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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00924989
Registration number
NCT00924989
Ethics application status
Date submitted
17/06/2009
Date registered
19/06/2009
Date last updated
5/09/2018
Titles & IDs
Public title
A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
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Secondary ID [1]
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2009-012820-97
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Secondary ID [2]
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OSI-906-301
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Universal Trial Number (UTN)
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Trial acronym
GALACCTIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adrenocortical Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - OSI-906
Other interventions - Placebo
Experimental: Arm A: OSI-906 - 150 mg twice daily
Placebo Comparator: Arm B: Placebo - Matching placebo twice daily
Treatment: Drugs: OSI-906
Administered orally
Other interventions: Placebo
Matching placebo administered orally
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival of single agent OSI-906 versus placebo
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Assessment method [1]
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Time from date of randomization until time of documented death
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Timepoint [1]
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33 months
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Secondary outcome [1]
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Progression-free survival
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Assessment method [1]
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Time from randomization to disease progression based on RECIST version 1.1 or death due to any cause, whichever comes first
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Disease control rate
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Assessment method [2]
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Proportion of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD), based on RECIST criteria
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Best overall response rate
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Assessment method [3]
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Proportion of patients with a best overall response of CR or PR based on RECIST criteria
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Duration of response
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Assessment method [4]
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Time from date of the first documented response (CP/PR) to documented progression or death due to underlying cancer
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Time to deterioration in Quality of Life
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Assessment method [5]
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Measured by European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Safety assessed via physical exams, vital signs, laboratory assessments, electrocardiograms, and adverse events
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Assessment method [6]
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Timepoint [6]
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24 months
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Eligibility
Key inclusion criteria
- Histologically confirmed adrenocortical carcinoma that is locally advanced or
metastatic and not amenable to surgical resection.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
(version 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
- Predicted life expectancy >= 12 weeks.
- At least 1 but no more than 2 prior drug regimens (including molecular targeted
therapy, systemic cytotoxic chemotherapy, biologics, and/or vaccines) for locally
advanced/metastatic ACC.
- A minimum of 3 weeks must have elapsed between the end of prior treatment and
randomization.
- All patients must have received prior mitotane, either as neoadjuvant, adjuvant, or
locally advanced/metastatic therapy.
- Adjuvant and neoadjuvant mitotane therapy will not be counted as prior drug regimens
or as systemic cytotoxic chemotherapy.
- Prior radiation therapy is permitted provided patients have recovered from the acute,
toxic effects of radiotherapy prior to randomization.
- A minimum of 21 days must have elapsed between the end of radiotherapy and
randomization.
- Prior surgery is permitted provided that adequate wound healing has occurred prior to
randomization.
- Fasting glucose < = 150 mg/dL (8.3 mmol/L).
- Adequate hematopoietic, hepatic, and renal function defined as follows: Neutrophil
count >= 1.5 x 10^9 /L;
- Platelet count >= 100 x 10^9 /L;
- Bilirubin <= 1.5 x Upper Limit of Normal (ULN);
- AST and ALT <= 2.5 x ULN, or <= 5 x ULN if patient has documented liver metastases or
received prior mitotane therapy; and
- Serum creatinine <= 1.5 x ULN or <= 2.0 x ULN if the patient has received prior
cisplatin.
- Patients, both males and females, with reproductive potential (ie, menopausal for less
than 1 year and not surgically sterilized) must agree to practice effective
contraceptive measures throughout the study.
- Women of childbearing potential must provide a negative pregnancy test (serum or
urine) within 14 days prior to randomization.
- Patients must provide verbal and written informed consent to participate in the study.
- Radiologically-confirmed progressive disease within 6 months prior to randomization.
- Concurrent use of non-insulinotropic oral antihyperglycemic therapy is permitted if
the dose has been stable for >= 4 weeks at the time of randomization.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring
insulinotropic or insulin therapy.
- Prior IGF-1R inhibitor therapy.
- Malignancy other than ACC within the past 3 years. Exceptions: resected basal cell or
squamous cell carcinoma of the skin; cured in situ cervical carcinoma; cured ductal
carcinoma in situ of the breast; and/or cured superficial bladder cancer.
- History of significant cardiovascular disease unless the disease is well-controlled.
- Significant cardiac diseases includes second/third degree heart block; clinically
significant ischemic heart disease; mean QTcF interval > 450 msec at screening;
- poorly controlled hypertension; congestive heart failure of New York Heart Association
(NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest,
but ordinary physical activity results in fatigue, palpitation, or dyspnea).
- History of cerebrovascular accident (CVA) within 6 months prior to randomization or
that resulted in ongoing neurologic instability.
- Use of drugs that have a risk of causing QT interval prolongation within 14 days prior
to Day 1 dosing.
- Active infection or serious underlying medical condition (including any type of active
seizure disorder within 12 months prior to randomization) that would impair the
ability of the patient to receive study drug.
- History of any psychiatric condition that might impair the patient's ability to
understand or to comply with the requirements of the study or to provide informed
consent.
- Pregnant or breast-feeding females.
- Symptomatic brain metastases that are not stable, require steroids, are potentially
life threatening, or that have required radiation within 28 days prior to
randomization.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to study drug.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/10/2012
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Sample size
Target
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Accrual to date
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Final
139
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital Department of Endocrinology - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Florida
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Massachusetts
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Michigan
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New Hampshire
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North Carolina
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Ohio
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Tennessee
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Texas
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Canada
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Ontario
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Canada
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Quebec
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France
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State/province [14]
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Lille
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France
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Lyon
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France
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Marseille
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France
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Paris
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France
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Pessac
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France
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Villejuif
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Germany
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Berlin
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Germany
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Munich
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Germany
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Wuerzburg
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Italy
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Orbassano
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Italy
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Rome
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Amsterdam
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Eindhoven
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Rotterdam
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Poland
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Gliwice
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United Kingdom
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Leeds
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astellas Pharma Inc
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent
OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who
received at least 1 but no more than 2 prior drug regimens
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00924989
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Astellas Pharma Global Development
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00924989
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