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CompletedNCT02983799Updated Apr 13, 2022Results posted

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

A Phase 2 interventional study of OLAPARIB in Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity, sponsored by AstraZeneca. Completed at 47 sites in 2 countries. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
272
Allocation
Not applicable
Ages
18 Years to 130 Years
Sex
Female
01

Study summary

This is a non-randomized, open-label study to assess olaparib tablets as a treatment for subjects with different homologous recombination deficiency (HRD) tumor status and with platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer. Subjects should have received at least 1 prior line of platinum-based chemotherapy.

Read the detailed description

This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily (bid) in subjects with platinum-sensitive or partially platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received at least 1 prior line of platinum-based chemotherapy.

The study will assess the effectiveness of olaparib tablets as measured by the objective response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in subjects with germline BRCA mutations (gBRCAm), somatic BRCA mutations (sBRCAm), or potential aberrations in homologous recombination deficiency (HRD) as determined by myChoice® HRD, as well as in subjects without identifiable HRD. This study will utilize Myriad BRACAnalysis CDx® for germline BRCA analysis and a tumor test (myChoice® HRD) for tumor BRCA analysis and HRD status. Four cohorts will be identified based upon the genetic testing described above:

  • Cohort 1: gBRCAm,
  • Cohort 2: sBRCAm and germline BRCA wild type,
  • Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type (BRCAwt) (no BRCA mutation),
  • Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA mutation).
02

Conditions studied

  • Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Keywords

  • BRCA, ovarian, platinum, chemotherapy
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 272 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Provision of written signed informed consent prior to any study specific procedures;
  • Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer;
  • At least 1 lesion (measurable by RECIST v1.1) that can be accurately assessed at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
  • Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;
  • Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);
  • Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment;
  • ECOG performance status 0 to 1;
  • Subjects must have a life expectancy greater than or equal to 16 weeks;
  • Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1;
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations; and
  • Formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. If there is not written confirmation of the availability of an archived or fresh tumor sample prior to enrollment, the subject is not eligible for the study.

Exclusion criteria

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca Representative staff and/or staff at the study site);
  • Previous enrollment in the present study;
  • Exposure to any investigational product (IP) within 30 days or 5 half-lives (whichever is longer) prior to start of study treatment;
  • Any previous treatment with a PARP inhibitor, including olaparib;
  • Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
  • Other malignancy within the last 5 years (few exceptions apply);
  • Resting ECG with clinically significant abnormal findings;
  • Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
  • Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors;
  • Concomitant use of known strong or moderate CYP3A inducers;
  • Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia;
  • Subjects with MDS/AML or with features suggestive of MDS/AML;
  • Subjects with pneumonitis or at risk of pneumonitis;
  • Subjects with symptomatic uncontrolled brain metastases;
  • Major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery;
  • Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection;
  • Breast feeding women;
  • Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus;
  • Subjects with known active hepatitis (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
272 participants (actual)

Study arms

  • Experimental
    gBRCAm;

    germline BRCA mutant

    Drug: OLAPARIB

  • Experimental
    sBRCAm and germline BRCA wild type;

    somatic BRCA mutant, germline BRCA wild type

    Drug: OLAPARIB

  • Experimental
    myChoice® HRD positive and BRCAwt;

    genomic instability positive and no BRCA mutation

    Drug: OLAPARIB

  • Experimental
    myChoice® HRD negative and BRCAwt

    genomic instability negative and no BRCA mutation

    Drug: OLAPARIB

Interventions

  • DrugOLAPARIB

    300 mg olaparib tablets taken orally twice daily

06

What researchers measure

Primary outcomes

  1. Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)

    Time frame: From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)

Secondary outcomes

  1. Duration of Response, for Those Subjects With a Confirmed Response of CR or PR

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response

    Time frame: From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)

  2. CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate

    Time frame: From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)

  3. Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.

