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Trial record 100 of 1215 for:    "Hodgkin lymphoma"

A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) (PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01034163
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hodgkin's Lymphoma
Interventions Drug: Panobinostat
Drug: Placebo
Enrollment 41
Recruitment Details Participants were randomized in a 2:1 ratio to the PAN and placebo groups, respectively.
Pre-assignment Details  
Arm/Group Title Panobinostat (PAN) Placebo
Hide Arm/Group Description Participants received 45 mg orally 3 times a week (TIW), every other week (QOW). Participants received matching placebo to PAN TIW, QOW.
Period Title: Overall Study
Started 27 14
Untreated (Not in Safety Set) 1 2
Safety Set 26 12
In Open Label Phase After Unblinding 5 0
Completed 0 0
Not Completed 27 14
Reason Not Completed
Treatment completed as per protocol             8             7
Withdrawal by Subject             8             2
Protocol deviation             1             0
Disease progression             3             4
Adverse Event             6             0
Administrative problems             0             1
Abnormal laboratory value             1             0
Arm/Group Title Panobinostat (PAN) Placebo Total
Hide Arm/Group Description Participants received 45 mg orally 3 times a week (TIW), every other week (QOW). Participants received matching placebo to PAN TIW, QOW. Total of all reporting groups
Overall Number of Baseline Participants 27 14 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 14 participants 41 participants
34.0  (10.72) 30.6  (10.56) 32.9  (10.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 14 participants 41 participants
Female
8
  29.6%
7
  50.0%
15
  36.6%
Male
19
  70.4%
7
  50.0%
26
  63.4%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Safety monitoring was conducted throughout the study.
Time Frame 23 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included randomized participants who received at least one dose of study treatment.
Arm/Group Title Panobinostat (PAN) Placebo
Hide Arm/Group Description:
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
Participants received matching placebo to PAN TIW, QOW.
Overall Number of Participants Analyzed 26 12
Measure Type: Number
Unit of Measure: Participants
26 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Panobinostat (PAN) Placebo
Hide Arm/Group Description Participants received 45 mg orally 3 times a week (TIW), every other week (QOW). Participants received matching placebo to PAN TIW, QOW.
All-Cause Mortality
Panobinostat (PAN) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panobinostat (PAN) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/26 (7.69%)   1/12 (8.33%) 
General disorders     
Pyrexia  1  1/26 (3.85%)  0/12 (0.00%) 
Infections and infestations     
Cellulitis  1  1/26 (3.85%)  0/12 (0.00%) 
Gastroenteritis salmonella  1  1/26 (3.85%)  0/12 (0.00%) 
Herpes zoster  1  0/26 (0.00%)  1/12 (8.33%) 
Sinusitis bacterial  1  1/26 (3.85%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panobinostat (PAN) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   11/12 (91.67%) 
Blood and lymphatic system disorders     
Anaemia  1  0/26 (0.00%)  1/12 (8.33%) 
Leukopenia  1  3/26 (11.54%)  2/12 (16.67%) 
Neutropenia  1  7/26 (26.92%)  4/12 (33.33%) 
Thrombocytopenia  1  7/26 (26.92%)  1/12 (8.33%) 
Gastrointestinal disorders     
Abdominal pain  1  1/26 (3.85%)  2/12 (16.67%) 
Abdominal pain upper  1  2/26 (7.69%)  0/12 (0.00%) 
Constipation  1  2/26 (7.69%)  0/12 (0.00%) 
Diarrhoea  1  23/26 (88.46%)  3/12 (25.00%) 
Gastrooesophageal reflux disease  1  3/26 (11.54%)  0/12 (0.00%) 
Nausea  1  15/26 (57.69%)  1/12 (8.33%) 
Toothache  1  0/26 (0.00%)  1/12 (8.33%) 
Vomiting  1  12/26 (46.15%)  3/12 (25.00%) 
General disorders     
Asthenia  1  3/26 (11.54%)  1/12 (8.33%) 
Chills  1  1/26 (3.85%)  1/12 (8.33%) 
Fatigue  1  9/26 (34.62%)  3/12 (25.00%) 
Influenza like illness  1  4/26 (15.38%)  0/12 (0.00%) 
Mucosal dryness  1  2/26 (7.69%)  0/12 (0.00%) 
Non-cardiac chest pain  1  1/26 (3.85%)  1/12 (8.33%) 
Pyrexia  1  4/26 (15.38%)  1/12 (8.33%) 
Swelling  1  0/26 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Herpes ophthalmic  1  0/26 (0.00%)  1/12 (8.33%) 
Herpes virus infection  1  2/26 (7.69%)  1/12 (8.33%) 
Herpes zoster  1  0/26 (0.00%)  2/12 (16.67%) 
Influenza  1  0/26 (0.00%)  1/12 (8.33%) 
Nasopharyngitis  1  5/26 (19.23%)  0/12 (0.00%) 
Oral infection  1  0/26 (0.00%)  1/12 (8.33%) 
Pharyngitis  1  0/26 (0.00%)  1/12 (8.33%) 
Sinusitis  1  4/26 (15.38%)  1/12 (8.33%) 
Upper respiratory tract infection  1  5/26 (19.23%)  1/12 (8.33%) 
Urinary tract infection  1  2/26 (7.69%)  0/12 (0.00%) 
Investigations     
Blood triglycerides increased  1  0/26 (0.00%)  1/12 (8.33%) 
Platelet count decreased  1  2/26 (7.69%)  0/12 (0.00%) 
Weight decreased  1  0/26 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders     
Decreased appetite  1  4/26 (15.38%)  2/12 (16.67%) 
Hypercholesterolaemia  1  0/26 (0.00%)  1/12 (8.33%) 
Hypophosphataemia  1  1/26 (3.85%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/26 (11.54%)  0/12 (0.00%) 
Back pain  1  2/26 (7.69%)  1/12 (8.33%) 
Muscle spasms  1  3/26 (11.54%)  1/12 (8.33%) 
Pain in extremity  1  0/26 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Dysaesthesia  1  0/26 (0.00%)  1/12 (8.33%) 
Dysgeusia  1  3/26 (11.54%)  0/12 (0.00%) 
Headache  1  6/26 (23.08%)  0/12 (0.00%) 
Polyneuropathy  1  2/26 (7.69%)  0/12 (0.00%) 
Tremor  1  0/26 (0.00%)  1/12 (8.33%) 
Psychiatric disorders     
Depression  1  3/26 (11.54%)  0/12 (0.00%) 
Insomnia  1  1/26 (3.85%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/26 (11.54%)  1/12 (8.33%) 
Dyspnoea exertional  1  0/26 (0.00%)  1/12 (8.33%) 
Oropharyngeal pain  1  7/26 (26.92%)  0/12 (0.00%) 
Paranasal sinus hypersecretion  1  2/26 (7.69%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/26 (0.00%)  1/12 (8.33%) 
Dermatitis acneiform  1  0/26 (0.00%)  1/12 (8.33%) 
Pruritus  1  1/26 (3.85%)  1/12 (8.33%) 
Rash  1  0/26 (0.00%)  1/12 (8.33%) 
Vascular disorders     
Flushing  1  0/26 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01034163     History of Changes
Other Study ID Numbers: CLBH589E2301
2009-014846-26
First Submitted: December 15, 2009
First Posted: December 17, 2009
Results First Submitted: March 1, 2016
Results First Posted: July 7, 2016
Last Update Posted: July 7, 2016