Talazoparib with Palbociclib, Axitinib, or Crizotinib for Advanced Solid Tumors
This study is testing different combinations of medicines for advanced or metastatic (spread to other parts of the body) solid tumors. It aims to find the best dose and understand the possible benefits and side effects of talazoparib when given with palbociclib, axitinib, or crizotinib. Talazoparib works by stopping PARP proteins, which help repair damaged tumor cell DNA, from working. Palbociclib, axitinib, and crizotinib may also stop tumor cells from growing. You may be able to join if you have a specific gene defect in DNA Damage Response (DDR) genes like BRCA1 or PALB2, or other related genes. The main goal is to see how safe these combinations are and what side effects they cause. This study is currently unclear on its recruitment status and plans to enroll 111 participants.
- Study design
- This is a Phase 1 study designed to find the best dose of talazoparib when combined with palbociclib, axitinib, or crizotinib. It plans to enroll 111 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 30 days after your last study medication dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04693468
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~111 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:AxitinibCrizotinibPalbociclib IsethionateTalazoparib Tosylate
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 30 days after the last investigational product administration
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Timothy A Yap · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Defect in DNA Damage Response (DDR) genes specified below for each cohort or other related genes at the discretion of the principal investigator in consultation with the MD Anderson Cancer Center Institute for Personalized Cancer Therapy Precision Oncology Decision Support (PODS) group. See below for additional eligibility guidance for Arms A - C:
Eligibility for Arm A (Talazoparib + Palbociclib):
Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigator, or
MYC-aberrant solid tumors (e.g. overexpression, amplification, mutation)
Eligibility for Arm B (Talazoparib + Axitinib):
Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigator, or
Participants with BRCA1/2 wild-type high-grade serous ovarian cancer, or
Participants with metastatic castration-resistant prostate cancer without a specific and/or selected mutation
Eligibility for Arm C (Talazoparib + Crizotinib):
Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2,36 RAD51C/D, or other related genes at the discretion of the principal investigator, or
Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations) NOTE: Participants who are eligible for more than one Arm will be assigned according to physician preference. 2. Histological or cytological diagnosis of a solid tumor that is advanced/metastatic, intolerable to standard therapy, resistant to effective standard therapy, or for which no standard therapy is available. 3. Availability of a fresh or recent tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy; the sample must have been obtained within 12 months prior to study enrollment. When only bone disease is present, an archival tumor tissue sample obtained within 5 years prior to study enrollment may be accepted for non-prostate cancer patients and a fresh bone biopsy may be accepted for prostate cancer patients only.
Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 or ≥ 1.5 x 109/L
Platelets ≥ 100,000/mm3 or ≥ 100 x 109/L
Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L). 8. Adequate renal function defined by an estimated creatinine clearance (CRCL) ≥ 60 mL/min OR normal creatinine as assessed by 24h urine assessment (not both) will be required during the dose-escalation phase.
Calculate CRCL according to the Cockcroft-Gault formula as: CRCL = \[(140-age) × weight)\]/(72 x SCR)\] × 0.85 (if female), where CRCL (creatinine clearance) is measured in mL/min, age is expressed in years, weight in kilograms (kg), and SCR (serum creatinine) in mg/dL 24h urine assessment:
24h urine assessment will be performed to assess whether creatinine is within normal limits
In the event that 24h urine is used, then CRCL does not require to be calculated NOTE: Patients with moderate renal impairment (30 - 59 mL/min) will be considered during the dose expansion phase. A reduced starting dose for talazoparib will be considered in these patients. If the dose for dose expansion is 1 mg once daily, the dose will be reduced to 0.75 mg once daily. If the expanded dose is 0.75 mg once daily, the dose will be reduced to 0.5 mg once daily. 9. Adequate liver function including:
Total serum bilirubin ≤ 1.5 x the upper limit of normal range (ULN)
Aspartate and Alanine aminotransferase (AST and ALT) ≤ 5 x ULN. 10. Female participants of childbearing potential must have negative serum pregnancy or urine pregnancy test at screening. Female participants of non-childbearing potential must meet at least one of the following criteria:
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state
Have undergone a documented hysterectomy and/or bilateral oophorectomy
Have medically confirmed ovarian failure All other female participants are considered to be of childbearing potential. 11. Evidence of a personally signed and dated informed consent document, within 28 days prior to enrollment, indicating that the participant has been informed of all pertinent aspects of the study. 12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 13. Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.
Exclusion
Myocardial infarction or symptomatic cardiac ischemia within 6 months before screening;
Congestive heart failure New York Heart Association class III or IV;
History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening;
History of Mobitz II second degree or third degree heart block unless a permanent pacemaker is in place;
Hypotension as indicated by systolic blood pressure \<86 mm Hg at screening;
Bradycardia as indicated by a heart rate of \<45 beats per minute on the screening electrocardiogram;
For part B participants only: Uncontrolled hypertension as indicated by systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg despite optimal treatment. Participants can only be on one antihypertensive and stable doses of antihypertensives at discretion of PI. 11. Current use of potent P-gp inhibitors within 7 days prior to enrollment: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin, glecaprevir/pibrentasvir, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, sofosbuvir/velpatasvir/voxilaprevir, telaprevir, tipranavir, valspodar, and verapamil.
Established use of oral, inserted, or injected or implanted hormonal methods of contraception are allowed provided the participant remains on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness.
Correctly placed copper containing intrauterine device (IUD).
Male condom or female condom used with spermicide (i.e. foam, gel, film, cream or suppository).
Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate.
Bilateral tubal ligation or bilateral oophorectomy.
What this trial measures
- Incidence of adverse eventsUp to 30 days after the last investigational product administration
Incidence and severity of adverse events and serious adverse events in patients being treated with the combination of talazoparib with palbociclib (Arm A), axitinib (Arm B), and crizotinib (Arm C). Severity of adverse events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Tabulations will be produced for safety parameters.
- Incidence of dose limiting toxicitiesUp to 30 days after the last investigational product administration
Incidence of dose limiting toxicities of the combination of talazoparib with palbociclib (Arm A), axitinib (Arm B), and crizotinib (Arm C) will be assessed. Severity of AEs will be graded according to the NCI CTCAE version 5.0.