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NCT00978523 · ClinicalTrials.gov registry record · Phase 1

Study of AR-12 (2-Amino-N-[4-[5-(2 Phenanthrenyl)-3-(Trifluoromethyl)-1H-pyrazol-1-yl] Phenyl]-Acetamide) in Adult Patients With Advanced or Recurrent Solid Tumors or Lymphoma

A Phase 1 study of Lymphoma and Solid Tumors, sponsored by Arno Therapeutics.

Completed
Registry status
Phase 1
Development phase
35
Enrollment target
3
Study locations

NCT00978523 is a Phase 1 study of Lymphoma and Solid Tumors that has completed, run by Arno Therapeutics. The registered enrollment target is 35 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT00978523, a Phase 1 study of Lymphoma and Solid Tumors, has completed, sponsored by Arno Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
35 participants
Enrollment target
3
Study locations

Study Summary

The primary objective of this study in adults with advanced or recurrent solid tumors or lymphoma is to evaluate the safety and tolerability of AR-12 by describing dose-limiting toxicities (DLTs), and thereby establishing the maximum tolerated dose (MTD) or, in the absence of reaching an MTD, a recommended dose (RD) for additional study of oral AR-12 administered daily in cycles of 28 days (28 consecutive days of once daily treatment with at least a 7-day break between the first and second treatment cycles and recovery of toxicity to grade 1 or less, with no planned off-treatment days between subsequent cycles).

Conditions Studied

Interventions

  • DRUG AR-12: (2-Amino-N-[4-[5-(2 phenanthrenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] phenyl]-acetamide)

Study Locations (3)

Arizona

  • TGen Clinical Research Services at Scottsdale Healthcare - Scottsdale

Ohio

  • The Ohio State University - Comprehensive Cancer Center - Columbus

Surrey

  • Royal Marsden Hospital - Sutton

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2009-08
Est. Completion 2013-11
Phase Phase 1

Sponsor

Arno Therapeutics

2 total trials

What the Registry Record Tells You About NCT00978523

The ClinicalTrials.gov registry entry for NCT00978523 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (93% lower). The listed sponsor is Arno Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which AR-12: (2-Amino-N-[4-[5-(2 phenanthrenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] phenyl]-acetamide) is the first listed.

NCT00978523 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Ohio, Surrey.

Frequently Asked Questions

What is clinical trial NCT00978523 about?

NCT00978523 is a clinical study titled "Study of AR-12 (2-Amino-N-[4-[5-(2 Phenanthrenyl)-3-(Trifluoromethyl)-1H-pyrazol-1-yl] Phenyl]-Acetamide) in Adult Patients With Advanced or Recurrent Solid Tumors or Lymphoma". The primary objective of this study in adults with advanced or recurrent solid tumors or lymphoma is to evaluate the safety and tolerability of AR-12 by describing dose-limiting toxicities (DLTs), and thereby establishing the maximum tolerated dose (MTD) or, in the absence of reaching an MTD, a reco...

What is the current status of trial NCT00978523?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2009-08. Estimated completion is 2013-11.

What conditions does trial NCT00978523 study?

This clinical trial studies the following conditions: Lymphoma, Solid Tumors.

What interventions are being tested in trial NCT00978523?

The interventions under investigation include: AR-12: (2-Amino-N-[4-[5-(2 phenanthrenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] phenyl]-acetamide) (DRUG).

Who is sponsoring clinical trial NCT00978523?

This trial is sponsored by Arno Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00978523 being conducted?

This trial has 3 study locations across Arizona, Ohio, Surrey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.