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Advanced Solid TumorsPhase 1NCT02551185

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

A Phase 1 study testing ACY-241 in people with Advanced Solid Tumors, run by Celgene at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ACY-241
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
6 sitesUnited States
Study dates
22 Dec 2015to 4 Oct 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) before entering the study or those who have not recovered from AEs to ≤ Grade 1 (except for peripheral neuropathy; see Exclusion Criterion 12) due to agents administered more than 4 weeks earlier.
  • Previous therapy with histone deacetylase (HDAC) inhibitor.
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  • 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.
  • Positive human immunodeficiency virus, hepatitis B virus, and hepatitis C virus infection.
  • Hypersensitivity to taxanes (such as Steven Johnson syndrome). Hypersensitivity, such as rash < Grade 3 that is managed, is allowed.
  • Peripheral neuropathy > Grade 2 despite supportive therapy.
  • Patients who received any of the following within the 14 days before initiating study treatment:
  • Major surgery
  • Radiation therapy
  • Systemic therapy (standard or an investigational or biological anticancer agent)
  • Current enrollment in another clinical study involving treatment and/or is receiving an investigational agent for any reason, or use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment.
  • Incidence of gastrointestinal disease that may significantly alter the absorption of ACY 241.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Remove - Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • CTRC at The UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
ACY-241

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACY-241Drug

Study groups in NCT02551185
Study groupRoleWhat they receive
ACY-241 in combination with PaclitaxelExperimentalNot described
Receives: Drug: ACY-241

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities (DLTs)

    Measured: 12 months

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

    Measured: 12 months

  3. Maximum tolerated dose (MTD), if present.

    Measured: 12 months

Secondary outcomes (2)

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

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2015 (estimated)
  2. Study start22 Dec 2015
  3. Primary completion30 Sep 2019
  4. Study completion4 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551185
Sponsor's protocol ID
ACE-ST-201
Status last verified
Feb 2020
First submitted
11 Sep 2015
Last updated
26 Feb 2020
Results posted
No

Publications

  • 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.

    PubMed 35070991

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACY-241 in people with Advanced Solid Tumors, run by Celgene at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLTs) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02551185, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.

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