Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05828303




Registration number
NCT05828303
Ethics application status
Date submitted
28/03/2023
Date registered
25/04/2023
Date last updated
14/08/2024

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
Scientific title
A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements
Secondary ID [1] 0 0
CA127-1027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - TPX-0005
Treatment: Drugs - Metformin Hydrochloride
Treatment: Drugs - Digoxin
Treatment: Drugs - Rosuvastatin Calcium

Experimental: Repotrectinib (TPX-0005) - Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)


Treatment: Drugs: TPX-0005
Oral TPX-0005 capsules

Treatment: Drugs: Metformin Hydrochloride
oral solution

Treatment: Drugs: Digoxin
oral tablet

Treatment: Drugs: Rosuvastatin Calcium
oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under plasma-concentration time curve
Timepoint [1] 0 0
Within 28 days of first cocktail dose
Primary outcome [2] 0 0
Maximum Observed Plasma Concentration
Timepoint [2] 0 0
Within 28 days of first cocktail dose
Secondary outcome [1] 0 0
Evaluate safety and tolerability
Timepoint [1] 0 0
Within 28 days of first cocktail dose

Eligibility
Key inclusion criteria
Key

1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary central nervous system [CNS] tumors) that harbors a ROS1 or NTRK1-3 gene fusion.
2. Patient must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (= 18 years).
4. Protocol specified baseline hematology, liver function and kidney function laboratory values.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concurrent participation in another therapeutic clinical trial.
2. Symptomatic brain metastases or leptomeningeal involvement.
3. Major surgery within 4 weeks of start of repotrectinib treatment.
4. Clinically significant cardiovascular disease.
5. History of non-pharmacologically induced prolonged QTc interval
6. Known active infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity).
7. Gastrointestinal disease or other malabsorption syndromes.
8. Current or anticipated use of drugs that are known to be moderate or strong CYP3A inhibitors or inducers.
9. Patients who have received, or are expected to receive metformin, digoxin or rosuvastatin within 14 days prior to beginning of the DDI assessment period.
10. Patients who have received or are expected to receive drugs that are inhibitors of P-gp, OATP1B1, BCRP, and MATE2-K within 14 days or 5 half-lives (whichever is longer) prior to beginning of the DDI assessment period until the DDI assessment period is completed.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 2119 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 2131 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Brazil
State/province [4] 0 0
RJ
Country [5] 0 0
Brazil
State/province [5] 0 0
RS
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
La Tronche
Country [10] 0 0
France
State/province [10] 0 0
Marseille
Country [11] 0 0
France
State/province [11] 0 0
Nantes
Country [12] 0 0
France
State/province [12] 0 0
Poitiers
Country [13] 0 0
France
State/province [13] 0 0
Saint-Herblain
Country [14] 0 0
Italy
State/province [14] 0 0
MI
Country [15] 0 0
Italy
State/province [15] 0 0
PG
Country [16] 0 0
Italy
State/province [16] 0 0
PN
Country [17] 0 0
Italy
State/province [17] 0 0
SI
Country [18] 0 0
Italy
State/province [18] 0 0
VR
Country [19] 0 0
Italy
State/province [19] 0 0
Naples
Country [20] 0 0
Spain
State/province [20] 0 0
B
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
M
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Pamplona
Country [25] 0 0
Spain
State/province [25] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Turning Point Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05828303