Advanced Solid TumorPhase 1NCT05828303
A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
A Phase 1 study testing TPX-0005, Metformin Hydrochloride and Digoxin in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Turning Point Therapeutics, Inc. at 33 sites in 6 countries.
Trial summary
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- TPX-0005, Metformin Hydrochloride and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 15 Nov 2024to 30 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (≥ 18 years).
- Protocol specified baseline hematology, liver function and kidney function laboratory values.
Who cannot join
- Concurrent participation in another therapeutic clinical trial.
- Symptomatic brain metastases or leptomeningeal involvement.
- Major surgery within 4 weeks of start of repotrectinib treatment.
- Clinically significant cardiovascular disease.
- History of non-pharmacologically induced prolonged QTc interval
- Known active infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity).
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- Gastrointestinal disease or other malabsorption syndromes.
- Current or anticipated use of drugs that are known to be moderate or strong CYP3A inhibitors or inducers.
- Patients who have received, or are expected to receive metformin, digoxin or rosuvastatin within 14 days prior to beginning of the DDI assessment period.
- 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.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Spain12 sites
Local Institution - 2124
Barcelona, B, 08003
Local Institution - 2113
Barcelona, B, 08025
Local Institution - 2105
Barcelona, B, 8035
Local Institution - 2109
Barcelona, 8950
Local Institution - 2138
Madrid, M, 28027
Local Institution - 2110
Madrid, M, 28034
Local Institution - 2128
Madrid, M, 28040
Local Institution - 2127
Madrid, 28033
Local Institution - 2106
Madrid, 28040
Local Institution - 2112
Pamplona, 31008
Local Institution - 2129
Pozuelo de Alarcón, Madrid, 28223
Local Institution - 2125
Valencia, 46009
France7 sites
Local Institution - 2123
Bordeaux, 33076
Local Institution - 2122
La Tronche, 38700
Local Institution - 2117
Marseille, 13915
Local Institution - 2115
Nantes, 44093
Local Institution - 2121
Poitiers, 86021
Local Institution - 2136
Rennes, 35000
Local Institution - 2120
Saint-Herblain, 44805
Italy6 sites
Local Institution - 2104
Aviano, PN, 33081
Local Institution - 2135
Milan, MI, 20132
Local Institution - 2114
Naples, 80131
Local Institution - 2111
Perugia, PG, 06129
Local Institution - 2116
Rozzano, MI, 20089
Local Institution - 2103
Verona, VR, 37134
Brazil5 sites
Local Institution - 2126
Botafogo, Rio de Janeiro, 22281100
Local Institution - 2132
Porto Alegre, Rio Grande do Sul, 90050-170
Local Institution - 2134
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution - 2130
São Paulo, São Paulo, 1308050
Local Institution - 2108
São Paulo, 01246-000
United States2 sites
Gabrail Cancer Research Center
Canton, Ohio, 44718
Local Institution - 2101
Canton, Ohio, 44718
About this study
Official 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
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
Read the detailed description
This is a Phase 1, open-label, fixed-sequence study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on drug transporters (metformin, digoxin and rosuvastatin) following multiple dose administration of repotrectinib in patients with advanced cancer harboring ROS1 and NTRK1 Rearrangements.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Being tested
- TPX-0005, Metformin Hydrochloride, Digoxin, Rosuvastatin Calcium
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-0005Drug
Also called repotrectinib
Oral TPX-0005 capsules
Metformin HydrochlorideDrug
Also called Glucophage, Metabet, Glucient, Diagemet
oral solution
DigoxinDrug
Also called Lanoxin
oral tablet
Rosuvastatin CalciumDrug
Also called Crestor
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Repotrectinib (TPX-0005) | Experimental | Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium) Receives: Drug: TPX-0005; Drug: Metformin Hydrochloride; Drug: Digoxin; Drug: Rosuvastatin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma-concentration time curve
AUC0-t: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration. AUC0-inf: area under the plasma-concentration time curve from time 0 to infinity (if data permit).
Measured: Within 28 days of first cocktail dose
Maximum Observed Plasma Concentration
Cmax: maximum observed plasma concentration
Measured: Within 28 days of first cocktail dose
Secondary outcomes (1)
Evaluate safety and tolerability
To evaluate the safety and tolerability of repotrectinib in patients with moderate and severe hepatic impairment and patients with normal hepatic function following single and multiple dose administration of repotrectinib assessed by CTCAE v5.0
Measured: Within 28 days of first cocktail dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Nov 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turning Point Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828303
- Sponsor's protocol ID
- CA127-1027
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05828303
- Acronym / sponsor ID
- CA127-1027
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Turning Point Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
Detailed description
This is a Phase 1, open-label, fixed-sequence study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on drug transporters (metformin, digoxin and rosuvastatin) following multiple dose administration of repotrectinib in patients with advanced cancer harboring ROS1 and NTRK1 Rearrangements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repotrectinib (TPX-0005) | Experimental | Drug: TPX-0005, Drug: Metformin Hydrochloride, Drug: Digoxin, Drug: Rosuvastatin CalciumPhase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Patient must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (≥ 18 years).
- Protocol specified baseline hematology, liver function and kidney function laboratory values.
Key exclusion criteria (10 listed)
- Concurrent participation in another therapeutic clinical trial.
- Symptomatic brain metastases or leptomeningeal involvement.
- Major surgery within 4 weeks of start of repotrectinib treatment.
- Clinically significant cardiovascular disease.
- History of non-pharmacologically induced prolonged QTc interval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPX-0005Also: repotrectinibOral TPX-0005 capsules | Drug | Repotrectinib (TPX-0005) |
| Metformin HydrochlorideAlso: Glucophage, Metabet, Glucient, Diagemetoral solution | Drug | Repotrectinib (TPX-0005) |
| DigoxinAlso: Lanoxinoral tablet | Drug | Repotrectinib (TPX-0005) |
| Rosuvastatin CalciumAlso: Crestororal tablet | Drug | Repotrectinib (TPX-0005) |
Primary outcome
Area under plasma-concentration time curve
Time frame: Within 28 days of first cocktail dose
AUC0-t: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration. AUC0-inf: area under the plasma-concentration time curve from time 0 to infinity (if data permit).
Maximum Observed Plasma Concentration
Time frame: Within 28 days of first cocktail dose
Cmax: maximum observed plasma concentration
1 secondary outcome
Evaluate safety and tolerability
Time frame: Within 28 days of first cocktail dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPX-0005, Metformin Hydrochloride and Digoxin in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Turning Point Therapeutics, Inc. at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, France, Italy, Brazil, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma-concentration time curve (time frame: Within 28 days of first cocktail dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.