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治験 NCT02650401 (STARTRK-NG)（対象：固形腫瘍、中枢神経系腫瘍）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ロシュStudy Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options (STARTRK-NG) 第I相・フェーズ1, 第II相・フェーズ2 69 用量漸増 小児 思春期 非盲検
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT02650401 (STARTRK-NG) は 固形腫瘍、中枢神経系腫瘍 に関する 治療 の研究で、第I相・フェーズ1 第II相・フェーズ2 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2016年5月3日 から開始しています。69 名の参加者 の募集が計画されています。この試験は ロシュ によって主導され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月25日 です。
概要
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.
公式タイトル
A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
疾患名
固形腫瘍中枢神経系腫瘍刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- STARTRK-NG
- RXDX-101-03
- CO40778 (その他の識別子) (Hoffmann-La Roche)
- 2023-505088-35-00 (EU試験（CTIS）番号)
NCT番号
開始日
2016-05-03
最終更新日
2026-03-25
終了予定日
2026-06-30
目標参加者数
69
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
第II相・フェーズ2
第II相・フェーズ2
状況
実施中／登録終了
キーワード
TRK
Tyrosine kinase
NTRK
NTRK1
NTRK2
NTRK3
ROS1
ALK
Pediatric
Relapsed
Refractory
Solid Tumor
Metastatic Cancer
Gene rearrangement
Neuroblastoma
Infantile fibrosarcoma
Secretory breast cancer
Congenital mesoblastic nephroma
Pontine glioma
Brain tumors
CNS tumors
Sarcoma
Ewing sarcoma
Glial tumors
Salivary Gland Cancer (MASC)
Papillary thyroid cancer
Medulloblastoma
Wilms tumor (anaplastic)
Tyrosine kinase
NTRK
NTRK1
NTRK2
NTRK3
ROS1
ALK
Pediatric
Relapsed
Refractory
Solid Tumor
Metastatic Cancer
Gene rearrangement
Neuroblastoma
Infantile fibrosarcoma
Secretory breast cancer
Congenital mesoblastic nephroma
Pontine glioma
Brain tumors
CNS tumors
Sarcoma
Ewing sarcoma
Glial tumors
Salivary Gland Cancer (MASC)
Papillary thyroid cancer
Medulloblastoma
Wilms tumor (anaplastic)
主目的
治療
割付方法
非無作為化
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬Extracranial solid tumors harboring NTRK1/2/3, Arm closed for further enrollment
ROS1, ALK non-gene fusion molecular alterations
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
実薬対照薬CNS tumors harboring- NTRK1/2/3, ROS1, ALK Arm closed for further enrollment
molecular alterations, including gene fusions
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
実薬対照薬Neuroblastoma Arm closed for further enrollment
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
実薬対照薬Non-neuroblastoma, extracranial solid tumors Arm closed for further enrollment
harboring - NTRK1/2/3, ROS1, ALK gene fusions
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
実薬対照薬Any participant unable to swallow capsules Arm closed for further enrollment
Any participant who otherwise meet all other eligibility criteria
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
実薬対照薬Expansion: CNS tumors harboring NTRK1/2/3, ROS1 gene fusions
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
実薬対照薬Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1 NTRK 1,2,3 and ROS1 fusions
Oral entrectinib (RXDX-101) | Entrectinib TRKA/B/C, ROS1, and ALK inhibitor |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Maximum Tolerated Dose (MTD) | Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03) | Approximately 6 months |
Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules | Assessed by NCI CTCAE v4.03 | Approximately 6 months |
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules | Assessed by NCI CTCAE v4.03 | Approximately 6 months |
Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube) | Assessed by NCI CTCAE v4.03 | Approximately 6 months |
Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules | Assessed by NCI CTCAE v4.03 | Approximately 6 months |
Cohort B: Objective Response Rate (ORR) | Assessed by RANO per the BICR | Approximately 6 months |
Cohort D: ORR | Assessed by RECIST v1.1 per the BICR | Approximately 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03 | AE, ECG and Labs assessed by NCI CTCAE v4.03 | Approximately 24 months |
Maximum observed plasma drug concentration (Cmax) using F1 Formulation | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Maximum observed plasma drug concentration (Cmax) using minitablets/F15 | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Time to Cmax, by inspection (Tmax) using F1 Formulation | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Time to Cmax, by inspection (Tmax) using F06 Formulation given intact | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Time to Cmax, by inspection (Tmax) using minitablets/F15 | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
AUC at steady state (AUCss) using F1 Formulation | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
AUC at steady state (AUCss) using F06 Formulation given intact | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
AUC at steady state (AUCss) using F06 Formulation administered via feeding tube | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
AUC at steady state (AUCss) using minitablets/F15 | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Terminal half life (t½) using F1 Formulation | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Terminal half life (t½) using F06 Formulation given intact | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Terminal half life (t½) using F06 Formulation administered via feeding tube | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Terminal half life (t½) using minitablets/F15 | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Area under the drug concentration by time curve (AUC) using F1 Formulation | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Area under the drug concentration by time curve (AUC) using F06 Formulation given intact | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Area under the drug concentration by time curve (AUC) using F06 Formulation administered via feeding tube | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Area under the drug concentration by time curve (AUC) using minitablets/F15 | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter | Approximately 24 months |
Cohort A, D, or E: Clinical Benefit Rate (CBR) | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Cohort B or E: CBR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Cohort C: CBR | Assessed by the Curie scale per the BICR and investigator | Approximately 6 months |
Cohort A, D, or E: Progression-free Survival (PFS) | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Cohort B or E: PFS | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Cohort C: PFS | Assessed by the Curie scale per the BICR and investigator | Approximately 6 months |
Cohort A, D, or E: Overall Survival (OS) | Assessed by RECIST v1.1 | Approximately 6 months |
Cohort B or E: OS | Assessed by RANO | Approximately 6 months |
Cohort A, D, or E: ORR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Cohort B or E: ORR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Cohort C: ORR | Assessed by the Curie scale per the BICR and investigator | Approximately 6 months |
