Trial · NCT04511039
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
NCT04511039, Phase 1, Recruiting, Roswell Park Cancer Institute
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer. Trials, record NCT04511039. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04511039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
- NCT number
- NCT04511039
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 45 participants, estimated
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Advanced Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A, Locally Advanced Colorectal Carcinoma, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma, Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma, Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma, Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
- Interventions
- Trifluridine and Tipiracil Hydrochloride, Talazoparib Tosylate
- First posted
- 2020-08-12
- Last updated
- 2026-05-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | after each cycle of treatment ( 1 cycle = 14 days) | All adverse events will be evaluated using Common Terminology Criteria for All Adverse Events (CTCAE) version (v.) 5. |
| Primary | Maximum tolerated dose/ recommended phase II dose | Up to 14 days | Will utilize the keyboard design - a novel model- assisted dose-finding method to find the maximum tolerated dose |
| Secondary | Plasma Concentration (Cmax) | Day -13 post dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Plasma Concentration (Cmax) | day -14 pre dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Plasma Concentration (Cmax) | day -14 post dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Plasma Concentration (Cmax) | day -13 pre dose | The pharmacokinetic parameters between Trifluridine/Tipiracil and Talazoparib will be evaluated on Day -14: pre-dose, 0.5, 1, 2, 4, 6, 8 hours (hr) post-dose; day-13: 24 hr post-initial dose and day -13 pre-dose |
| Secondary | Overall Response Rate (ORR) | Up to 3 years | Will be summarized using frequencies and relative frequencies. |
| Secondary | CEA response rate (colorectal cancer patients) | Up to 3 years | ill be summarized using frequencies and relative frequencies. . |
| Secondary | Progression Free Survival (PFS) | From treatment until disease progression UP to 3 years | Will be summarized using standard Kaplan-Meier methods |
| Secondary | Overall Survival (OS) | From treatment until death or up to 3 years | Will be summarized using standard Kaplan-Meier methods |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R37CA282430 | Novel synthetic lethality strategy for TP53 mutant colorectal cancer | FOUNTZILAS, CHRISTOS | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 2023 to 2025 |
Source NIH RePORTER
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/NCT04511039
GET https://conductscience.org/api/trials/v1/NCT04511039/registered