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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02580058




Registration number
NCT02580058
Ethics application status
Date submitted
16/10/2015
Date registered
20/10/2015

Titles & IDs
Public title
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
Scientific title
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
Secondary ID [1] 0 0
2015-003091-77
Secondary ID [2] 0 0
B9991009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - avelumab
Treatment: Drugs - PLD

Experimental: avelumab - Arm A: avelumab alone

Experimental: avelumab plus pegylated liposomal doxorubicin (PLD) - Arm B: avelumab plus PLD

Active comparator: PLD - Arm C: PLD alone


Treatment: Other: avelumab
10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles

Treatment: Drugs: PLD
PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).
Primary outcome [2] 0 0
Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [2] 0 0
From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Based on BICR Assessment
Timepoint [1] 0 0
Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.
Secondary outcome [2] 0 0
ORR Based on Investigator Assessment
Timepoint [2] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [3] 0 0
PFS Based on Investigator Assessment According to RECIST Version 1.1
Timepoint [3] 0 0
From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.
Secondary outcome [4] 0 0
Duration of Response (DR) Based on BICR Assessment
Timepoint [4] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [5] 0 0
DR Based on Investigator Assessment
Timepoint [5] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [6] 0 0
Disease Control (DC) Rate Based on BICR Assessment
Timepoint [6] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [7] 0 0
DC Rate Based on Investigator Assessment
Timepoint [7] 0 0
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
Secondary outcome [8] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [8] 0 0
From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.
Secondary outcome [9] 0 0
Number of Participants With Laboratory Abnormalities
Timepoint [9] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [10] 0 0
Change From Baseline in Vital Signs - Blood Pressure
Timepoint [10] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [11] 0 0
Change From Baseline in Vital Signs - Pulse Rate
Timepoint [11] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [12] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timepoint [12] 0 0
From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.
Secondary outcome [13] 0 0
Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline
Timepoint [13] 0 0
Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
Secondary outcome [14] 0 0
Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS
Timepoint [14] 0 0
Biomarkers are measured only at screening.
Secondary outcome [15] 0 0
Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS
Timepoint [15] 0 0
Biomarkers are measured only at screening.
Secondary outcome [16] 0 0
Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL
Timepoint [16] 0 0
Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.
Secondary outcome [17] 0 0
Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28
Timepoint [17] 0 0
From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.
Secondary outcome [18] 0 0
Change From Baseline in EQ-VAS Score at End of Treatment
Timepoint [18] 0 0
Baseline and end of treatment/withdrawal visit
Secondary outcome [19] 0 0
Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose
Timepoint [19] 0 0
At predose (0 H) on Cycle 2 Day 1
Secondary outcome [20] 0 0
Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose
Timepoint [20] 0 0
At postdose (end of infusion, 1H) on Cycle 2 Day 1
Secondary outcome [21] 0 0
Cmax For Doxorubicin Following Cycle 2 Day 1 PLD Dose
Timepoint [21] 0 0
From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
Secondary outcome [22] 0 0
Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
Timepoint [22] 0 0
From 0 through 24 hours postdose
Secondary outcome [23] 0 0
Area Under The Concentration Time Profile From Time Zero to 336 Hours (AUC336) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
Timepoint [23] 0 0
From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
Secondary outcome [24] 0 0
Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
Timepoint [24] 0 0
From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
Secondary outcome [25] 0 0
Number of Participants With Treatment-Boosted Anti-Drug Antibody (ADA)
Timepoint [25] 0 0
At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab
Secondary outcome [26] 0 0
Number of Participants With Treatment-Induced ADA
Timepoint [26] 0 0
At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab
Secondary outcome [27] 0 0
Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)
Timepoint [27] 0 0
At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab

Eligibility
Key inclusion criteria
* Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
* Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
* Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
* Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.

Mandatory tumor biopsy must be performed prior to enrollment for all patients (unless there is a documented clinical contraindication). In addition, availability of archived FFPE tumor tissue should be confirmed. If a patient underwent tumor tissue collection within 3 months prior to enrollment with no intervening treatment, and the sample is provided, then a new de novo tumor biopsy is not required.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
* Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways).
* Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
* Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
* Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/07/2022
Sample size
Target
Accrual to date
Final
566
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Epic Pharmacy,Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Newcastle Private Hospital Pty Limited - Newcastle
Recruitment hospital [3] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [4] 0 0
Rivercity Pharmacy - Auchenflower
Recruitment hospital [5] 0 0
Mater Pharmacy Services - Brisbane
Recruitment hospital [6] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [7] 0 0
Clinical Research Unit - Herston
Recruitment hospital [8] 0 0
Metro North Hospital and Health Service - Herston
Recruitment hospital [9] 0 0
Oncology Pharmacy - Herston
Recruitment hospital [10] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [11] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [12] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [13] 0 0
Icon Cancer Care Southport - Southport
Recruitment hospital [14] 0 0
Cabrini Health Limited - Brighton
Recruitment hospital [15] 0 0
Cabrini Health Limited - Malvern
Recruitment hospital [16] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [18] 0 0
Pharmacy Department - Parkville
Recruitment hospital [19] 0 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
3186 - Brighton
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3000 - Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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Georgia
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United States of America
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Kentucky
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Massachusetts
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Missouri
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Nevada
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North Carolina
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Oregon
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Virginia
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Wisconsin
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Austria
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Graz
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Austria
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Innsbruck
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Belgium
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EAST Flanders
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Brussels
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Dublin 4
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Brescia
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Lecco
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Milano
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Ravenna
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Torino
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Como
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Piacenza
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Daegu
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Seoul
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Rybnik
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Russian Federation
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Russian Federation
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Russian Federation
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Krasnodar
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Nizhniy Novgorod
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Ticino
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Zurich
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Taiwan
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Tainan city
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Taiwan
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Tainan City
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Taiwan
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Taipei city
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
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Cambridgeshire
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United Kingdom
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CITY OF Glasgow
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United Kingdom
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Merseyside
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United Kingdom
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Middlesex
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United Kingdom
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Northamptonshire
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United Kingdom
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Oxford
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United Kingdom
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Surrey
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02580058