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A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Primary Purpose

Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Oral repotrectinib (TPX-0005)
Sponsored by
Turning Point Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Solid Tumors focused on measuring ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Documented genetic ALK, ROS1, or NTRK1-3 alteration (point mutation, fusion, amplification) as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
  2. Phase 1: Age <12 years; Phase 2: Age 12- 25 years
  3. Prior cytotoxic chemotherapy is allowed.
  4. Prior immunotherapy is allowed.
  5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology Criteria (RANO) criteria at time of enrollment.
  7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment.
  8. Subjects must have a Lansky (< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
  9. Life expectancy greater than or equal to 12 weeks.
  10. Adequate hematologic, renal and hepatic function.

Phase 2 Inclusion Criteria:

  1. Cohort Specific Inclusion Criteria:

    • Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;
    • Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;
    • Cohort 3: subjects with tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease or not otherwise eligible for Cohort 1 or 2.
  2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.

Key Exclusion Criteria (Phase 1 and Phase 2):

  1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
  2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
  3. Known active infections (bacterial, fungal, viral including HIV positivity).
  4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
  5. Any of the following cardiac criteria:

    • Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec)
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
  6. Peripheral neuropathy of CTCAE ≥grade 2.
  7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.

Sites / Locations

  • Children's Hospital Los AngelesRecruiting
  • University of California at Los AngelesRecruiting
  • Children's Hospital Colorado - Anschutz Medical CampusRecruiting
  • Arnold Palmer Hospital For ChildrenRecruiting
  • Maine Medical CenterRecruiting
  • Dana Farber Cancer Institute.Recruiting
  • Washington University School of Medicine in St. LouisRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Memorial Sloan-Kettering Cancer Center.Recruiting
  • Local Institution - 2112
  • Penn State Milton S. Hershey Medical CenterRecruiting
  • Children'S Hospital Of PhiladelphiaRecruiting
  • St. Jude Children's Research HospitalRecruiting
  • The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer CenterRecruiting
  • The University of Texas MD Anderson Cancer Center.Recruiting
  • Children's Hospital of Richmond at VCU
  • Local Institution - 6104Recruiting
  • Local Institution - 6103Recruiting
  • Local Institution - 6102Recruiting
  • Local Institution - 6101Recruiting
  • Local Institution - 2202Recruiting
  • Local Institution - 2201Recruiting
  • Local Institution - 4901Recruiting
  • Local Institution - 6111
  • Local Institution - 4203
  • Local Institution - 4201
  • Local Institution - 6110
  • Local Institution - 6112
  • Local Institution - 6109
  • Local Institution - 4202
  • Local Institution - 6108
  • Local Institution - 4301
  • Local Institution - 6113
  • Local Institution - 4302
  • Local Institution - 6114
  • Local Institution - 6303Recruiting
  • Local Institution - 6302Recruiting
  • Local Institution - 6304Recruiting
  • Local Institution - 6301Recruiting
  • Local Institution - 6401Recruiting
  • Local Institution - 6402Recruiting
  • Local Institution - 4104Recruiting
  • Local Institution - 6105
  • Local Institution - 4103
  • Local Institution - 6106
  • Local Institution - 4101Recruiting
  • Local Institution - 4102Recruiting
  • Local Institution - 6107
  • Local Institution - 6202Recruiting
  • Local Institution - 6201Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repotrectinib (TPX-0005)

Arm Description

Phase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ALK/ROS1/NTRK alterations or fusions in tumors and ALCL

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLTs) (Phase 1)
Define the dose limiting toxicities (DLTs) (Phase 1)
Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)
To determine the pediatric RP2D (Phase 1)
Overall Response Rate (ORR) (Phase 2)
To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)

Secondary Outcome Measures

Overall Response Rate (ORR) (Phase 1)
To determine the overall response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1)
Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)
To determine the CBR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)
Time to response (TTR) (Phase 1 and Phase 2)
To determine the TTR of reprotrectinib (TPX-005) (Phase 1 and Phase 2)
Duration of response (DOR) (Phase 1 and Phase 2)
To determine the DOR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)
Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2)
To determine the IC-ORR of repotrectinib (TPX-005) (Phase 1 and Phase 2)
Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)
CNS-PFS in subjects with measurable brain metastases (Phase 2)
Progression-free survival (PFS) (Phase 2)
To determine the PFS (Phase 2)
Overall survival (OS) (Phase 2)
To determine the OS (Phase 2)
Maximum concentration of repotrectinib in plasma (Cmax)
To determine the Cmax
Area under the concentration versus time curve of repotrectinib in plasma (AUC)
To determine the AUC

