NCT00978523

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 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, for Which No Standard Therapy Is Available

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Arno Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a single-agent, open-label, Phase 1, dose-escalation study in adult patients with advanced or recurrent solid tumors or lymphoma. Patients will receive orally administered AR-12 once daily for 28 consecutive days. The first dosing cycle will be followed by at least a 7 day off-treatment period; however, no off-treatment period will be scheduled between subsequent treatment cycles. If daily dosing is not tolerated by the study population, alternative dosing schedules may be pursued (eg, 21 consecutive days of dosing followed by 7 days off treatment), as indicated by the safety, pharmacokinetic, and pharmacodynamic data; all changes to the protocol-specified dosing schedule must be agreed upon by the investigators and the medical monitor. If individual patients respond to AR-12 treatment with an objective response or stable disease according to RECIST criteria and meet pre-specified retreatment criteria, they may continue to receive cycles of AR-12 in the absence of untoward or serious toxicity; however, no patient is permitted to start a subsequent cycle after each bi-monthly disease evaluation until it is confirmed that disease progression has not occurred.

Conditions

• Solid Tumors
• Lymphoma

Interventions

Type	Name	Description
DRUG	AR-12: (2-Amino-N-[4-[5-(2 phenanthrenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] phenyl]-acetamide)	Oral, dose-escalation

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-09-17
• Last updated: 2014-01-29

Locations

3 sites across 2 countries: United States, United Kingdom