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Ascending Doses of AZD6738 in Combination With Chemotherapy and/or Novel Anti Cancer Agents

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ClinicalTrials.gov Identifier: NCT02264678
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE July 30, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE October 31, 2014
Estimated Primary Completion Date April 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Safety and tolerability in terms of AE and SAE (including death), as recorded in safety measures. [ Time Frame: From baseline until 28 days after discontinuation of study treatment. ]
Safety measures include AEs, SAEs, ECG, physical examination, pulse, blood pressure, body temperature, weight and laboratory variables
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02264678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Maximum Observed Plasma Concentration (Cmax) of AZD6738 [ Time Frame: At predefined intervals throughout the AZD6738 treatment period (approximately 8 weeks for Module 1 and 16 weeks + IP disc. for Module 2+3) ]
    Blood samples will be collected to assess plasma concentration of AZD6738 at a series of time points to derive Cmax.
  • Time to observed Cmax (Tmax) for AZD6738 [ Time Frame: At predefined intervals throughout the AZD6738 treatment period (approximately 8 weeks for Module 1 and 16 weeks + IP disc. for Module 2+3) ]
    Blood samples will be collected to assess plasma concentration of AZD6738 at a series of time points to derive Tmax.
  • Area under the plasma concentration-time curve (AUC) for AZD6738 [ Time Frame: At predefined intervals throughout the AZD6738 treatment period (approximately 8 weeks for Module 1 and 16 weeks + IP disc. for Module 2+3) ]
    Blood samples will be collected to assess plasma concentration of AZD6738 at a series of time points to derive AUC.
  • Maximum Observed Plasma Concentration (Cmax) of Carboplatin [ Time Frame: At predefined intervals throughout the Carboplatin treatment period (approximately 4 weeks for Module 1) ]
    Blood samples will be collected to assess plasma concentration of Carboplatin at a series of time points to derive Cmax.
  • Time to observed Cmax (Tmax) for Carboplatin [ Time Frame: At predefined intervals throughout the Carboplatin treatment period (approximately 4 weeks for Module 1) ]
    Blood samples will be collected to assess plasma concentration of Carboplatin at a series of time points to derive Tmax.
  • Area under the plasma concentration-time curve (AUC) for Carboplatin [ Time Frame: At predefined intervals throughout the Carboplatin treatment period (approximately 4 weeks for Module 1) ]
    Blood samples will be collected to assess plasma concentration of Carboplatin at a series of time points to derive AUC.
  • Maximum Observed Plasma Concentration (Cmax) of Olaparib [ Time Frame: At predefined intervals throughout the Olaparib treatment period (approximately 12 weeks for Module 2) ]
    Blood samples will be collected to assess plasma concentration of Olaparib at a series of time points to derive Cmax.
  • Time to observed Cmax (Tmax) for Olaparib [ Time Frame: At predefined intervals throughout the Olaparib treatment period (approximately 12 weeks for Module 2) ]
    Blood samples will be collected to assess plasma concentration of Olaparib at a series of time points to derive Tmax.
  • Area under the plasma concentration-time curve (AUC) for Olaparib [ Time Frame: At predefined intervals throughout the Olaparib treatment period (approximately 12 weeks for Module 2) ]
    Blood samples will be collected to assess plasma concentration of Olaparib at a series of time points to derive AUC.
  • Maximum Observed Plasma Concentration (Cmax) of MEDI4736 [ Time Frame: At predefined intervals throughout the MEDI4736 treatment period (approximately 28 weeks + 90days post IP disc. for Module 3) ]
    Blood samples will be collected to assess plasma concentration of MEDI4736 at a series of time points to derive Cmax.
  • Time to observed Cmax (Tmax) for MEDI4736 [ Time Frame: At predefined intervals throughout the MEDI4736 treatment period (approximately 28 weeks + 90days post IP disc. for Module 3) ]
    Blood samples will be collected to assess plasma concentration of MEDI4736 at a series of time points to derive Tmax.
  • Area under the plasma concentration-time curve (AUC) for MEDI4736 [ Time Frame: At predefined intervals throughout the MEDI4736 treatment period (approximately 28 weeks + 90days post IP disc. for Module 3) ]
    Blood samples will be collected to assess plasma concentration of MEDI4736 at a series of time points to derive AUC.
