Actively Recruiting
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
Led by M.D. Anderson Cancer Center · Updated on 2026-03-13
111
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Palbociclib, axitinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib in combination with palbociclib, axitinib, or crizotinib may help control locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a pathogenic or likely pathogenic germline or somatic gene defect in DNA damage response genes or related genes as determined by local assessment
- Have a histological or cytological diagnosis of advanced or metastatic solid tumor that is intolerable to, resistant to, or without effective standard therapy
- Have a fresh or recent tumor tissue sample obtained within 12 months prior to enrollment (bone disease exceptions apply)
- Have measurable disease at enrollment as defined by RECIST v1.1 or evaluable bone metastatic disease for prostate cancer
- Be 18 years of age or older
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate bone marrow function without recent growth factor or transfusion support
- Have adequate renal function with creatinine clearance ≥ 60 mL/min or normal creatinine by 24-hour urine during dose-escalation phase
- Have adequate liver function with serum bilirubin ≤ 1.5 times upper limit normal and AST/ALT ≤ 5 times upper limit normal
- Female participants of childbearing potential must have a negative pregnancy test at screening; non-childbearing females must meet specific menopause or surgical criteria
- Provide signed informed consent within 28 days prior to enrollment
- Be willing and able to comply with study visits, treatment plan, and procedures
- Be able to swallow study drugs and have no known intolerance to study drugs or excipients
You will not qualify if you...
- Received anti-cancer therapy or radiation therapy within 2 weeks prior to enrollment (except some palliative radiotherapy)
- Had major surgery within 4 weeks prior to enrollment
- Known hypersensitivity to talazoparib or assigned combination drug (palbociclib, axitinib, or crizotinib)
- Diagnosis of myelodysplastic syndrome (MDS)
- Have symptomatic brain metastases requiring steroids
- Persisting toxicity from prior therapy greater than grade 1 (with some exceptions)
- Active infection requiring systemic therapy
- Uncontrolled HIV or AIDS; controlled HIV allowed
- Uncontrolled hepatitis B or C infection; controlled infection allowed
- Clinically significant cardiovascular disease including recent myocardial infarction, severe heart failure, serious arrhythmias, heart block without pacemaker, low blood pressure, or bradycardia
- For participants in Arm B, uncontrolled hypertension despite treatment
- Use of potent P-gp inhibitors within 7 days prior to enrollment or recent use of strong CYP3A4 inhibitors or inducers
- Inability to swallow capsules or malabsorption conditions
- Unstable dosage of bisphosphonate or denosumab within 2 weeks prior to enrollment
- Other medical or psychiatric conditions that increase risk or interfere with study participation
- Diagnosis of other malignancy within 2 years prior to enrollment except certain treated low-risk cancers
- Pregnant or breastfeeding females, fertile males, or females of childbearing potential unwilling or unable to use two methods of contraception during and after study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Timothy A. Yap
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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