Phase 1: testing Axitinib for Advanced Malignant Solid Neoplasm
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.
Official registry: https://clinicaltrials.gov/study/NCT04693468 · M.D. Anderson Cancer Center · enrollment listed as 111
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Axitinib, Crizotinib, or Palbociclib Isethionate. The registry lists allocation as randomized. 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).
They plan to enroll about 111 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Modular Phase 1B Hypothesis-Testing, Biomarker-Driven, Talazoparib Combination Trial (TalaCom)
Interventions: Axitinib, Crizotinib, Palbociclib Isethionate, Talazoparib Tosylate
Primary outcome (registry wording): Incidence of adverse events
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification in at least one of the following:
- 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):
- 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
Who the registry excludes
- Major surgery within 4 weeks prior to study enrollment
- Participants with known hypersensitivity to either talazoparib or the additional study drug to be received per treatment arm: palbociclib (Arm A), axitinib (Arm B), crizotinib (Arm C)
- Diagnosis of myelodysplastic syndrome (MDS)
- Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade \> 1). However, alopecia and sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 side effects not constituting a safety risk, based on the investigators judgement, are acceptable
- Active infection requiring systemic therapy. Minor infections, e.g. periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed
- Participants with known uncontrolled HIV virus or Acquired immunodeficiency syndrome. Note: Patients with history of controlled HIV virus will be considered eligible for this trial
- Participants with uncontrolled Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Note: Participants with controlled hepatitis B or hepatitis C will be considered eligible for this trial
Public study contact (from the registry)
Timothy A. Yap
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- M D Anderson Cancer Center — Houston, Texas (recruiting)
FAQ about this NCT record
Is NCT04693468 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04693468?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04693468?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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