Cohort A, D, or E: Time to response (TTR) | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Cohort B or E: TTR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Cohort C: TTR | Assessed by the Curie scale per the BICR and investigator | Approximately 6 months |
Cohort A, D, or E: Duration of Response (DOR) | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Cohort B or E: DOR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Cohort C: DOR | Assessed by the Curie scale per the BICR and investigator | Approximately 6 months |
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR | Assessed by RANO per the investigator | Approximately 6 months |
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): ORR | Assessed by RECIST v1.1 per the investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): ORR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): ORR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): ORR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): ORR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): ORR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): ORR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): DOR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): DOR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): DOR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): DOR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): DOR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): DOR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): DOR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort D or E): TTR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort A, D, or E): TTR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 gene fusions (Cohort B or E): TTR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with ROS1 gene fusions (Cohort A, D, or E): TTR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with ROS1 gene fusions (Cohort B or E): TTR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort A, D, or E): TTR | Assessed by RECIST v1.1 per the BICR and investigator | Approximately 6 months |
Phase 1/2 Participants with NTRK1/2/3 or ROS1 gene fusions (Cohort B or E): TTR | Assessed by RANO per the BICR and investigator | Approximately 6 months |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
0 Years
対象性別
全て
Disease status:
Phase 1 portion (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1
Phase 2 portion:
- Part B: Participants must have measurable or evaluable disease, as defined by RANO
- Part C (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale
- Part D: Participants must have measurable or evaluable disease, as defined by RECIST v1.1
- Part E (closed): Participants must have measurable or evaluable disease, as defined by RECIST v1.1 ± Curie Scale or RANO
Tumor type:
Phase 1 portion:
* Part A: Relapsed or refractory extracranial solid tumors
Phase 2 portion
- Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method
- Part D: Extracranial solid tumors (including NB) with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method
Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
Archival tumor tissue from diagnosis or, preferably, at relapse
Performance status: Lansky or Karnofsky score ≥ 60% and minimum life expectancy of at least 4 weeks
Prior therapy: Participants must have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options for solid tumors and primary CNS tumors that are neurotrophic tyrosine receptor kinase (NTRK) or ROS1 fusion-positive
Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment
Adequate organ and neurologic function
Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Agreement to remain abstinent or use use combined contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment.
For male participants with a female partner of childbearing potential or a pregnant female partner: Agreement to remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of study drug
- Receiving other experimental therapy
- Known congenital long QT syndrome
- History of recent (3 months) symptomatic congestive heart failure or ejection fraction ≤50% at screening
- Known active infections
- Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia
- Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.
- Prior treatment with approved or investigational TRK or ROS1 inhibitors
- Known hypersensitivity to entrectinib or any of the other excipients of the investigational medicinal product
- Patients with NB with bone marrow space-only disease
- Incomplete recovery from acute effects of any surgery prior to treatment.
- Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
- Other severe acute or chronic medical or psychiatric condition or lab abnormality that may increase the risk associated with study participation, drug administration or may interfere with the interpretation of study results.
ロシュ連絡先情報がありません。
26 9カ国の場所
California
University of California San Diego, La Jolla, California, 92093-0706, United States
UCSF Benioff Children's Hospital, San Francisco, California, 94158, United States
Colorado
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
Georgia
Egleston Children's Hospital at Emory University Atlanta, Atlanta, Georgia, 30322, United States
Illinois
University of Chicago, Chicago, Illinois, 60637, United States
Maryland
Johns Hopkins University, Baltimore, Maryland, 21205, United States
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Missouri
Washington University,St. Louis Children's Hospital, St Louis, Missouri, 63110, United States
New York
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Ohio
Nationwide Children's Hospital, Columbus, Ohio, 43205, United States
Oregon
Oregon Health & Science Uni, Portland, Oregon, 97239, United States
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Tennessee
St. Jude Children'S Research Hospital, Memphis, Tennessee, 38105, United States
Texas
Texas Children's Cancer and Hematology Center, Houston, Texas, 77030, United States
Utah
Primary Children's Hospital, Salt Lake City, Utah, 84113, United States
Ontario
The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada
Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, 200082, China
Beijing Children's Hospital, Capital Medical University, Beijing, China
Centre Leon Berard, Lyon, 69373, France
Hôpital de la Timone, Oncologie Pédiatrique, Marseille, 13385, France
Baden-Wurttemberg
Universitaetsklinikum Heidelberg, Heidelberg, Baden-Wurttemberg, 69120, Germany
Hong Kong Children's Hospital, Hong Kong, 00000, Hong Kong
Lombardy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Lombardy, 20133, Italy
Hospital Infantil Universitario Nino Jesus, Madrid, 28009, Spain
Royal Marsden Hospital (Sutton), London, SW3 6JJ, United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP, United Kingdom