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

NCT04511039

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma, Clinical Stage IVBTrifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
NCT04511039
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • 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
Intervention  ICMJE
  • Drug: Trifluridine and Tipiracil Hydrochloride
    Given PO
    Other Names:
    • 733030-01-8
    • Lonsurf
    • TAS 102,
    • Thymidine
    • Tipiracil Hydrochlorid Mixture with Trifluridine
    • Trifluridine/Tipiracil
    • Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
  • Drug: Talazoparib Tosylate
    Given PO
    Other Name: Talzenna
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:
  • Drug: Trifluridine and Tipiracil Hydrochloride
  • Drug: Talazoparib Tosylate
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
 (submitted: August 10, 2020)
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:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christos Fountzilas, MD716-845-8974[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Christos Fountzilas, MDRoswell Park Cancer Institute
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