Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
NCT04511039
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- Histologically or cytologically confirmed CRC or EGC adenocarcinoma that is locally advanced or metastatic
- Has received at least one prior line of therapy with progression or intolerance
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy >= 3 months by investigator assessment
- Hemoglobin >= 9 g/dL
- Absolute neutrophil count >= 1500/mm^3
- Platelet count >= 100,000/mm^3 without transfusion or growth factor support
- Creatinine < 1.5 upper limit of normal (ULN) or creatinine clearance > 60 mL/min
- Total bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN or < x 5 ULN in the presence of liver metastasis
- Albumin > 3 g/dL
- Ability to swallow oral medications
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Systemic antineoplastic therapy within 2 weeks prior to initiation of FTD/TPI run-in
phase (within the past 6 weeks if this treatment is mitomycin C or nitrosourea)
- Radiotherapy within the past 2 weeks excluding palliative radiotherapy to painful bone
lesions
- Prior treatment with PARP inhibitor or FTD/TPI
- Any condition that in the investigator's opinion can limit absorption of FTD/TPI or
talazoparib from the gastrointestinal (GI) tract
- Gastrointestinal obstruction (without diversion) or perforation within 4 weeks from
initiation of FTD/TPI run-in
- Refractory ascites (requiring weekly or more frequent paracentesis or permanent
indwelling peritoneal catheter)
- Untreated central nervous system (CNS) disease. Patients with leptomeningeal disease
are ineligible but patients with treated, stable CNS metastasis for at least 4 weeks
are allowed to participate
- Significant cardiac disease defined as congestive heart failure stage III or IV (New
York Heart Association [NYHA]), acute coronary event, cerebrovascular event,
peripheral arterial embolic event, venous thromboembolic event (pulmonary embolism or
lower extremity deep vein thrombosis), or ventricular arrhythmia within the past 3
months
- Other malignancy requiring active therapy
- Presence of toxicities from prior therapy of grade 2 or higher
- Active infection requiring antibiotic therapy
- Known human immunodeficiency virus (HIV) or hepatitis B infection or untreated
hepatitis C infection. Patients with treated hepatitis C infection and undetectable
viral load are allowed to participate
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable
candidate to receive study drug
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| Descriptive Information | |||||
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| Brief Title ICMJE | Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer | ||||
| Official Title ICMJE | A Phase I Study of Trifluridine/ Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers | ||||
| Brief 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Treatment Arm
Patients receive trifluridine/tipiracil PO BID and talazoparib tosylate PO QD on days 1-5. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Interventions:
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| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 21 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 1, 2022 | ||||
| Estimated Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04511039 | ||||
| Other Study ID Numbers ICMJE | I 650120 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Roswell Park Cancer Institute | ||||
| Study Sponsor ICMJE | Roswell Park Cancer Institute | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| PRS Account | Roswell Park Cancer Institute | ||||
| Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||