Full Information

First Posted
September 12, 2019
Last Updated
August 23, 2023
Sponsor
Turning Point Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04094610
Brief Title
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Official Title
A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
March 25, 2025 (Anticipated)
Study Completion Date
March 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turning Point Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric subjects with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations.
Detailed Description
Enrollment of subjects into Phase 1 will proceed concurrently by age as follows: Subjects <12 years old will initially be enrolled in the Phase 1 part to determine the pediatric RP2D for this age group; once the pediatric RP2D is determined, subjects age <12 years old may be enrolled into the Phase 2 part of the study. Subjects 12 to 25 years old will be directly enrolled into the Phase 2 part concurrent with Phase 1 enrollment. Phase 1: Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors, including a primary central nervous system (CNS) tumor, or anaplastic large cell lymphoma (ALCL), with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists. Phase 2: Subjects will be enrolled in one of 3 cohorts as follows: Cohort 1: approximately 10-20 subjects with solid tumors characterized by NTRK fusion, TRK tyrosine kinase inhibitor (TKI)-naïve, and centrally confirmed measurable disease at baseline. Cohort 2: approximately 23 subjects with solid tumors characterized by NTRK fusion, TRK TKI-pretreated, and centrally confirmed measurable disease at baseline. Cohort 3: approximately 20 subjects with solid tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease not otherwise eligible for Cohort 1 or 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
Keywords
ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repotrectinib (TPX-0005)
Arm Type
Experimental
Arm Description
Phase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ALK/ROS1/NTRK alterations or fusions in tumors and ALCL
Intervention Type
Drug
Intervention Name(s)
Oral repotrectinib (TPX-0005)
Other Intervention Name(s)
Oral repotrectinib (TPX-0005) capsules, Oral repotrectinib (TPX-0005) oral suspension, repotrectinib
Intervention Description
Oral repotrectinib (TPX-0005)
Primary Outcome Measure Information:
Title
Dose limiting toxicities (DLTs) (Phase 1)
Description
Define the dose limiting toxicities (DLTs) (Phase 1)
Time Frame
Within 28 days of the first repotrectinib dose
Title
Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)
Description
To determine the pediatric RP2D (Phase 1)
Time Frame
Within 28 days of the last patient dosed in escalation
Title
Overall Response Rate (ORR) (Phase 2)
Description
To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)
Time Frame
Two to three years after first dose of repotrectinib
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) (Phase 1)
Description
To determine the overall response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1)
Time Frame
Approximately three years
Title
Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)
Description
To determine the CBR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)
Time Frame
Approximately three years
Title
Time to response (TTR) (Phase 1 and Phase 2)
Description
To determine the TTR of reprotrectinib (TPX-005) (Phase 1 and Phase 2)
Time Frame
Approximately three years
Title
Duration of response (DOR) (Phase 1 and Phase 2)
Description
To determine the DOR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)
Time Frame
Approximately three years
Title
Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2)
Description
To determine the IC-ORR of repotrectinib (TPX-005) (Phase 1 and Phase 2)
Time Frame
Approximately three years
Title
Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)
Description
CNS-PFS in subjects with measurable brain metastases (Phase 2)
Time Frame
Approximately three years
Title
Progression-free survival (PFS) (Phase 2)
Description
To determine the PFS (Phase 2)
Time Frame
Approximately three years
Title
Overall survival (OS) (Phase 2)
Description
To determine the OS (Phase 2)
Time Frame
Approximately three years
Title
Maximum concentration of repotrectinib in plasma (Cmax)
Description
To determine the Cmax
Time Frame
Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days)
Title
Area under the concentration versus time curve of repotrectinib in plasma (AUC)
Description
To determine the AUC
Time Frame
Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Documented genetic ALK, ROS1, or NTRK1-3 alteration (point mutation, fusion, amplification) as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required. Phase 1: Age <12 years; Phase 2: Age 12- 25 years Prior cytotoxic chemotherapy is allowed. Prior immunotherapy is allowed. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology Criteria (RANO) criteria at time of enrollment. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment. Subjects must have a Lansky (< 16 years) or Karnofsky (≥ 16 years) score of at least 50. Life expectancy greater than or equal to 12 weeks. Adequate hematologic, renal and hepatic function. Phase 2 Inclusion Criteria: Cohort Specific Inclusion Criteria: Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve; Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated; Cohort 3: subjects with tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease or not otherwise eligible for Cohort 1 or 2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2): Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery. Known active infections (bacterial, fungal, viral including HIV positivity). Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. Any of the following cardiac criteria: Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval Peripheral neuropathy of CTCAE ≥grade 2. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-6062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Mascarenhas, Site 2111
