Trial · NCT03093116
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
NCT03093116, Phase 1, Phase 2, Recruiting, Turning Point Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements. Trials, record NCT03093116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03093116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
- NCT number
- NCT03093116
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Turning Point Therapeutics, Inc.
- Conditions
- Locally Advanced Solid Tumors, Metastatic Solid Tumors
- Interventions
- Oral repotrectinib (TPX-0005)
- First posted
- 2017-03-28
- Last updated
- 2026-05-27
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicities (DLTs) (Phase 1) | Within 28 days of the first repotrectinib dose | Define the dose limiting toxicities (DLTs) (Phase 1) |
| Primary | Recommended Phase 2 Dose (RP2D) (Phase 1) | Within 28 days of the last patient dosed in escalation | To determine the RP2D (Phase 1) |
| Primary | Overall Response Rate (ORR) Phase 2 | Two to three years after first dose of repotrectinib dose | To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2) |
| Secondary | Maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) |
| Secondary | Area under the plasma concentration time curve (AUC) of repotrectinib (TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the area under the plasma concentration time curve (AUC) of repotrectinib |
| Secondary | Area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) |
| Secondary | Maximum plasma concentration (CMAX) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) | Up to 72 hours post dose | To determine the maximum plasma concentration (CMAX) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1) |
| Secondary | Area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1) | Up to 24 hours post dose | To determine the area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1) |
| Secondary | Maximum plasma concentration (CMAX) of midazolam(TPX-0005) (Phase 1) | Up to 24 hours post dose | To determine the maximum plasma concentration (CMAX) of midazolam(TPX-0005) (Phase 1) |
| Secondary | Plasma concentration of repotrectinib following administration at RP2D (Phase 2) | Pre dose and 4 hours post dose | To evaluate the plasma concentration of repotrectinib following administration at RP2D (Phase 2) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03093116
GET https://conductscience.org/api/trials/v1/NCT03093116/registered