RECRUITING

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

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Conditions

Advanced Malignant Solid NeoplasmClinical Stage III Gastroesophageal Junction AdenocarcinomaClinical Stage IV Gastroesophageal Junction AdenocarcinomaClinical Stage IVA Gastroesophageal Junction AdenocarcinomaClinical Stage IVB Gastroesophageal Junction Adenocarcinoma ALocally Advanced Colorectal CarcinomaLocally Advanced Gastroesophageal Junction AdenocarcinomaMetastatic Colorectal AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaPathologic Stage III Gastroesophageal Junction AdenocarcinomaPathologic Stage IIIA Gastroesophageal Junction AdenocarcinomaPathologic Stage IIIB Gastroesophageal Junction AdenocarcinomaPathologic Stage IV Gastroesophageal Junction AdenocarcinomaPathologic Stage IVA Gastroesophageal Junction AdenocarcinomaPathologic Stage IVB Gastroesophageal Junction AdenocarcinomaPostneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Stage III Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of Trifluridine/ Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers

Quick Facts

Study Start:2021-06-08
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04511039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed CRC or EGC adenocarcinoma that is locally advanced or metastatic (Cohort A); histologically or cytologically confirmed p53mt/RASonc (Cohort B1) or p53mt/RASwt CRC (Cohort B2) that is locally advanced or metastatic. Patients with adenocarcinoma histology only are allowed to participate.
  2. * Has received at least one prior line of therapy with progression or intolerance
  3. * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
  4. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  5. * Life expectancy \>= 3 months by investigator assessment
  6. * Hemoglobin \>= 9 g/dL
  7. * Absolute neutrophil count \>= 1500/mm\^3
  8. * Platelet count \>= 100,000/mm\^3 without transfusion or growth factor support
  9. * Creatinine \< 1.5 upper limit of normal (ULN) or creatinine clearance \> 60 mL/min
  10. * Total bilirubin \< 1.5 x ULN
  11. * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN or \< x 5 ULN in the presence of liver metastasis
  12. * Albumin \> 3 g/dL
  13. * Ability to swallow oral medications
  14. * 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
  15. * Participant 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
  1. * Systemic antineoplastic therapy within 2 weeks prior to day -14 (Dose Escalation, Cohort A) or Cycle 1 day 1 (Dose Expansion, Cohorts B1 and B2) or within the past 6 weeks if this treatment is mitomycin C or nitrosourea
  2. * Radiotherapy within the past 2 weeks excluding palliative radiotherapy to painful bone lesions
  3. * Prior treatment with PARP inhibitor or FTD/TPI
  4. * Any condition that in the investigator's opinion can limit absorption of FTD/TPI or talazoparib from the gastrointestinal (GI) tract
  5. * Gastrointestinal obstruction (without diversion) or perforation within 4 weeks from initiation of day -14 (Dose Escalation, Cohort A) or Cycle 1 Day 1 (Dose Expansion, Cohorts B1 and B2.
  6. * Refractory ascites (requiring weekly or more frequent paracentesis or permanent indwelling peritoneal catheter)
  7. * 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
  8. * 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
  9. * Other malignancy requiring active therapy
  10. * Presence of toxicities from prior therapy of grade 2 or higher
  11. * Active infection requiring antibiotic therapy
  12. * 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
  13. * Any history of myelodysplastic syndrome, acute leukemia, or bone marrow transplant
  14. * Pregnant or nursing female participants
  15. * Unwilling or unable to follow protocol requirements
  16. * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Contacts and Locations

Study Contact

Sarah Chatley, BS
CONTACT
716-845-4846
Sarah.Chatley@roswellpark.org

Principal Investigator

Christos Fountzilas, MD
PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute
Buffalo, New York, 14263
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Christos Fountzilas, MD, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-08
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2021-06-08
Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • 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