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

NCT02551185 | Completed Phase 1

• 1 other identifier: ACE-ST-201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicities (DLTs)

  12 months

• Recommended phase 2 dose and schedule of ACY 241 in combination with paclitaxel on a weekly schedule.

  12 months

• Maximum tolerated dose (MTD), if present.

  12 months

Secondary Outcomes (2)

• Safety profile of ACY 241 administered in combination with paclitaxel.

  12 months

• Preliminary antitumor activity of ACY 241 administered in combination with paclitaxel in the patient population.

  12 months

Study Arms (1)

ACY-241 in combination with Paclitaxel

EXPERIMENTAL

Drug: ACY-241

Interventions

ACY-241 DRUG

ACY-241 in combination with Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to understand and voluntarily sign an informed consent form (ICF).
• Must be ≥ 18 years of age at the time of signing the ICF.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• Patients must have a histologically confirmed nonhematological, metastatic or locally advanced, incurable malignancy for which paclitaxel is clinically appropriate. Patients must have received and failed standard treatment for their malignancy; patients for whom no standard treatment is available will also be eligible.
• Evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Life expectancy \> 12 weeks.
• Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
• Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Females of childbearing potential must have a negative pregnancy test. It is not known if the antideacetylase activity of this experimental drug may be harmful to the developing fetus or nursing infant.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from giving informed consent.
• Any serious concurrent medical conditions, laboratory abnormality, or psychiatric illness that might make the patient nonevaluable, put the patient's safety at risk, or prevent the patient from following the study requirements.
• Pregnant or lactating females.
• Patients with uncontrolled brain metastases.
• Previous therapy with histone deacetylase (HDAC) inhibitor.
• Any of the following laboratory abnormalities:
• ANC \< 1,500/µL.
• Platelet count \< 100,000/µL
• Hematologic growth factors are not allowed at Screening or during the first cycle of treatment.
• Hemoglobin \< 9 g/dL (\< 5.5 mmol/L; previous red blood cell \[RBC\] transfusion is permitted).
• Creatinine \> 1.5 × upper limit of normal (ULN).
• AST or ALT \> 2.5 × ULN. For patients with liver metastasis AST or ALT \> 5 × ULN.
• Serum total bilirubin \> 1.5 mg/dL or \> 3 × ULN for patients with hereditary benign hyperbilirubinemia
• Corrected QT interval (QTc) using Fridericia's formula (QTcF) value \> 480 msec at Screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at Screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG).
• Congestive heart failure (New York Heart Association Class III or IV), myocardial infarction within 12 months before starting study treatment, or unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.

Sponsors & Collaborators

• Celgene: lead

Study Sites (6)

Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

Remove - Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

CTRC at The UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Gordon MS, Shapiro GI, Sarantopoulos J, Juric D, Lu B, Zarotiadou A, Connarn JN, Le Bruchec Y, Dumitru CD, Harvey RD. Phase Ib Study of the Histone Deacetylase 6 Inhibitor Citarinostat in Combination With Paclitaxel in Patients With Advanced Solid Tumors. Front Oncol. 2022 Jan 7;11:786120. doi: 10.3389/fonc.2021.786120. eCollection 2021.

  PMID: 35070991 DERIVED

MeSH Terms

Interventions

citarinostat

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 16, 2015
• Study Start: December 22, 2015
• Primary Completion: September 30, 2019
• Study Completion: October 4, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

US (6)