Trial Outcomes & Findings for A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) (NCT NCT01034163)
NCT ID: NCT01034163
Last Updated: 2016-07-07
Results Overview
Safety monitoring was conducted throughout the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
23 months
Results posted on
2016-07-07
Participant Flow
Participants were randomized in a 2:1 ratio to the PAN and placebo groups, respectively.
Participant milestones
| Measure |
Panobinostat (PAN)
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
|
Placebo
Participants received matching placebo to PAN TIW, QOW.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
14
|
|
Overall Study
Untreated (Not in Safety Set)
|
1
|
2
|
|
Overall Study
Safety Set
|
26
|
12
|
|
Overall Study
In Open Label Phase After Unblinding
|
5
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
14
|
Reasons for withdrawal
| Measure |
Panobinostat (PAN)
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
|
Placebo
Participants received matching placebo to PAN TIW, QOW.
|
|---|---|---|
|
Overall Study
Treatment completed as per protocol
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Protocol deviation
|
1
|
0
|
|
Overall Study
Disease progression
|
3
|
4
|
|
Overall Study
Adverse Event
|
6
|
0
|
|
Overall Study
Administrative problems
|
0
|
1
|
|
Overall Study
Abnormal laboratory value
|
1
|
0
|
Baseline Characteristics
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)
Baseline characteristics by cohort
| Measure |
Panobinostat (PAN)
n=27 Participants
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
|
Placebo
n=14 Participants
Participants received matching placebo to PAN TIW, QOW.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 Years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
30.6 Years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
32.9 Years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 23 monthsPopulation: Safety set: The safety set included randomized participants who received at least one dose of study treatment.
Safety monitoring was conducted throughout the study.
Outcome measures
| Measure |
Panobinostat (PAN)
n=26 Participants
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
|
Placebo
n=12 Participants
Participants received matching placebo to PAN TIW, QOW.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
26 Participants
|
11 Participants
|
Adverse Events
Panobinostat (PAN)
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panobinostat (PAN)
n=26 participants at risk
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
|
Placebo
n=12 participants at risk
Participants received matching placebo to PAN TIW, QOW.
|
|---|---|---|
|
General disorders
Pyrexia
|
3.8%
1/26
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26
|
0.00%
0/12
|
|
Infections and infestations
Gastroenteritis salmonella
|
3.8%
1/26
|
0.00%
0/12
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26
|
8.3%
1/12
|
|
Infections and infestations
Sinusitis bacterial
|
3.8%
1/26
|
0.00%
0/12
|
Other adverse events
| Measure |
Panobinostat (PAN)
n=26 participants at risk
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
|
Placebo
n=12 participants at risk
Participants received matching placebo to PAN TIW, QOW.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/26
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.5%
3/26
|
16.7%
2/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.9%
7/26
|
33.3%
4/12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.9%
7/26
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26
|
16.7%
2/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
2/26
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
7.7%
2/26
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
88.5%
23/26
|
25.0%
3/12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.5%
3/26
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
57.7%
15/26
|
8.3%
1/12
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/26
|
8.3%
1/12
|
|
Gastrointestinal disorders
Vomiting
|
46.2%
12/26
|
25.0%
3/12
|
|
General disorders
Asthenia
|
11.5%
3/26
|
8.3%
1/12
|
|
General disorders
Chills
|
3.8%
1/26
|
8.3%
1/12
|
|
General disorders
Fatigue
|
34.6%
9/26
|
25.0%
3/12
|
|
General disorders
Influenza like illness
|
15.4%
4/26
|
0.00%
0/12
|
|
General disorders
Mucosal dryness
|
7.7%
2/26
|
0.00%
0/12
|
|
General disorders
Non-cardiac chest pain
|
3.8%
1/26
|
8.3%
1/12
|
|
General disorders
Pyrexia
|
15.4%
4/26
|
8.3%
1/12
|
|
General disorders
Swelling
|
0.00%
0/26
|
8.3%
1/12
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/26
|
8.3%
1/12
|
|
Infections and infestations
Herpes virus infection
|
7.7%
2/26
|
8.3%
1/12
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26
|
16.7%
2/12
|
|
Infections and infestations
Influenza
|
0.00%
0/26
|
8.3%
1/12
|
|
Infections and infestations
Nasopharyngitis
|
19.2%
5/26
|
0.00%
0/12
|
|
Infections and infestations
Oral infection
|
0.00%
0/26
|
8.3%
1/12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/26
|
8.3%
1/12
|
|
Infections and infestations
Sinusitis
|
15.4%
4/26
|
8.3%
1/12
|
|
Infections and infestations
Upper respiratory tract infection
|
19.2%
5/26
|
8.3%
1/12
|
|
Infections and infestations
Urinary tract infection
|
7.7%
2/26
|
0.00%
0/12
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/26
|
8.3%
1/12
|
|
Investigations
Platelet count decreased
|
7.7%
2/26
|
0.00%
0/12
|
|
Investigations
Weight decreased
|
0.00%
0/26
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
4/26
|
16.7%
2/12
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/26
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.8%
1/26
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.5%
3/26
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.5%
3/26
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26
|
8.3%
1/12
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/26
|
8.3%
1/12
|
|
Nervous system disorders
Dysgeusia
|
11.5%
3/26
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
23.1%
6/26
|
0.00%
0/12
|
|
Nervous system disorders
Polyneuropathy
|
7.7%
2/26
|
0.00%
0/12
|
|
Nervous system disorders
Tremor
|
0.00%
0/26
|
8.3%
1/12
|
|
Psychiatric disorders
Depression
|
11.5%
3/26
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
3/26
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/26
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
26.9%
7/26
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
7.7%
2/26
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/26
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/26
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26
|
8.3%
1/12
|
|
Vascular disorders
Flushing
|
0.00%
0/26
|
8.3%
1/12
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER