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NCT07036133 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
A Phase 1 study of Advanced Solid Tumors and Hematologic Malignancies, sponsored by Acrotech Biopharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 4
- Study locations
NCT07036133 is a Phase 1 study of Advanced Solid Tumors and Hematologic Malignancies that is actively recruiting participants, run by Acrotech Biopharma. The registered enrollment target is 24 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT07036133, a Phase 1 study of Advanced Solid Tumors and Hematologic Malignancies, is actively recruiting participants, sponsored by Acrotech Biopharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 4
- Study locations
Study Summary
This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment. Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.
Conditions Studied
Interventions
- DRUG Pralatrexate Injection
Study Locations (4)
California
- TOI Clinical Research - Cerritos
Illinois
- Northwestern University - Feinberg School of Medicine - Chicago
Michigan
- Karmanos Cancer Institute - Detroit
Ohio
- Gabrail Cancer Center - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-12-28 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07036133
The ClinicalTrials.gov registry entry for NCT07036133 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (88% lower). The listed sponsor is Acrotech Biopharma, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Pralatrexate Injection is the first listed.
NCT07036133 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT07036133 about?
NCT07036133 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment". This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of eve...
What is the current status of trial NCT07036133?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-12-28. Estimated completion is 2027-09.
What conditions does trial NCT07036133 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Hematologic Malignancies.
What interventions are being tested in trial NCT07036133?
The interventions under investigation include: Pralatrexate Injection (DRUG).
Who is sponsoring clinical trial NCT07036133?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07036133 being conducted?
This trial has 4 study locations across California, Illinois, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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