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Trial record 55 of 841 for:    Advanced | Neuroendocrine Tumors

RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

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ClinicalTrials.gov Identifier: NCT01317615
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Large Cell
Neuroendocrine Tumors
Interventions Drug: RAD001
Drug: Paclitaxel
Drug: Carboplatin
Enrollment 49
Recruitment Details This was an open-label, single arm study.
Pre-assignment Details  
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Period Title: Overall Study
Started 49
Completed 0
Not Completed 49
Reason Not Completed
Disease progression             25
New cancer therapy             5
Death             6
Withdrawal by Subject             5
Abnormal laboratory value(s)             1
Adverse Event             7
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
62  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
14
  28.6%
Male
35
  71.4%
1.Primary Outcome
Title Percentage of Participants Progression-free
Hide Description Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description:
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Percentage of participants
49.0
2.Secondary Outcome
Title Percentage of Participants Progression-free
Hide Description Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description:
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Percentage of participants
8.2
3.Secondary Outcome
Title Percentage of Participants With Overall Response Rate (ORR)
Hide Description ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description:
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Percentage of participants
44.9
4.Secondary Outcome
Title Percentage of Participants With Disease Control Rate (DCR)
Hide Description DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description:
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: Percentage of participants
73.5
5.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description:
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
132
(97 to 181)
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from date of start of treatment to date of death due to any cause.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description:
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
298
(207 to 351)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAD001 Plus Paclitaxel/Carboplatin
Hide Arm/Group Description Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
All-Cause Mortality
RAD001 Plus Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RAD001 Plus Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   28/49 (57.14%) 
Blood and lymphatic system disorders   
ANAEMIA  1  1/49 (2.04%) 
FEBRILE NEUTROPENIA  1  1/49 (2.04%) 
NEUTROPENIA  1  1/49 (2.04%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  2/49 (4.08%) 
Ear and labyrinth disorders   
VERTIGO  1  1/49 (2.04%) 
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/49 (2.04%) 
ABDOMINAL PAIN UPPER  1  2/49 (4.08%) 
COLITIS  1  1/49 (2.04%) 
CONSTIPATION  1  2/49 (4.08%) 
DIARRHOEA  1  1/49 (2.04%) 
GASTRITIS  1  1/49 (2.04%) 
GASTROINTESTINAL HAEMORRHAGE  1  1/49 (2.04%) 
NAUSEA  1  1/49 (2.04%) 
General disorders   
FATIGUE  1  1/49 (2.04%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  5/49 (10.20%) 
MULTI-ORGAN FAILURE  1  1/49 (2.04%) 
PAIN  1  2/49 (4.08%) 
Hepatobiliary disorders   
ACUTE HEPATIC FAILURE  1  1/49 (2.04%) 
HEPATOMEGALY  1  1/49 (2.04%) 
Infections and infestations   
CLOSTRIDIAL INFECTION  1  1/49 (2.04%) 
EMPYEMA  1  1/49 (2.04%) 
EPIDIDYMITIS  1  1/49 (2.04%) 
GASTROENTERITIS  1  1/49 (2.04%) 
INFECTION  1  1/49 (2.04%) 
PNEUMONIA  1  3/49 (6.12%) 
PYOPNEUMOTHORAX  1  1/49 (2.04%) 
SEPSIS  1  2/49 (4.08%) 
SINUSITIS  1  1/49 (2.04%) 
Investigations   
C-REACTIVE PROTEIN INCREASED  1  1/49 (2.04%) 
Metabolism and nutrition disorders   
DEHYDRATION  1  2/49 (4.08%) 
HYPONATRAEMIA  1  2/49 (4.08%) 
Musculoskeletal and connective tissue disorders   
PAIN IN JAW  1  1/49 (2.04%) 
SPINAL PAIN  1  1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BENIGN NEOPLASM OF THYROID GLAND  1  1/49 (2.04%) 
BRONCHIAL CARCINOMA  1  1/49 (2.04%) 
MALIGNANT NEOPLASM PROGRESSION  1  1/49 (2.04%) 
METASTASES TO CENTRAL NERVOUS SYSTEM  1  1/49 (2.04%) 
PARANEOPLASTIC SYNDROME  1  1/49 (2.04%) 
Nervous system disorders   
SCIATICA  1  1/49 (2.04%) 
VOCAL CORD PARESIS  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA  1  5/49 (10.20%) 
HAEMOPTYSIS  1  1/49 (2.04%) 
PLEURAL EFFUSION  1  3/49 (6.12%) 
PNEUMOTHORAX  1  3/49 (6.12%) 
PULMONARY EMBOLISM  1  1/49 (2.04%) 
RESPIRATORY FAILURE  1  1/49 (2.04%) 
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%
RAD001 Plus Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   43/49 (87.76%) 
Blood and lymphatic system disorders   
ANAEMIA  1  14/49 (28.57%) 
LEUKOPENIA  1  7/49 (14.29%) 
NEUTROPENIA  1  10/49 (20.41%) 
THROMBOCYTOPENIA  1  8/49 (16.33%) 
Eye disorders   
VISUAL IMPAIRMENT  1  3/49 (6.12%) 
Gastrointestinal disorders   
ABDOMINAL PAIN UPPER  1  3/49 (6.12%) 
CONSTIPATION  1  9/49 (18.37%) 
DIARRHOEA  1  10/49 (20.41%) 
DYSPHAGIA  1  3/49 (6.12%) 
NAUSEA  1  13/49 (26.53%) 
STOMATITIS  1  8/49 (16.33%) 
General disorders   
ASTHENIA  1  4/49 (8.16%) 
CHEST PAIN  1  3/49 (6.12%) 
FATIGUE  1  17/49 (34.69%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  3/49 (6.12%) 
MUCOSAL INFLAMMATION  1  8/49 (16.33%) 
OEDEMA PERIPHERAL  1  7/49 (14.29%) 
PAIN  1  6/49 (12.24%) 
PERIPHERAL SWELLING  1  4/49 (8.16%) 
PYREXIA  1  3/49 (6.12%) 
Infections and infestations   
INFECTION  1  4/49 (8.16%) 
Investigations   
WEIGHT DECREASED  1  8/49 (16.33%) 
WHITE BLOOD CELL COUNT DECREASED  1  3/49 (6.12%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  10/49 (20.41%) 
HYPOKALAEMIA  1  5/49 (10.20%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  5/49 (10.20%) 
GROWING PAINS  1  3/49 (6.12%) 
PAIN IN EXTREMITY  1  3/49 (6.12%) 
Nervous system disorders   
HEADACHE  1  6/49 (12.24%) 
HYPOAESTHESIA  1  3/49 (6.12%) 
PARAESTHESIA  1  7/49 (14.29%) 
POLYNEUROPATHY  1  9/49 (18.37%) 
Psychiatric disorders   
INSOMNIA  1  3/49 (6.12%) 
SLEEP DISORDER  1  5/49 (10.20%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  8/49 (16.33%) 
DYSPHONIA  1  3/49 (6.12%) 
DYSPNOEA  1  13/49 (26.53%) 
OROPHARYNGEAL PAIN  1  3/49 (6.12%) 
Skin and subcutaneous tissue disorders   
ALOPECIA  1  12/49 (24.49%) 
NIGHT SWEATS  1  4/49 (8.16%) 
RASH  1  7/49 (14.29%) 
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01317615     History of Changes
Other Study ID Numbers: CRAD001KDE37
EudraCT 2010-022273-34 ( Registry Identifier: EudraCT )
2010-022273-34
First Submitted: March 16, 2011
First Posted: March 17, 2011
Results First Submitted: February 17, 2016
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016