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Checkpoint Inhibitor

Panobinostat for Melanoma

Phase 1

Waitlist Available

Led By Nikhil Khushalani, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

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 36 months

Awards & highlights

Study Summary

This trial is testing if it's safe to give the drugs panobinostat and ipilimumab together, and to see what side effects happen with different doses of panobinostat.

Eligible Conditions

Melanoma
Skin Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose (MTD)

Secondary outcome measures

Immune Related Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Side effects data

From 2012 Phase 3 trial • 41 Patients • NCT01034163

88%

Diarrhoea

58%

Nausea

46%

Vomiting

35%

Fatigue

27%

Neutropenia

27%

Thrombocytopenia

27%

Oropharyngeal pain

23%

Headache

19%

Upper respiratory tract infection

19%

Nasopharyngitis

15%

Sinusitis

15%

Influenza like illness

15%

Pyrexia

15%

Decreased appetite

12%

Leukopenia

12%

Muscle spasms

12%

Depression

12%

Arthralgia

12%

Cough

12%

Dysgeusia

12%

Gastrooesophageal reflux disease

12%

Asthenia

Urinary tract infection

Mucosal dryness

Herpes virus infection

Back pain

Polyneuropathy

Paranasal sinus hypersecretion

Abdominal pain upper

Constipation

Platelet count decreased

Sinusitis bacterial

Cellulitis

Gastroenteritis salmonella

Insomnia

Non-cardiac chest pain

Hypophosphataemia

Pruritus

Abdominal pain

Chills

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Panobinostat (PAN)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment2 Interventions

Dose Escalation of Panobinostat + Ipilimumab. Participants will be assigned to receive a certain dose of panobinostat (5, 10, 15, or 20 mg) along with a dose of ipilimumab of 3 mg per kg (mg/kg) of body weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panobinostat

2011

Completed Phase 3

~1560

Ipilimumab

2014

Completed Phase 3

~2620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,721,018 Total Patients Enrolled

19 Trials studying Melanoma

3,855 Patients Enrolled for Melanoma

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,475 Total Patients Enrolled

43 Trials studying Melanoma

3,201 Patients Enrolled for Melanoma

Nikhil Khushalani, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

2 Previous Clinical Trials

87 Total Patients Enrolled

2 Trials studying Melanoma

87 Patients Enrolled for Melanoma

Frequently Asked Questions

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

What therapeutic uses has Panobinostat been utilized to address?

"Panobinostat is generally prescribed for the management of cutaneous melanoma, but it can also potentially be beneficial to patients with complete resection, liver carcinoma, and metastatic lesions."

Answered by AI

How many participants are being recruited for this research project?

"This clinical trial has since concluded; the posting was initially made on July 1st 2014, and the last update was September 27th 2022. However, there are still 817 trials recruiting patients with melanoma and 330 more actively looking for participants to test Panobinostat."

Answered by AI

In what other research endeavors has Panobinostat been utilized?

"Presently, there are 330 clinical trials that involve panobinostat with 38 of those being in phase 3. Of those, several take place in Pittsburgh, PA and the rest span 20 569 different locations worldwide."

Answered by AI

Are there any remaining opportunities to enroll in this clinical trial?

"According to clinicaltrials.gov, this particular study has ceased participation recruitment and was last modified on September 27th 2022. Unfortunately it is not currently accepting participants; however there are 1147 other trials open for enrolment at the present moment."

Answered by AI

Has the FDA sanctioned Panobinostat for use?

"The relatively limited amount of data regarding Panobinostat's safety and efficacy leads to the conclusion that it is safe enough for a Phase 1 trial, thus receiving an estimation rating of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma

2014. "Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02032810.