Phone
323-361-5418
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Federman, Site 2109
Phone
310-206-7625
Facility Name
Children's Hospital Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Macy, Site 2108
Phone
720-777-8856
Facility Name
Arnold Palmer Hospital For Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Aguilar-Bonilla, Site 2105
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Chaleff, Site 2115
Facility Name
Dana Farber Cancer Institute.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Dubois, Site 2106
Phone
415-476-3831
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Cluster, Site 2113
Phone
443-745-4180
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Moerdler, Site 2110
Phone
000-000-0000
Facility Name
Memorial Sloan-Kettering Cancer Center.
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara O'Donohue, Site 2102
Facility Name
Local Institution - 2112
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Completed
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Brown, Site 2114
Phone
215-805-5247
Facility Name
Children'S Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Laetsch, Site 2117
Phone
214-771-6530
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Pappo, Site 2103
Phone
901-595-3300
Facility Name
The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Carens Watt, Site 2101
Facility Name
The University of Texas MD Anderson Cancer Center.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Gill, Site 2104
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 6104
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6104
Facility Name
Local Institution - 6103
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
0
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6103
Facility Name
Local Institution - 6102
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6102
Facility Name
Local Institution - 6101
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6101
Facility Name
Local Institution - 2202
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 2202
Facility Name
Local Institution - 2201
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 2201
Facility Name
Local Institution - 4901
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4901
Facility Name
Local Institution - 6111
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69008
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6111
Facility Name
Local Institution - 4203
City
Angers Cedex 1
ZIP/Postal Code
49033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4203
Facility Name
Local Institution - 4201
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4201
Facility Name
Local Institution - 6110
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6110
Facility Name
Local Institution - 6112
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6112
Facility Name
Local Institution - 6109
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6109
Facility Name
Local Institution - 4202
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4202
Facility Name
Local Institution - 6108
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6108
Facility Name
Local Institution - 4301
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4301
Facility Name
Local Institution - 6113
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6113
Facility Name
Local Institution - 4302
City
Rome
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4302
Facility Name
Local Institution - 6114
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6114
Facility Name
Local Institution - 6303
City
Seoul
State/Province
Seodaemun-gu
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6303
Facility Name
Local Institution - 6302
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6302
Facility Name
Local Institution - 6304
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6304
Facility Name
Local Institution - 6301
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6301
Facility Name
Local Institution - 6401
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6401
Facility Name
Local Institution - 6402
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6402
Facility Name
Local Institution - 4104
City
Madrid
State/Province
Boadilla Del Monte
ZIP/Postal Code
28660
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4104
Facility Name
Local Institution - 6105
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6105
Facility Name
Local Institution - 4103
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4103
Facility Name
Local Institution - 6106
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6106
Facility Name
Local Institution - 4101
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4101
Facility Name
Local Institution - 4102
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 4102
Facility Name
Local Institution - 6107
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6107
Facility Name
Local Institution - 6202
City
Taipei, Zhongzheng Dist.
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6202
Facility Name
Local Institution - 6201
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 6201

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share individual participant data with other researchers.
Citations:
PubMed Identifier
34814185
Citation
Wachter F, Al-Ibraheemi A, Trissal MC, Hollowell M, DuBois SG, Collins NB, Church AJ, Janeway KA. Molecular Characterization of Inflammatory Tumors Facilitates Initiation of Effective Therapy. Pediatrics. 2021 Dec 1;148(6):e2021050990. doi: 10.1542/peds.2021-050990.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

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