Trial · NCT02032810
Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma
NCT02032810, Phase 1, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma. Trials, record NCT02032810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02032810
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma
- NCT number
- NCT02032810
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 17 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Melanoma, Skin Cancer
- Interventions
- Panobinostat, Ipilimumab
- First posted
- 2014-01-10
- Last updated
- 2023-01-20
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | Up to 36 months | MTD and recommended Phase 2 dose (RP2D) of panobinostat (PAN), administered in combination with ipilimumab (IPI) in participants with unresectable Stage III or Stage IV melanoma. The goal is to enroll up to 36 patients for determination of the MTD, but will be successfully concluded earlier if 12 patients are accrued at the dose determined to be the MTD, with 3 dose limiting toxicities (DLTs). All participants who receive study any drug therapy will be evaluated for safety. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests. Triplicate 12-lead electrocardiograms (ECGs) will be collected prior to dosing on Day 1 of induction cycle 1. MTD of PAN in milligrams (mg), with IPI at 3 mg/kg. |
| Secondary | Immune Related Overall Response Rate (ORR) | Up to 36 months | Tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Criteria (irRC). RECIST: Best overall response from start of treatment until disease progression/recurrence. Immune-related Complete Response (irCR): Complete disappearance of all tumor lesions for at least 4 weeks from date of documentation of irCR. Immune-related Partial Response (irPR): Sum of the products of the 2 largest perpendicular diameters of all index lesions, measured and captured as the Sum of Product of Diameters (SPD) baseline. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Immune-related Progressive Disease (irPD): At least a 25% increase in the SPD of all index lesions and new measurable lesions (irSPD) over the nadir SPD calculated for the index lesions. |
| Secondary | Progression Free Survival (PFS) | Up to 6 months | Progression Free Survival (PFS): is defined for each participant as the time from first dosing to the first observation of disease progression or death due to any cause. If a subject has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. PFS will be calculated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. |
| Secondary | Overall Survival (OS) | 36 months | Overall survival: The time from randomization until death from any cause. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) | Up to 36 months | All participants | mg | NUMBER |
| SECONDARY | Immune Related Overall Response Rate (ORR) | Up to 36 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) | Up to 6 months | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 36 months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) | Dose Escalation of Panobinostat, Plus Ipilimumab | 5 | mg | ||
| Immune Related Overall Response Rate (ORR) | Panobinostat 5 mg | Partial Response | 1 | Participants | |
| Immune Related Overall Response Rate (ORR) | Panobinostat 10 mg | Partial Response | 1 | Participants | |
| Immune Related Overall Response Rate (ORR) | Panobinostat 5 mg | Complete Response | 0 | Participants | |
| Immune Related Overall Response Rate (ORR) | Panobinostat 10 mg | Complete Response | 0 | Participants | |
| Immune Related Overall Response Rate (ORR) | Panobinostat 5 mg | Stable Disease | 3 | Participants | |
| Immune Related Overall Response Rate (ORR) | Panobinostat 10 mg | Stable Disease | 3 | Participants | |
| Progression Free Survival (PFS) | Panobinostat 5 mg | 4.19 | 95% Confidence Interval 1.68 to NA | Months | |
| Progression Free Survival (PFS) | Panobinostat 10 mg | 1.81 | 95% Confidence Interval 1.45 to NA | Months | |
| Overall Survival (OS) | Panobinostat 5 mg | 25.91 | 95% Confidence Interval 16.17 to NA | Months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panobinostat 5 mg | 6 | |
| Overall Study | STARTED | Panobinostat 10 mg | 11 | |
| Overall Study | COMPLETED | Panobinostat 5 mg | 6 | |
| Overall Study | COMPLETED | Panobinostat 10 mg | 11 | |
| Overall Study | NOT COMPLETED | Panobinostat 5 mg | 0 | |
| Overall Study | NOT COMPLETED | Panobinostat 10 mg | 0 |
Source ClinicalTrials.gov
Adverse events244
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Panobinostat 5 mg | 5 | 6 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Panobinostat 10 mg | 9 | 11 | 33 |
| other | Nausea | Gastrointestinal disorders | Panobinostat 5 mg | 5 | 6 | 8 |
| other | Nausea | Gastrointestinal disorders | Panobinostat 10 mg | 8 | 11 | 14 |
| other | Vomiting | Gastrointestinal disorders | Panobinostat 5 mg | 4 | 6 | 6 |
| other | Vomiting | Gastrointestinal disorders | Panobinostat 10 mg | 5 | 11 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Panobinostat 5 mg | 4 | 6 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Panobinostat 10 mg | 3 | 11 | 6 |
| other | Constipation | Gastrointestinal disorders | Panobinostat 5 mg | 2 | 6 | 2 |
| other | Constipation | Gastrointestinal disorders | Panobinostat 10 mg | 4 | 11 | 4 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panobinostat 5 mg | 1 | 6 |
| Total, all-cause mortality | Panobinostat 10 mg | 0 | 11 |
| Total, other adverse events | Panobinostat 5 mg | 6 | 6 |
| Total, other adverse events | Panobinostat 10 mg | 11 | 11 |
| Total, serious adverse events | Panobinostat 5 mg | 4 | 6 |
| Total, serious adverse events | Panobinostat 10 mg | 7 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Panobinostat 5 mg vs Panobinostat 10 mg: deaths from any cause | Trial comparisons |
| Panobinostat 5 mg vs Panobinostat 10 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02032810
GET https://conductscience.org/api/trials/v1/NCT02032810/events?page=2