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Tyrosine Kinase Inhibitor

Talazoparib Combinations for Advanced Cancer

Phase 1

Recruiting

Led By Timothy A Yap

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status (PS) 0 to 1

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is to find the best dose of talazoparib to give with either palbociclib, axitinib, or crizotinib to patients with solid tumors that have spread. The goal is to see if the combination can help control the tumor growth.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who can swallow pills, have no allergies to study drugs, and are not pregnant. They must have specific gene defects related to cancer growth or DNA repair, adequate blood counts and organ function, and a performance status that allows daily activity. Patients with recent treatments or surgeries, uncontrolled infections like hepatitis B/C or HIV, brain metastases needing steroids, other recent malignancies (except prostate cancer in some cases), or those on strong CYP3A4 inhibitors/inducers cannot join.Check my eligibility

What is being tested?

The TalaCom Trial is testing the combination of talazoparib (a PARP inhibitor that prevents tumor cells from repairing their DNA) with either palbociclib, axitinib, or crizotinib (drugs that block enzymes needed for cell growth). The goal is to determine the best dose and see if this combo can control tumor growth better than current treatments.See study design

What are the potential side effects?

Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. There may also be liver issues indicated by changes in certain blood tests. Specific side effects depend on which drug combination patients receive but could involve high blood pressure with axitinib and vision disorders with crizotinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have at least one tumor that can be measured and has not been treated with radiation.

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My white blood cell count is healthy without needing medication or transfusions in the last 2 weeks.

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My cancer has a specific genetic change.

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My cancer has a specific change in the MET, ALK, or ROS1 gene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Incidence of dose limiting toxicities

Secondary outcome measures

Clinical benefit rate

Duration of response

Objective response

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (talazoparib, crizotinib)Experimental Treatment2 Interventions

Patients receive talazoparib PO QD on days 1-28 and crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may continue treatment even if there is progression of disease as long as the patient remains clinically stable, per the treating physician's discretion.

Group II: Arm II (talazoparib, axitinib)Experimental Treatment2 Interventions

Patients receive talazoparib PO QD on days 1-28 and axitinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may continue treatment even if there is progression of disease as long as the patient remains clinically stable, per the treating physician's discretion.

Group III: Arm I (talazoparib, palbociclib)Experimental Treatment2 Interventions

Patients receive talazoparib PO QD on days 1-21 or 1-28 and palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may continue treatment even if there is progression of disease as long as the patient remains clinically stable, per the treating physician's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Crizotinib

2014

Completed Phase 3

~2370

Talazoparib Tosylate

2015

Completed Phase 2

~30

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,205 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,570 Total Patients Enrolled

Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center

9 Previous Clinical Trials

425 Total Patients Enrolled

Media Library

Axitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04693468 — Phase 1

Cancer Research Study Groups: Arm I (talazoparib, palbociclib), Arm II (talazoparib, axitinib), Arm III (talazoparib, crizotinib)

Cancer Clinical Trial 2023: Axitinib Highlights & Side Effects. Trial Name: NCT04693468 — Phase 1

Axitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693468 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an innovative clinical trial?

"Currently, there are over two thousand seven hundred and eighty-nine energetic clinical trials for talazoparib tosylate across sixty countries and seventeen hundred seventy nine cities. The premier trial of its kind was launched in 2007 by Baxter Healthcare Corporation with 4640 participants; it achieved Phase 4 drug approval and has since seen 252 similar projects."

Answered by AI

Does this research endeavor offer opportunities for new participants?

"Indeed, clinicaltrials.gov lists this scientific trial as actively seeking participants since December 1st 2020 until the most recent update on November 16th 2021. 111 research subjects are required and only one location is necessary for enrolment."

Answered by AI

What is the ultimate goal of this clinical experiment?

"The purpose of this trial, evaluated on a timeline up to 30 days after the last dose is administered, is to measure the occurrence of dosage-limiting adverse reactions. Secondary objectives include assessing objective response (CR and PR per RECIST v1.1), progression free survival (estimated via Kaplan-Meier methods with 95% confidence intervals for response rate and binomial distributions) as well as plasma pharmacokinetic parameters such as peak concentration by treatment arm, cycle length and day number; tabulated numerical summary statistics will be provided along with individual graphs detailing each study drug's serum levels over time in logarithmic or linear scale"

Answered by AI

To what extent have prior investigations studied the efficacy of Talazoparib Tosylate?

"Currently, there are 289 ongoing trials with regards to Talazoparib Tosylate, including 29 that have progressed to Phase 3. While the major studies for this medication are based in Burgas, New jersey; globally 15576 sites are conducting research on it."

Answered by AI

How many participants will be taking part in this trial?

"Affirmative. According to the information stored on clinicaltrials.gov, this medical experiment, which was first introduced on December 1st 2020, is still enrolling participants. 111 individuals are required from a single site for successful testing completion."

Answered by AI

What medical issues has Talazoparib Tosylate been found to alleviate?

"Talazoparib Tosylate has been approved to treat brca1 gene mutation and may prove efficacious in the treatment of various medical afflictions such as breast cancer, renal failure, and malignant neoplasms."

Answered by AI