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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: Recruiting Phase 1 study of Advanced Solid Tumors and Hematologic Malignancies, sponsored by Acrotech Biopharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood will be collected to evaluate the pharmacokinetic (PK) profile of pralatrexate (plasma concentration levels) when administered to patients with various degrees of hepatic impairment.
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 |
What NCT07036133 shows while recruiting
NCT07036133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
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 NCT07036133's enrollment target sits among peer trials
24 122nd of 144 higher than 21 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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