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NCT05142241 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial

A Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
14
Enrollment target
2
Study locations

NCT05142241: Active Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, sponsored by National Cancer Institute (NCI).

NCT05142241 is a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05142241, a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
14 participants
Enrollment target
2
Study locations

Study Summary

This phase II trial tests whether combination of talazoparib and temozolomide works to shrink tumors in patients with rare cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Talazoparib is an inhibitor of poly adenosine diphosphate-ribose polymerase (PARP), an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It damages the cell's DNA and may kill cancer cells. Giving talazoparib in combination with temozolomide may help shrink advanced rare cancers or stop them from growing.

Primary Outcome

The number of participants with an objective response to treatment, defined as a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Overall Response (OR) = CR + PR with CR indicating the disappearance of all target lesions and PR defined as a 30% or more decrease in the sum of the longest diameter of target lesions.

Conditions Studied

Malignant Solid Neoplasm Hematopoietic and Lymphatic System Neoplasm Paraganglioma Adrenal Gland Pheochromocytoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • DRUG Temozolomide
  • DRUG Talazoparib

Study Locations (2)

Maryland

  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda
  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2022-07-11
Est. Completion 2026-09-29
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT05142241 still lists

NCT05142241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (99% lower).

The record links to 4 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05142241 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT05142241 about?

NCT05142241 is a clinical study titled "Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial". This phase II trial tests whether combination of talazoparib and temozolomide works to shrink tumors in patients with rare cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Talazoparib is an inhibitor of poly adenosine dip...

What is the current status of trial NCT05142241?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2022-07-11. Estimated completion is 2026-09-29.

What conditions does trial NCT05142241 study?

This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm, Paraganglioma, Adrenal Gland Pheochromocytoma.

What interventions are being tested in trial NCT05142241?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Temozolomide (DRUG), Talazoparib (DRUG).

Who is sponsoring clinical trial NCT05142241?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05142241 being conducted?

This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Malignant Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05142241's enrollment target sits among peer trials

14 167th of 176 higher than 10 of 176 other Malignant Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05142241, the US trial registry maintained by the National Library of Medicine. NCT05142241 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.