Trials / Recruiting
RecruitingNCT04511039
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
A Phase I Study of Trifluridine/ Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial investigates the side effects and best dose of talazoparib when given together with trifluridine/tipiracil for the treatment of patients with colorectal or gastroesophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Drugs used in the chemotherapy, such as trifluridine/tipiracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib with trifluridine/ tipiracil may inhibit certain enzymes in the cells that are responsible for tumor cell growth.
Detailed description
PRIMARY OBJECTIVE: I. To determine the safety, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of trifluridine and tipiracil hydrochloride (trifluridine/tipiracil \[FTD/TPI\]) in combination with talazoparib tosylate (talazoparib) in patients with advanced colorectal (CRC) or gastroesophageal (EGC) adenocarcinoma. SECONDARY OBJECTIVES: I. To determine the pharmacokinetics (PK) and pharmacodynamic (PD) markers of activity. II. To evaluate the preliminary antineoplastic efficacy of the combination.
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
| Type | Name | Description |
|---|---|---|
| DRUG | Trifluridine and Tipiracil Hydrochloride | Given PO |
| DRUG | Talazoparib Tosylate | Given PO |
Timeline
- Start date
- 2021-06-08
- Primary completion
- 2026-09-01
- Completion
- 2027-04-01
- First posted
- 2020-08-12
- Last updated
- 2026-03-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04511039. Inclusion in this directory is not an endorsement.