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Panobinostat and Everolimus in Treating Patients With Metastatic or Unresectable Renal Cell Cancer That Does Not Respond to Treatment With Sunitinib Malate or Sorafenib Tosylate

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ClinicalTrials.gov Identifier: NCT01582009
Recruitment Status : Terminated (pts off study, PI left institute)
First Posted : April 20, 2012
Results First Posted : May 17, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Novartis
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions Drug: panobinostat
Drug: everolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Other: liquid chromatography
Other: mass spectrometry
Other: enzyme-linked immunosorbent assay
Other: immunohistochemistry staining method
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Period Title: Overall Study
Started 26
Completed 24
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             1
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  53.8%
>=65 years
12
  46.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
62.4  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
3
  11.5%
Male
23
  88.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  11.5%
White
22
  84.6%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.8%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description 6 month PFS survival rate. Calculated as the total number of failures (deaths or progression) divided by the total follow-up or exposure time of patients on study. Assessed using Kaplan Meier and Proportional Hazards.
Time Frame The time from registration to documentation of disease progression up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description:

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28
(11 to 48)
2.Primary Outcome
Title Number of Participants With Clinical Response
Hide Description Number of participants with clinical response. Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors ver 1.0 Committee [JNCI 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST ver. 1.0 criteria.
Time Frame The time from registration up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description:

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Number of Participants With an Adverse Event.
Hide Description Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.
Time Frame The time from registration up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description:

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
26
 100.0%
4.Secondary Outcome
Title Median Progression Free Survival
Hide Description Median progression free survival. Assessed using Kaplan Meier and Proportional Hazards.
Time Frame The time from registration up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description:

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(2.1 to 6.0)
5.Secondary Outcome
Title 6-month Overall Survival Rate
Hide Description 6-month overall survival rate
Time Frame The time from registration up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients. Assessed using Kaplan Meier and Proportional Hazards.
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description:

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96
(76 to 99)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: Oral Panobinostat and Oral Everolimus
Hide Arm/Group Description

Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

panobinostat: Given orally

everolimus: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

liquid chromatography: Correlative studies

mass spectrometry: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

immunohistochemistry staining method: Correlative studies

All-Cause Mortality
Arm I: Oral Panobinostat and Oral Everolimus
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Arm I: Oral Panobinostat and Oral Everolimus
Affected / at Risk (%) # Events
Total   9/26 (34.62%)    
Blood and lymphatic system disorders   
Thrombocytopenia   1/26 (3.85%)  2
Cardiac disorders   
Atrial fibrillation   1/26 (3.85%)  2
Supraventricular tachycardia   1/26 (3.85%)  2
Gastrointestinal disorders   
Abdominal hernia   1/26 (3.85%)  2
Abdominal pain lower   1/26 (3.85%)  2
General disorders   
Disease progression   1/26 (3.85%)  2
Infections and infestations   
Pneumocystis jiroveci pneumonia   1/26 (3.85%)  2
Pneumonia   1/26 (3.85%)  2
Injury, poisoning and procedural complications   
Contusion   1/26 (3.85%)  2
Metabolism and nutrition disorders   
Dehydration   1/26 (3.85%)  2
Musculoskeletal and connective tissue disorders   
Muscular weakness   1/26 (3.85%)  2
Psychiatric disorders   
Confusional state   1/26 (3.85%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   1/26 (3.85%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I: Oral Panobinostat and Oral Everolimus
Affected / at Risk (%) # Events
Total   26/26 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   1/26 (3.85%)  6
Leukopenia   2/26 (7.69%)  4
Lymphadenopathy   1/26 (3.85%)  2
Neutropenia   3/26 (11.54%)  8
Thrombocytopenia   6/26 (23.08%)  28
Cardiac disorders   
Atrial fibrillation   2/26 (7.69%)  6
Eye disorders   
Ocular hyperaemia   1/26 (3.85%)  2
Photophobia   1/26 (3.85%)  2
Visual impairment   1/26 (3.85%)  2
Gastrointestinal disorders   
Abdominal distension   1/26 (3.85%)  2
Abdominal pain   2/26 (7.69%)  8
Abdominal pain lower   1/26 (3.85%)  2
Constipation   3/26 (11.54%)  6
Diarrhoea   7/26 (26.92%)  22
Dry mouth   1/26 (3.85%)  2
Dyspepsia   2/26 (7.69%)  4
Flatulence   1/26 (3.85%)  2
Mouth ulceration   2/26 (7.69%)  4
Nausea   6/26 (23.08%)  16
Stomatitis   3/26 (11.54%)  6
Tongue ulceration   1/26 (3.85%)  2
Vomiting   2/26 (7.69%)  6
General disorders   
Chills   4/26 (15.38%)  8
Fatigue   14/26 (53.85%)  30
Mucosal inflammation   8/26 (30.77%)  20
Oedema   1/26 (3.85%)  2
Oedema peripheral   5/26 (19.23%)  10
Pain   3/26 (11.54%)  8
Pyrexia   1/26 (3.85%)  2
Infections and infestations   
Cellulitis   1/26 (3.85%)  2
Cystitis   1/26 (3.85%)  2
Nasopharyngitis   1/26 (3.85%)  2
Pneumonia   1/26 (3.85%)  4
Upper respiratory tract infection   1/26 (3.85%)  2
Urethritis   1/26 (3.85%)  2
Injury, poisoning and procedural complications   
Contusion   1/26 (3.85%)  2
Muscle strain   1/26 (3.85%)  2
Investigations   
Alanine aminotransferase increased   1/26 (3.85%)  2
Aspartate aminotransferase increased   3/26 (11.54%)  8
Blood albumin decreased   1/26 (3.85%)  2
Blood alkaline phosphatase increased   3/26 (11.54%)  6
Blood calcium decreased   1/26 (3.85%)  2
Blood creatinine increased   5/26 (19.23%)  16
Blood fibrinogen increased   1/26 (3.85%)  4
Blood magnesium increased   2/26 (7.69%)  4
Blood phosphorus   2/26 (7.69%)  6
Blood phosphorus decreased   2/26 (7.69%)  6
Blood triglycerides increased   5/26 (19.23%)  34
Body temperature increased   1/26 (3.85%)  2
Electrocardiogram QT interval   1/26 (3.85%)  2
Electrocardiogram QT prolonged   2/26 (7.69%)  4
Gamma-glutamyltransferase increased   2/26 (7.69%)  4
Haemoglobin decreased   4/26 (15.38%)  20
High density lipoprotein decreased   1/26 (3.85%)  2
Low density lipoprotein increased   1/26 (3.85%)  2
Platelet count decreased   1/26 (3.85%)  2
Protein total increased   1/26 (3.85%)  2
White blood cell count decreased   1/26 (3.85%)  12
Metabolism and nutrition disorders   
Decreased appetite   4/26 (15.38%)  10
Dehydration   1/26 (3.85%)  4
Hypercholesterolaemia   3/26 (11.54%)  12
Hyperglycaemia   6/26 (23.08%)  26
Hyperkalaemia   1/26 (3.85%)  2
Hyperlipidaemia   1/26 (3.85%)  2
Hypermagnesaemia   1/26 (3.85%)  4
Hypernatraemia   1/26 (3.85%)  2
Hypertriglyceridaemia   1/26 (3.85%)  2
Hypoalbuminaemia   1/26 (3.85%)  6
Hypokalaemia   1/26 (3.85%)  2
Hyponatraemia   3/26 (11.54%)  6
Hypophosphataemia   1/26 (3.85%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia   4/26 (15.38%)  8
Back pain   2/26 (7.69%)  4
Bursitis   1/26 (3.85%)  2
Groin pain   1/26 (3.85%)  2
Musculoskeletal chest pain   1/26 (3.85%)  2
Musculoskeletal pain   2/26 (7.69%)  6
Myalgia   1/26 (3.85%)  4
Pain in extremity   5/26 (19.23%)  12
Pain in jaw   1/26 (3.85%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm malignant   1/26 (3.85%)  2
Nervous system disorders   
Dysgeusia   2/26 (7.69%)  4
Headache   4/26 (15.38%)  10
Hemicephalalgia   1/26 (3.85%)  2
Hypogeusia   1/26 (3.85%)  2
Neuropathy peripheral   1/26 (3.85%)  2
Peripheral motor neuropathy   1/26 (3.85%)  2
Tremor   3/26 (11.54%)  6
Psychiatric disorders   
Insomnia   1/26 (3.85%)  2
Renal and urinary disorders   
Dysuria   1/26 (3.85%)  2
Nocturia   1/26 (3.85%)  2
Proteinuria   1/26 (3.85%)  2
Urinary incontinence   1/26 (3.85%)  2
Reproductive system and breast disorders   
Erectile dysfunction   1/26 (3.85%)  2
Respiratory, thoracic and mediastinal disorders   
Cough   4/26 (15.38%)  8
Dyspnoea   5/26 (19.23%)  10
Epistaxis   2/26 (7.69%)  4
Pleuritic pain   1/26 (3.85%)  2
Pneumonitis   3/26 (11.54%)  8
Pulmonary embolism   1/26 (3.85%)  2
Pulmonary haemorrhage   1/26 (3.85%)  2
Skin and subcutaneous tissue disorders   
Alopecia   2/26 (7.69%)  4
Hyperhidrosis   1/26 (3.85%)  2
Nail disorder   1/26 (3.85%)  2
Pruritus   1/26 (3.85%)  2
Rash   3/26 (11.54%)  6
Rash generalised   1/26 (3.85%)  2
Rash macular   1/26 (3.85%)  2
Skin lesion   1/26 (3.85%)  2
Skin ulcer   1/26 (3.85%)  2
Vascular disorders   
Deep vein thrombosis   1/26 (3.85%)  2
Embolism   1/26 (3.85%)  2
Hypertension   1/26 (3.85%)  2
Hypotension   3/26 (11.54%)  8
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01582009    
Obsolete Identifiers: NCT01037257
Other Study ID Numbers: I146308
NCI-2009-01599 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 15, 2010
First Posted: April 20, 2012
Results First Submitted: April 7, 2017
Results First Posted: May 17, 2017
Last Update Posted: June 14, 2017