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NCT01118624 · ClinicalTrials.gov registry record · Phase 2

Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer

A Phase 2 study, sponsored by Acrotech Biopharma.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT01118624: Completed Phase 2 study, sponsored by Acrotech Biopharma.

NCT01118624 is a Phase 2 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01118624, a Phase 2 study, has completed, sponsored by Acrotech Biopharma.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.

Primary Outcome

Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.

Interventions

  • DIETARY_SUPPLEMENT Vitamin B12
  • DRUG Pralatrexate Injection
  • DIETARY_SUPPLEMENT Folic Acid

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2010-03
Est. Completion 2012-07
Phase Phase 2
Acrotech Biopharma

24 total trials

What the finished NCT01118624 record still lists

NCT01118624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which Vitamin B12 is the first listed.

NCT01118624 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01118624 about?

NCT01118624 is a clinical study titled "Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer". The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supple...

What is the current status of trial NCT01118624?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2010-03. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01118624?

The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate Injection (DRUG), Folic Acid (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01118624?

This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01118624's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01118624, the US trial registry maintained by the National Library of Medicine. NCT01118624 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.