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Histone Deacetylase Inhibitor

ACY-241 for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one to two years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it is safe, how well it is tolerated, and what the maximum dose that can be given without severe side effects is.

Who is the study for?

This trial is for adults over 18 with unresectable Non-Small Cell Lung Cancer (NSCLC) who have had one prior therapy and are now facing progression or toxicity. They must be able to perform daily activities with minimal assistance, agree to use birth control, and provide biopsies. Excluded are those with serious medical conditions, brain metastases not stable after treatment, recent chemotherapy, certain blood abnormalities, heart issues, autoimmune diseases needing immunosuppression, or active viral infections.Check my eligibility

What is being tested?

The trial tests the safety and tolerability of a new drug combo: ACY-241 with Nivolumab. It aims to find the highest dose patients can take without severe side effects by gradually increasing amounts until they reach a limit due to toxic reactions.See study design

What are the potential side effects?

Possible side effects include typical reactions from immune therapies like fatigue, skin rash or itching; gastrointestinal symptoms such as nausea or diarrhea; potential changes in liver enzymes indicating liver stress; and possibly lowered blood cell counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one to two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and one to two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

recommended Phase 2 dose (RP2D) of ACY 241 in combination with nivolumab

Secondary outcome measures

Maximum Plasma Concentration [Cmax] of ACY 241 in combination with nivolumab on biomarkers in peripheral blood and tumor tissue

preliminary antitumor activity of ACY 241 in combination with nivolumab

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Chills

Hypertension

Hyperkalaemia

Hyperglycaemia

Dehydration

Blood alkaline phosphatase increased

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Hypercalcaemia

Pericardial effusion malignant

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: ACY-241 in combination with nivolumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ACY-241

2016

Completed Phase 1

~30

Nivolumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,955 Total Patients Enrolled

Ileana Elias, MDStudy DirectorCelgene

3 Previous Clinical Trials

747 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of individuals participating in this experiment?

"At the present moment, this particular medical trial is not seeking new participants. It was first posted on August 25th 2016 and last updated November 3rd 2022. If you are looking for other studies to join, there are currently 2045 trials recruiting patients with carcinoma non-small cell lung cancer and 717 clinical trials accepting volunteers for ACY-241 testing."

Answered by AI

Has the FDA sanctioned ACY-241 for medical usage?

"The team at Power estimated ACY-241's safety rating to be 1 due to the fact that this is a phase 1 trial, meaning there is only sparse data available in regards to both efficacy and safety."

Answered by AI

Has this trial been conducted previously or is it a pioneering endeavor?

"Currently, 2356 cities from 49 countries are hosting 717 active clinical trials for ACY-241. Ono Pharmaceutical Co. Ltd first launched the investigation back in 2012 with 659 participants, successfully completing its phase 1 and 2 of drug approval before 253 other experiments were completed subsequently."

Answered by AI

Is this research endeavor welcoming new participants?

"This research study is no longer seeking new participants. Originally posted on August 25th of 2016, the most recent update to this trial was made November 3rd 2022. For those searching for more trials related to carcinoma, non-small cell lung and ACY-241 there are currently 2045 and 717 studies respectively that are actively enrolling patients."

Answered by AI

In what medical contexts is ACY-241 typically administered?

"ACY-241 is an effective option for the treatment of malignant neoplasms, unresectable melanomas, and squamous cell carcinoma."

Answered by AI

Are there any other experiments conducted with ACY-241 that have yielded noteworthy results?

"Currently, there are 717 studies exploring the effects of ACY-241 with 82 in Phase 3. While most trials take place in Zürich, BE, 40281 sites worldwide are conducting research on this medication."

Answered by AI

Recent research and studies

Frontiers in OncologyJournal

Selective Histone Deacetylase Inhibitor ACY-241 (citarinostat) Plus Nivolumab in Advanced Non-small Cell Lung Cancer: Results from a Phase Ib Study

Awad, Mark M., Yvan Le Bruchec, Brian Lu, Jason Ye, JulieAnn Miller, Patrick H. Lizotte, Megan E. Cavanaugh, Amanda J. Rode, Calin Dan Dumitru, and Alexander Spira. 2021. “Selective Histone Deacetylase Inhibitor ACY-241 (citarinostat) Plus Nivolumab in Advanced Non-small Cell Lung Cancer: Results from a Phase Ib Study”. Frontiers in Oncology. Frontiers Media SA. doi:10.3389/fonc.2021.696512.

Frontiers in OncologyJournal

Selective Histone Deacetylase Inhibitor ACY-241 (citarinostat) Plus Nivolumab in Advanced Non-small Cell Lung Cancer: Results from a Phase Ib Study

clinicaltrials.govStudy

Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer

2016. "Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02635061.

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