  • Assessment of pharmacodynamic biomarker changes [ Time Frame: Biopsies of tumour at baseline, last day of dosing and following progression of disease ]
    Evaluation of AZD6738 activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to functional ATR inhibition, ctDNA and CTCs.
  • Best objective response [ Time Frame: At baseline and every 6 weeks (module 1) and every 8 weeks (module 2 & 3) until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin (module 1), olaparib (module 2) and durvulamab (module 3)by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Objective response rate [ Time Frame: At baseline and every 6 weeks (module 1) and every 8 weeks (module 2 & 3) until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin (module 1) and olaparib (module 2) and MEDI4736 (module 3) by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Percentage change in tumour size [ Time Frame: At baseline and every 6 weeks (module 1) and every 8 weeks (module 2 & 3) until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin (module 1) and olaparib (module 2) and MEDI4736 (module 3) by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Durable response rate [ Time Frame: At baseline and every 6 weeks (module 1) and every 8 weeks (module 2 & 3) until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin (module 1) and olaparib (module 2) and MEDI4736 (module 3) by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Progression free survival [ Time Frame: At baseline and every 6 weeks (module 1) and every 8 weeks (module 2 & 3) until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin (module 1) and olaparib (module 2) and MEDI4736 (module 3) by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Survival assessment /status [ Time Frame: Every 8 weeks (+/- 1 week) after objective disease progression ]
    Module 2 only. To be obtained for all patients with gastric adenocarcinoma who received AZD6738 and olaparib in part A2, B1, B2, B3 and B4
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
  • Assessment of pharmacodynamic biomarker changes [ Time Frame: Biopsies of tumour at baseline, last day of dosing and following progression of disease ]
    Evaluation of AZD6738 activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to functional ATR inhibition, ctDNA and CTCs.
  • Cmax after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing when given orally in combination with carboplatin.
  • Tmax after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • Terminal rate constant after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • Terminal rate half life after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • AUC 0-12 hours after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • AUC 0-24 hours after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • AUC 0-t after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • AUC after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • CL/F after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • Apparent volume of distribution after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • MRT after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • CLR after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • Amount of drug excreted unchanged after single dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified on cycle 0 day 1 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after single dosing, when given orally.
  • Css max after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • Tss max after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • Css min after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • AUCss after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • CLss/F after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • RAC after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • Time dependency of the pharmacokinetics after multiple dosing [ Time Frame: Blood samples will be collected from each subject at pre-specified times on cycle 1 day 20 up to 24 hours ]
    To characterise the pharmacokinetics of AZD6738 and the active metabolite after multiple dosing when given orally in combination with carboplatin.
  • Best objective response [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Objective response rate [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Percentage change in tumour size [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Durable response rate [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
  • Progression free survival [ Time Frame: At baseline and every 6 weeks until disease progression or withdrawal from study ]
    To obtain a preliminary assessment of the anti-tumour activity of the combination of AZD6738 and carboplatin by evaluation of tumour response (objective response rate, duration of response, change in tumour size) and progression free survival using RECIST version 1.1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ascending Doses of AZD6738 in Combination With Chemotherapy and/or Novel Anti Cancer Agents
Official Title  ICMJE A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.
Brief Summary This is a modular, phase I/ phase 1 b, open-label, multicentre study of AZD6738 administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of AZD6738 with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is AZD6738 with carboplatin. The second combination to be investigated is AZD6738 with Olaparib. The third combination to be investigated is AZD6738 with MEDI4736.
Detailed Description This is a modular, phase I, 2 part, open-label, multicentre study of AZD6738, administered orally, in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced/metastatic solid malignancies. The study design allows an escalation of the dose of AZD6738 in combination with the standard dose and schedule of either cytotoxic chemotherapies and/or novel anti-cancer agents, with intensive safety monitoring to ensure the safety of the patients. There are two parts to each combination module of this study; part A, dose escalation and an optional part B, cohort expansions in particular patient groups. The initial combination module will be with Carboplatin (module 1). The second combination will be with Olaparib (module 2). The third combination will be with MEDI4736 (module 3). The option to start further combination modules will be the decision of the Safety Review Committee (SRC), based on emerging preclinical data and, safety and tolerability information from the initial combination. Combinations of AZD6738 with novel anti-cancer agents may also be explored. Once a minimally biologically active dose of AZD6738, for that combination module, has been identified from part A of that module, the SRC may decide to commence part B if deemed to be necessary. This may include cohort expansions of specific patient groups to explore preliminary anti-tumour activity or the effect of food or particular drug combinations on drug pharmacokinetics.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric & Breast Cancer
Intervention  ICMJE
  • Drug: Administration of AZD6738 in combination with carboplatin
    An oral formulation of AZD6738 will be used. In Module 1 Part A, patients will receive a single dose of AZD6738 on Day 1, followed by multiple dosing in combination with carboplatin. A maximum of 6 cycles (21 days per cycle) of treatment will be given. In Module 1 Part B, patients will receive AZD6738 and carboplatin at the dose, frequency and schedule recommended from Module 1 Part A.
