Locally Advanced Solid TumorPhase 1NCT05828277
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
A Phase 1 study testing repotrectinib (TPX-0005) in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Turning Point Therapeutics, Inc. at 2 sites in 2 countries.
Trial summary
This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Solid Tumor
- What is being tested?
- repotrectinib (TPX-0005)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jul 2022to 31 Dec 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 for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following:
- The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.
- The presence of liver lesion(s) (as defined in inclusion criteria 3a) with alphafetoprotein ≥ 400 ng/mL.
- Tissue confirmation.
- For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
- Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
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- Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
- The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.
- Patient with ascites must not have a paracentesis within 3 months of screening.
- Protocol specified baseline hematology and kidney function laboratory values
Who cannot join
- Concurrent participation in another therapeutic clinical study.
- Symptomatic brain metastases or leptomeningeal involvement.
- Major surgery within 4 weeks.
- Clinically significant cardiovascular disease.
- History of non-pharmacologically induced prolonged QT interval corrected for heart rate interval.
- Known active infections requiring ongoing treatment (bacterial, fungal, or viral, including human immunodeficiency virus positivity).
- Gastrointestinal disease or other malabsorption syndromes.
- Current use or anticipated need for drugs that are known to be strong cytochrome P450 (CYP) 3A inhibitors or inducers.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.
Read the detailed description
This is a Phase 1, multicenter, multiple-dose, open-label, nonrandomized study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib following single and multiple dose administration of repotrectinib in patients with advanced cancer. This study will enroll 8 patients each with moderate hepatic impairment, severe hepatic impairment and normal hepatic function.
- Being tested
- repotrectinib (TPX-0005)
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repotrectinib (TPX-0005)Drug
Also called Oral TPX-0005 capsules, repotrectinib
Oral repotrectinib (TPX-0005)
| Study group | Role | What they receive |
|---|---|---|
| Repotrectinib (TPX-0005) | Experimental | Oral repotrectinib (TPX-0005):
Cohort 1: Patients with moderate hepatic impairment Cohort 2: Patients with severe hepatic impairment Cohort 3: Patients with normal hepatic function Receives: Drug: repotrectinib (TPX-0005) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) of repotrectinib
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration
Measured: Within 22 days of first repotrectinib dose
Maximum Observed Plasma Concentration (Cmax) of repotrectinib
Cmax: Evaluate the maximum plasma concentration
Measured: Within 22 days of first Repotrectinib 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: 28 days after last dose of repotrectinib
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 start28 Jul 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 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 Locally 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
- NCT05828277
- Sponsor's protocol ID
- CA127-1026
- Other IDs
- CA127-1026, TPX-0005-15
- Status last verified
- Sep 2023
- First submitted
- 28 Mar 2023
- Last updated
- 26 Sep 2023
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT05828277
- Acronym / sponsor ID
- CA127-1026
- 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
- 28 Jul 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 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 effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.
Detailed description
This is a Phase 1, multicenter, multiple-dose, open-label, nonrandomized study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib following single and multiple dose administration of repotrectinib in patients with advanced cancer. This study will enroll 8 patients each with moderate hepatic impairment, severe hepatic impairment and normal hepatic function.
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: repotrectinib (TPX-0005)Oral repotrectinib (TPX-0005): Cohort 1: Patients with moderate hepatic impairment Cohort 2: Patients with severe hepatic impairment Cohort 3: Patients with normal hepatic function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following:
- For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
- Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
- Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
- The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.
Key exclusion criteria (8 listed)
- Concurrent participation in another therapeutic clinical study.
- Symptomatic brain metastases or leptomeningeal involvement.
- Major surgery within 4 weeks.
- Clinically significant cardiovascular disease.
- History of non-pharmacologically induced prolonged QT interval corrected for heart rate 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 |
|---|---|---|
| repotrectinib (TPX-0005)Also: Oral TPX-0005 capsules, repotrectinibOral repotrectinib (TPX-0005) | Drug | Repotrectinib (TPX-0005) |
Primary outcome
Area under the plasma concentration-time curve (AUC) of repotrectinib
Time frame: Within 22 days of first repotrectinib dose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration
Maximum Observed Plasma Concentration (Cmax) of repotrectinib
Time frame: Within 22 days of first Repotrectinib dose
Cmax: Evaluate the maximum plasma concentration
1 secondary outcome
Evaluate safety and tolerability
Time frame: 28 days after last dose of repotrectinib
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 26 Sep 2023.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing repotrectinib (TPX-0005) in people with Locally Advanced Solid Tumor and Metastatic Solid Tumor, run by Turning Point Therapeutics, Inc. at 2 sites in 2 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 10 inclusion and 8 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 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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 the plasma concentration-time curve (AUC) of repotrectinib (time frame: Within 22 days of first repotrectinib 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 26 Sep 2023.