NCT02551185

ACY 241 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

A Phase 1b Study of the Safety, Pharmacokinetics, and Preliminary Antitumor Activity of ACY 241 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, multicenter, single arm, open label, dose escalation study to determine the MTD and evaluate the safety and preliminary antitumor activity of orally (PO) administered ACY 241 in combination with intravenously (IV) administered paclitaxel in eligible patients with advanced solid tumors.

Detailed description

Patients will receive ACY 241 with dose escalation according to a 3 + 3 design in combination with paclitaxel at the dose and schedule used in clinical practice for the patient population treated in this protocol. Patients will undergo screening assessments for protocol eligibility within 28 days of study start (Cycle 1 Day 1). Patients will receive ACY 241 by oral administration once daily (QD) or, if supported by PK and safety data, twice daily on 21 consecutive days of a 28 day treatment cycle. Paclitaxel will be administered to patients at 80 mg/m2 IV over 1 hour on Days 1, 8, and 15 of the 28 day treatment cycle. Patients who experience a DLT or other unacceptable toxicity in Cycle 1 will be removed from study treatment. Patients will receive study treatment until documented progressive disease (PD) or unacceptable toxicity. Each cohort will consist of at least 3 patients. Patients who withdraw consent in Cycle 1 will be replaced. An assessment of safety will be made by the Safety Review Committee (SRC) before dose escalation. The SRC will be composed of the Study Investigators, the Sponsor's Medical Monitor and Clinical Project Lead, and the Contract Research Organization's Safety Monitor, Project Manager, and Biometrician. Ad hoc members may be invited by the Sponsor as needed.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ACY-241

Timeline

• Start date: 2015-12-22
• Primary completion: 2019-09-30
• Completion: 2019-10-04
• First posted: 2015-09-16
• Last updated: 2020-02-26

Locations

6 sites across 1 country: United States