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Trial record 15 of 172 for:    pertuzumab

A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02507375
Recruitment Status : Completed
First Posted : July 23, 2015
Results First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Erlotinib
Drug: Pertuzumab
Enrollment 17
Recruitment Details Seventeen patients enrolled in 3 centers. Three patients from cohort 1 and 1 patient from cohort 2 completed the 6 cycles of study therapy, as planned.
Pre-assignment Details Two participants in cohort 2 did not begin experimental study drug treatment in Cycle 1, so were not included in the analysis set.The resulting participant flow includes only participants who received pertuzumab.
Arm/Group Title Erlotinib 100 mg + Pertuzumab 420 mg Erlotinib 150 mg + Pertuzumab 420 mg
Hide Arm/Group Description Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
Period Title: Overall Study
Started 6 9 [1]
Cycle 1 6 9
Received Pertuzumab 6 6
Cycle 2 5 5
Cycle 3 4 5
Cycle 4 4 2
Cycle 5 3 1
Cycle 6 3 1
Extension Period 2 1
Completed 2 1
Not Completed 4 8
Reason Not Completed
Progressive Disease             4             5
Death             0             1
Refused treatment             0             1
Adverse Event             0             1
[1]
Two patients in cohort 2 did not begin treatment in Cycle 1 so were not included in the analysis set
Arm/Group Title Erlotinib 100 mg + Pertuzumab 420 mg Erlotinib 150 mg + Pertuzumab 420 mg Total
Hide Arm/Group Description Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously. Total of all reporting groups
Overall Number of Baseline Participants 6 9 15
Hide Baseline Analysis Population Description
All recruited participants who received at least 1 dose of both pertuzumab and erlotinib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 9 participants 15 participants
66.5  (5.89) 56.0  (10.28) 60.2  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 15 participants
Female
1
  16.7%
3
  33.3%
4
  26.7%
Male
5
  83.3%
6
  66.7%
11
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 15 participants
Belgium 1 0 1
United Kingdom 1 1 2
Spain 4 8 12
1.Primary Outcome
Title Percentage of Participants With Dose Limiting Toxicities (DLTs)
Hide Description A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.
Time Frame From baseline to end of the study (up to 42 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib 100 mg + Pertuzumab 420 mg Erlotinib 150 mg + Pertuzumab 420 mg
Hide Arm/Group Description:
Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
2.Secondary Outcome
Title Percentage of Participants Classified as Responders
Hide Description Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Time Frame within 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Total Population Erlotinib 100 mg + Pertuzumab 420 mg Erlotinib 150 mg + Pertuzumab 420 mg
Hide Arm/Group Description:
Erlotinib + pertuzumab
Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
Overall Number of Participants Analyzed 15 6 9
Measure Type: Number
Unit of Measure: percentage of participants
20 33.3 11.1
3.Secondary Outcome
Title Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6
Hide Description Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.
Time Frame From baseline to the end of the study (up to 42 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib 100 mg + Pertuzumab 420 mg Erlotinib 150 mg + Pertuzumab 420 mg
Hide Arm/Group Description:
Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
Overall Number of Participants Analyzed 6 9
Measure Type: Number
Unit of Measure: Percentage of participants
Cycle 1 0 0
Cycle 2 33.3 11.1
Cycle 3 0 0
Cycle 4 33.3 11.1
Cycle 6 16.7 11.1
4.Secondary Outcome
Title Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
Hide Description Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L.
Time Frame on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis subset, defined as all participants from either cohort with adequate data for performing PK analysis
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mg/L
231  (55.3)
5.Secondary Outcome
Title Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
Hide Description The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax).
Time Frame on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis subset
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: days
0.23  (0.11)
6.Secondary Outcome
Title Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
Hide Description Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.
Time Frame on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis subset with adequate data for this analysis
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: days
17.9  (2.18)
7.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC)
Hide Description Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person’s bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person’s bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf).
Time Frame on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis subset with appropriate data available
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mg*day/L
AUC(0-21 days) n=8 1780  (340)
AUC(0-inf) n=7 3000  (815)
8.Secondary Outcome
Title Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
Hide Description A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration.
Time Frame on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK subset
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: L/day
0.24  (0.05)
9.Secondary Outcome
Title Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC
Hide Description Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure.
Time Frame on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis subset
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Liters
4.9  (1.3)
Time Frame Timeframe was up to 42 weeks
Adverse Event Reporting Description All participants who received at least 1 dose of both pertuzumab and erlotinib and had at least 1 post-baseline safety follow-up.
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Erlotinib 100 mg + pertuzumab 420 mg Erlotinib 150 mg + pertuzumab 420 mg
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      4/9 (44.44%)    
Cardiac disorders     
Myocardial Infarction  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders     
Diarrhea  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung Cancer Malignant  1 [1]  0/6 (0.00%)  0 1/9 (11.11%)  1
Renal and urinary disorders     
Renal Failure Acute  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Vascular disorders     
Thrombosis  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
[1]
Sudden death due to progressive disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      9/9 (100.00%)    
Eye disorders     
Xerophthalmia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  3/6 (50.00%)  3 6/9 (66.67%)  6
Vomiting  1  0/6 (0.00%)  0 3/9 (33.33%)  3
Abdominal Pain Upper  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Dysphagia  1  0/6 (0.00%)  0 2/9 (22.22%)  2
Nausea  1  0/6 (0.00%)  0 2/9 (22.22%)  2
Abdominal Pain  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Anal Fissure  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Constipation  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Dyspepsia  1  0/6 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Asthenia  1  2/6 (33.33%)  2 3/9 (33.33%)  3
Mucosal Inflammation  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Axillary Pain  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Oedema  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Pain  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Hepatobiliary disorders     
Hepatotoxicity  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Infections and infestations     
Paronychia  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Fungal Infection  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Influenza  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Lung Infection  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Nail Infection  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Onychomycosis  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Oral Fungal Infection  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Tinea Pedis  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  2/6 (33.33%)  2 3/9 (33.33%)  3
Musculoskeletal and connective tissue disorders     
Bone Pain  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Musculoskeletal Pain  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders     
Headache  1  1/6 (16.67%)  1 4/9 (44.44%)  4
Lethargy  1  1/6 (16.67%)  1 1/9 (11.11%)  1
Neurotoxicity  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Peripheral Sensory Neuropathy  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders     
Depression  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Insomnia  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/6 (16.67%)  1 2/9 (22.22%)  2
Chronic Obstructive Pulmonary Disease  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Cough  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Epistaxis  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Haemoptysis  1  0/6 (0.00%)  0 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders     
Rash  1  6/6 (100.00%)  6 5/9 (55.56%)  5
Pruritus  1  4/6 (66.67%)  4 2/9 (22.22%)  2
Nail Bed Inflammation  1  0/6 (0.00%)  0 2/9 (22.22%)  2
Dry Skin  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Vascular disorders     
Hypertension  1  1/6 (16.67%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Per Version A the protocol was halted for 2 DLTs (grade 3 manageable rash common for erlotinib) in the first 6 patients. Ethics committee approved redefining DLT and starting anew with Version B. No further DLTs were observed throughout the study.
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.

The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02507375     History of Changes
Obsolete Identifiers: NCT02514096
Other Study ID Numbers: WO20024
First Submitted: July 14, 2015
First Posted: July 23, 2015
Results First Submitted: July 31, 2015
Results First Posted: October 16, 2015
Last Update Posted: October 16, 2015