクト：
- Tanios S. Bekaii-Saab
- 電話番号：855-776-0015
-
Scottsdale、Arizona、アメリカ、85258
- 募集
- HonorHealth Research Institute
-
コンタクト：
- Amy Malensek
- 電話番号：480-323-1350
- メール：amalensek@honorhealth.com
-
-
Florida
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Jacksonville、Florida、アメリカ、32224
- 募集
- Mayo Clinic Florida
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コンタクト：
- Hani M. Babiker
- 電話番号：855-776-0015
-
Tampa、Florida、アメリカ、33612
- 募集
- Moffitt Cancer Center
-
コンタクト：
- Cheyenne Schneider
- 電話番号：813-745-5166
- メール：Cheyenne.Schneider@moffitt.org
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic Rochester
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コンタクト：
- Ben George
- 電話番号：855-776-0015
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-
Rhode Island
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Providence、Rhode Island、アメリカ、02903
- 募集
- Rhode Island Hospital
-
コンタクト：
- Andrew Schumacher
- 電話番号：401-444-3234
- メール：aschumacher@brownhealth.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting.
- No prior treatment in the locally advanced unresectable or metastatic setting
- Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
- Documented KRAS G12D mutation status.
- Measurable disease per RECIST v1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
Exclusion Criteria:
- Mutation status with known driver mutations for which there are approved targeted therapies.
- Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies.
- Tumors determined to originate from non-pancreatic primary sites.
- Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting.
- Active or known history of untreated central nervous system metastatic or leptomeningeal disease.
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery within 28 days prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
- Additional inclusion & exclusion criteria may apply.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm A: daraxonrasib + zoldonrasib
combination of study drugs |
oral tablets oral tablets |
|
実験的：Arm B: gemcitabine and nab-paclitaxel
chemotherapy |
IV infusion intravenous (IV) infusion |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival (OS)
時間枠：Up to approximately 4 years
|
OS is defined as the time from randomization until death from any cause. |
Up to approximately 4 years
|
|
Progression free survival (PFS)
時間枠：Up to approximately 4 years
|
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator. |
Up to approximately 4 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events (AEs)
時間枠：Up to approximately 4 years
|
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 |
Up to approximately 4 years
|
|
Changes in clinical laboratory test values
時間枠：Up to approximately 4 years
|
Number of patients with changes from baseline in clinical laboratory test values |
Up to approximately 4 years
|
|
Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) pain scale
時間枠：Up to approximately 4 years
|
EORTC QLQ-PAN26 consists of 26 questions relating to disease symptoms, treatment side effects and emotional issues specific to pancreatic cancer. The pancreatic pain subscale assesses abdominal pain, back pain, and pain while lying down. Change in score from baseline in the pain subscale will be assessed with higher scores on the pain subscale indicating more severe pain and worsening function. |
Up to approximately 4 years
|
|
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status score
時間枠：Up to approximately 4 years
|
EORTC QLQ-C30 consists of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. It uses a mix of 4-point scales and 7-point scales. Change from baseline in EORTC QLQ-C30 global health status will be assessed. Higher scores on functional scales reflect better functioning, whereas higher scores on symptom scales reflect higher symptom burden. |
Up to approximately 4 years
|
|
PFS by blinded independent central review (BICR)
時間枠：Up to approximately 4 years
|
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR |
Up to approximately 4 years
|
|
Objective response rate (ORR)
時間枠：Up to approximately 4 years
|
Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator. |
Up to approximately 4 years
|
|
Duration of response (DOR)
時間枠：Up to approximately 4 years
|
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator. |
Up to approximately 4 years
|
|
Changes in vital signs
時間枠：Up to approximately 4 years
|
Number of patients with changes from baseline in vital signs |
Up to approximately 4 years
|
|
Concentration of daraxonrasib and zoldonrasib in Arm A
時間枠：Up to Cycle 5 Day 1 (each cycle is 28 days)
|
Pre-dose trough and post-dose blood concentrations of daraxonrasib and zoldonrasib at selected visits. |
Up to Cycle 5 Day 1 (each cycle is 28 days)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RMC-9805-309
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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