Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pathologic Stage III Gastroesophageal Junction Adenocarcinoma
- Advanced Malignant Solid Neoplasm
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma
- Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma
- Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma
- Stage IVC Colorectal Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma
- Stage IIIB Colorectal Cancer AJCC v8
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma
- Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A
- Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma
- Stage III Colorectal Cancer AJCC v8
- Locally Advanced Colorectal Carcinoma
- Stage IIIC Colorectal Cancer AJCC v8
- Locally Advanced Gastroesophageal Junction Adenocarcinoma
- Metastatic Colorectal Adenocarcinoma
- Stage IVA Colorectal Cancer AJCC v8
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma
- Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 gastroe...
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.
Tracking Information
- NCT #
- NCT04511039
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: Christos Fountzilas, MD Roswell Park Cancer Institute
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