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NCT01310244 · ClinicalTrials.gov registry record · Phase 1

MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC

A Phase 1 study, sponsored by Acrotech Biopharma.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target

NCT01310244: Completed Phase 1 study, sponsored by Acrotech Biopharma.

NCT01310244 is a Phase 1 study that has completed, run by Acrotech Biopharma. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01310244, a Phase 1 study, has completed, sponsored by Acrotech Biopharma.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

Study Summary

To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung Cancer (NSCLC).

Primary Outcome

At study entry each eligible patient will be assigned a specific dose level and dose of IV belinostat in mg/m2, to be administered daily on Days 1 to 5 each 21 day cycle, for up to 6 cycles. Dose escalation within each patient is not allowed during this study. At each dose level cohort of up to 6 patients may be evaluated during Cycle 1 of therapy. Multiple dose levels may be evaluated to determine the Maximum Tolerated Dose (MTD) of IV belinostat, in combination with 6 cycles of IV carboplatin

Interventions

  • DRUG Belinostat, Carboplatin, Paclitaxel

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-12
Est. Completion 2015-08
Phase Phase 1
Acrotech Biopharma

24 total trials

What the finished NCT01310244 record still lists

NCT01310244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 1 intervention - of which Belinostat, Carboplatin, Paclitaxel is the first listed.

NCT01310244 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01310244 about?

NCT01310244 is a clinical study titled "MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC". To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung Cancer (NSCLC).

What is the current status of trial NCT01310244?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-12. Estimated completion is 2015-08.

What interventions are being tested in trial NCT01310244?

The interventions under investigation include: Belinostat, Carboplatin, Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT01310244?

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 NCT01310244's enrollment target sits among peer trials

23 1596th of 2000 higher than 400 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 NCT01310244, the US trial registry maintained by the National Library of Medicine. NCT01310244 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.