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NCT04693468 · ClinicalTrials.gov registry record · Phase 1
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
- 1
- Study location
NCT04693468: Recruiting Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04693468 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 111 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04693468, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Axitinib
- DRUG Crizotinib
- DRUG Palbociclib Isethionate
- DRUG Talazoparib Tosylate
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04693468 shows while recruiting
NCT04693468 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (37% lower).
The record links to 3 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Axitinib is the first listed.
NCT04693468 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04693468 about?
NCT04693468 is a clinical study titled "Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial". 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 ...
What is the current status of trial NCT04693468?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2020-12-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04693468 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm.
What interventions are being tested in trial NCT04693468?
The interventions under investigation include: Axitinib (DRUG), Crizotinib (DRUG), Palbociclib Isethionate (DRUG), Talazoparib Tosylate (DRUG).
Who is sponsoring clinical trial NCT04693468?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04693468 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04693468's enrollment target sits among peer trials
111 20th of 108 higher than 89 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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