  • Drug: Administration of AZD6738
    An oral formulation of AZD6738 will be used. In Module 2 Part A1, patients will receive a single dose of AZD6738 on Day 1, followed by 4 to 6 days washout, before multiple dosing.
  • Drug: Administration of AZD6738 in combination with olaparib
    An oral formulations of AZD6738 and olaparib will be used. In Module 2 Part A2, patients will receive a single dose of AZD6738 followed by 4 to 6 days washout, before multiple dosing with AZD6738 and olaparib. In Module 2 Part B, patients will receive AZD6738 and olaparib at the dose, frequency and schedule recommended from Module 2 Part A2.
  • Drug: Administation of AZD6738 in combination with MEDI4736
    An oral formulation of AZD6738 will be used. MEDI4736 is given via IV infusion. In Module 3 Part A patients will receive and initial single dose of AZD6738 on Day 1, followed by multiple dosing in combination with MEDI4736. In Module 3 Part B expansion cohorts will receive AZD6738 at the dose, frequency and schedule recommended from Module 3 Part A, in combination with MEDI4736.
Study Arms  ICMJE
  • Experimental: Module 1 Part A
    Module 1 Part A: ascending doses of AZD6738 in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
    Intervention: Drug: Administration of AZD6738 in combination with carboplatin
  • Experimental: Module 1 Part B
    Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive AZD6738 and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
    Intervention: Drug: Administration of AZD6738 in combination with carboplatin
  • Experimental: Module 2 Part A1
    Module 2 Part A1: ascending doses of AZD6738 will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
    Intervention: Drug: Administration of AZD6738
  • Experimental: Module 2 Part A2
    Module 2 Part A2: ascending doses of AZD6738 will be administered in combination with olaparib to patients to define the dose, frequency and schedule of AZD6738 and olaparib to take into Module 2 Part B.
    Intervention: Drug: Administration of AZD6738 in combination with olaparib
  • Experimental: Module 2 Part B1
    Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
    Intervention: Drug: Administration of AZD6738 in combination with olaparib
  • Experimental: Module 2 Part B2
    Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
    Intervention: Drug: Administration of AZD6738 in combination with olaparib
  • Experimental: Module 2 Part B3
    Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
    Intervention: Drug: Administration of AZD6738 in combination with olaparib
  • Experimental: Module 2 Part B4
    Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
    Intervention: Drug: Administration of AZD6738 in combination with olaparib
  • Experimental: Module 3 Part A
    Module 3 Part A: cohort escalation of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients to define the dose, frequency and schedule of AZD6738 and MEDI4736 to take into Module 3 Part B.
    Intervention: Drug: Administation of AZD6738 in combination with MEDI4736
  • Experimental: Module 3 Part B
    Module 3 Part B: cohort expansions of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
    Intervention: Drug: Administation of AZD6738 in combination with MEDI4736
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2018)
250
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2014)
119
Estimated Study Completion Date  ICMJE April 21, 2021
Estimated Primary Completion Date April 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Principal Inclusion criteria:

  • Aged at least 18
  • The presence of a solid malignant tumour that is not considered appropriate for further standard treatment
  • Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan
  • Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.
  • Module 2 Part B All - No previous treatment with PARP inhibitor.
  • Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours
  • Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours
  • Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer
  • Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma

Principal exclusion criteria

  • A diagnosis of ataxia telangiectasia
  • Prior exposure to an ATR inhibitor
  • Bad reaction to AZD6738
  • Module 1: Contra-indicated for treatment with carboplatin
  • Module 2: Contra-indicated for treatment with olaparib
  • Module 3: Contra-indicated for treatment with MEDI4736
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 677 400 4656 astrazeneca@emergingmed.com
Listed Location Countries  ICMJE France,   Korea, Republic of,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02264678
Other Study ID Numbers  ICMJE D5330C00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP