Is NCT04511039 recruiting in Buffalo, NY?

Yes, NCT04511039 is currently recruiting participants at its Buffalo, NY location. This advanced malignant solid neoplasm clinical trial is actively enrolling qualified participants.

How do I join the advanced malignant solid neoplasm clinical trial in Buffalo?

To join this clinical trial in Buffalo, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Buffalo clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Malignant Solid Neoplasm Clinical Trial in Buffalo, NY

About This Advanced Malignant Solid Neoplasm Study in Buffalo

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.

Sponsor: Roswell Park Cancer Institute

Who Can Participate

Inclusion Criteria

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.

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 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 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

Radiotherapy within the past 2 weeks excluding palliative radiotherapy to painful bone lesions

Prior treatment with PARP inhibitor, FUDR 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 day -14 (Dose Escalation, Cohort A) or Cycle 1 Day 1 (Dose Expansion, Cohorts B1 and B2.

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

Any history of myelodysplastic syndrome, acute leukemia, or bone marrow transplant

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Buffalo?

Yes, this clinical trial (NCT04511039) has an active research site in Buffalo, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Malignant Solid Neoplasm Treatment Options in Buffalo, NY

If you're searching for advanced malignant solid neoplasm treatment options in Buffalo, NY, this clinical trial (NCT04511039) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Buffalo research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced advanced malignant solid neoplasm specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced malignant solid neoplasm clinical trials near you to find additional studies recruiting in your area.

Advanced Malignant Solid Neoplasm Clinical Trial in Buffalo, NY

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