Trial Outcomes & Findings for 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 (NCT NCT01582009)
NCT ID: NCT01582009
Last Updated: 2022-08-15
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
The time from registration to documentation of disease progression up to 3 years
Results posted on
2022-08-15
Participant Flow
Participant milestones
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
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 Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
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 Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: The time from registration to documentation of disease progression up to 3 yearsPopulation: All treated and eligible patients
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.
Outcome measures
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 Participants
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
|
|---|---|
|
Progression-free Survival (PFS)
|
28 percentage of participants
Interval 11.0 to 48.0
|
PRIMARY outcome
Timeframe: The time from registration up to 3 yearsPopulation: All treated and eligible patients
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.
Outcome measures
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 Participants
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
|
|---|---|
|
Number of Participants With Clinical Response
|
0 Participants
|
SECONDARY outcome
Timeframe: The time from registration up to 3 yearsPopulation: All treated and eligible patients
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 Participants
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
|
|---|---|
|
Number of Participants With an Adverse Event.
|
26 Participants
|
SECONDARY outcome
Timeframe: The time from registration up to 3 yearsPopulation: All treated and eligible patients
Median progression free survival. Assessed using Kaplan Meier and Proportional Hazards.
Outcome measures
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 Participants
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
|
|---|---|
|
Median Progression Free Survival
|
5.3 months
Interval 2.1 to 6.0
|
SECONDARY outcome
Timeframe: The time from registration up to 3 yearsPopulation: All treated and eligible patients. Assessed using Kaplan Meier and Proportional Hazards.
6-month overall survival rate
Outcome measures
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 Participants
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
|
|---|---|
|
6-month Overall Survival Rate
|
96 percentage of participants
Interval 76.0 to 99.0
|
Adverse Events
Arm I: Oral Panobinostat and Oral Everolimus
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
1/26 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal hernia
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.8%
1/26 • Number of events 2
|
|
General disorders
Disease progression
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
1/26 • Number of events 2
|
|
Psychiatric disorders
Confusional state
|
3.8%
1/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Number of events 2
|
Other adverse events
| Measure |
Arm I: Oral Panobinostat and Oral Everolimus
n=26 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
2/26 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.8%
1/26 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.5%
3/26 • Number of events 8
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.1%
6/26 • Number of events 28
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
2/26 • Number of events 6
|
|
Eye disorders
Ocular hyperaemia
|
3.8%
1/26 • Number of events 2
|
|
Eye disorders
Photophobia
|
3.8%
1/26 • Number of events 2
|
|
Eye disorders
Visual impairment
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
2/26 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
26.9%
7/26 • Number of events 22
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
2/26 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.7%
2/26 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
23.1%
6/26 • Number of events 16
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
3/26 • Number of events 6
|
|
Gastrointestinal disorders
Tongue ulceration
|
3.8%
1/26 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 6
|
|
General disorders
Chills
|
15.4%
4/26 • Number of events 8
|
|
General disorders
Fatigue
|
53.8%
14/26 • Number of events 30
|
|
General disorders
Mucosal inflammation
|
30.8%
8/26 • Number of events 20
|
|
General disorders
Oedema
|
3.8%
1/26 • Number of events 2
|
|
General disorders
Oedema peripheral
|
19.2%
5/26 • Number of events 10
|
|
General disorders
Pain
|
11.5%
3/26 • Number of events 8
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Cystitis
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • Number of events 2
|
|
Infections and infestations
Urethritis
|
3.8%
1/26 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Number of events 2
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
11.5%
3/26 • Number of events 8
|
|
Investigations
Blood albumin decreased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
11.5%
3/26 • Number of events 6
|
|
Investigations
Blood calcium decreased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
19.2%
5/26 • Number of events 16
|
|
Investigations
Blood fibrinogen increased
|
3.8%
1/26 • Number of events 4
|
|
Investigations
Blood magnesium increased
|
7.7%
2/26 • Number of events 4
|
|
Investigations
Blood phosphorus
|
7.7%
2/26 • Number of events 6
|
|
Investigations
Blood phosphorus decreased
|
7.7%
2/26 • Number of events 6
|
|
Investigations
Blood triglycerides increased
|
19.2%
5/26 • Number of events 34
|
|
Investigations
Body temperature increased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Electrocardiogram QT interval
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Electrocardiogram QT prolonged
|
7.7%
2/26 • Number of events 4
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
2/26 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
15.4%
4/26 • Number of events 20
|
|
Investigations
High density lipoprotein decreased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Low density lipoprotein increased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Platelet count decreased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
Protein total increased
|
3.8%
1/26 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
3.8%
1/26 • Number of events 12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
4/26 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
1/26 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.5%
3/26 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
23.1%
6/26 • Number of events 26
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
3.8%
1/26 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
1/26 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.8%
1/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.5%
3/26 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.8%
1/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
4/26 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.8%
1/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.8%
1/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
1/26 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
2/26 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.2%
5/26 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.8%
1/26 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
3.8%
1/26 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
7.7%
2/26 • Number of events 4
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Number of events 10
|
|
Nervous system disorders
Hemicephalalgia
|
3.8%
1/26 • Number of events 2
|
|
Nervous system disorders
Hypogeusia
|
3.8%
1/26 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
3.8%
1/26 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.8%
1/26 • Number of events 2
|
|
Nervous system disorders
Tremor
|
11.5%
3/26 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
3.8%
1/26 • Number of events 2
|
|
Renal and urinary disorders
Nocturia
|
3.8%
1/26 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
1/26 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
3.8%
1/26 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.8%
1/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
5/26 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
2/26 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.8%
1/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.5%
3/26 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.8%
1/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
2/26 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
3/26 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.8%
1/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.8%
1/26 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
3.8%
1/26 • Number of events 2
|
|
Vascular disorders
Embolism
|
3.8%
1/26 • Number of events 2
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Number of events 2
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • Number of events 8
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place