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NCT01697293 · ClinicalTrials.gov registry record · Phase 1

PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer

A Phase 1 study, sponsored by Prescient Therapeutics.

Terminated
Registry status
Phase 1
Development phase
34
Enrollment target

NCT01697293: Clinical Trial Phase 1 study, sponsored by Prescient Therapeutics.

NCT01697293 is a Phase 1 study that was terminated before completion, run by Prescient Therapeutics. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01697293, a Phase 1 study, was terminated before completion, sponsored by Prescient Therapeutics.

TERMINATED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

This phase I/II trial studies the side effects and the best dose of triciribine phosphate when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving triciribine phosphate with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide may be a better treatment for breast cancer.

Primary Outcome

The estimated pCR along with exact confidence interval will be presented.

Interventions

  • DRUG Cyclophosphamide
  • OTHER Laboratory Biomarker Analysis
  • DRUG Paclitaxel
  • DRUG Doxorubicin Hydrochloride
  • PROCEDURE Therapeutic Conventional Surgery

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2012-01
Est. Completion 2020-06
Phase Phase 1
Prescient Therapeutics

6 total trials

Why NCT01697293 stopped before completion

NCT01697293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01697293 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01697293 about?

NCT01697293 is a clinical study titled "PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer". This phase I/II trial studies the side effects and the best dose of triciribine phosphate when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine phosphate may stop the growth...

What is the current status of trial NCT01697293?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-01. Estimated completion is 2020-06.

What interventions are being tested in trial NCT01697293?

The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Doxorubicin Hydrochloride (DRUG), Therapeutic Conventional Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01697293?

This trial is sponsored by Prescient Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01697293's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01697293, the US trial registry maintained by the National Library of Medicine. NCT01697293 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.