    Time frame: From first dose up until progression, or last evaluable assessment in the absence of progression

  4. Progression Free Survival

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival

    Time frame: From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)

  5. Time to Any Progression

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression

    Time frame: From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)

  6. Overall Survival

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival

    Time frame: From date of first dose to date of death from any cause (up to 48 months)

  7. HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)

    To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome

    Time frame: At baseline

07

Results

Posted Apr 13, 2022

Participant flow

Participant flow — Overall Study
MilestoneCOHORT 1COHORT 2COHORT 3COHORT 4Unassigned
Started7526689013
Completed25818143
Not completed5018507610
Withdrew: Withdrawn from study before data cut-off281223251
Withdrew: Death20523477
Withdrew: Withdrawal by subject10341
Withdrew: Protocol violation01001
Withdrew: Lost to follow-up10100

Outcome measures

PrimaryObjective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using ORR according to RECIST v1.1 criteria (Investigator determined)

Time frame:
From first dose up until progression, or last evaluable assessment in the absence of progression (up to 36 months)
Reported as:
Number · Percent
Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
PercentCohort 1Cohort 2COHORT 3COHORT 4Unassigned
Objective Response Rate, Defined as the Percentage of Subjects With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)69.3 (57.6 to 79.5)64.0 (42.5 to 82.0)29.4 (19.0 to 41.7)10.1 (4.7 to 18.3)30.8 (9.1 to 61.4)
SecondaryDuration of Response, for Those Subjects With a Confirmed Response of CR or PR

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using duration of response

Time frame:
From the date of the measurement criteria for CR or PR are first met until the date of documented progression or death in the absence of disease progression (up to 36 months)
Reported as:
Median · Months
Duration of Response, for Those Subjects With a Confirmed Response of CR or PR
MonthsCohort 1Cohort 2COHORT 3COHORT 4Unassigned
Duration of Response, for Those Subjects With a Confirmed Response of CR or PR9.4 (7.5 to 12.5)14.7 (5.7 to NA)10.0 (5.6 to NA)5.3 (3.7 to 7.3)7.5 (6.0 to NA)
SecondaryCA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using CA-125 response rate

Time frame:
From baseline to Day 1 of each cycle and end of study treatment visit (up to 36 months)
Reported as:
Number · Percent
CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response
PercentCohort 1Cohort 2COHORT 3COHORT 4Unassigned
CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response93.2 (81.3 to 98.6)70.0 (45.7 to 88.1)47.9 (33.3 to 62.8)26.6 (16.3 to 39.1)66.7 (34.9 to 90.1)
SecondaryDisease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using disease control rate (DCR). DCR is defined as the percentage of subjects with a best overall response of CR or PR (at any time up to and including the defined analysis cut-off point) or who have demonstrated stable disease (SD) for at least 8 weeks from first dose, divided by the number of subjects in the efficacy analysis set.

Time frame:
From first dose up until progression, or last evaluable assessment in the absence of progression
Reported as:
Number · Percent
Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event
PercentCohort 1Cohort 2COHORT 3COHORT 4Unassigned
Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event96.0 (88.8 to 99.2)100.0 (86.3 to 100.0)79.4 (67.9 to 88.3)75.3 (65.0 to 83.8)92.3 (64.0 to 99.8)
SecondaryProgression Free Survival

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using progression free survival

Time frame:
From first dose to earlier date of assessment of objective progression or death by any cause in the absence of progression (up to 36 months)
Reported as:
Median · Months
Progression Free Survival
MonthsCohort 1Cohort 2COHORT 3COHORT 4Unassigned
Progression Free Survival11 (8.3 to 12.2)10.8 (7.3 to NA)7.2 (5.3 to 7.6)5.4 (3.7 to 5.6)9.2 (3.5 to 12.7)
SecondaryTime to Any Progression

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using time to any progression

Time frame:
From first dose to earlier date of CA-125 progression or RECIST v1.1 progression, or death by any cause in absence of progression (up to 36 months)
Reported as:
Median · Months
Time to Any Progression
MonthsCohort 1Cohort 2COHORT 3COHORT 4Unassigned
Time to Any Progression10.9 (7.4 to 13.3)11.1 (6.6 to NA)7.2 (3.8 to 7.6)5.3 (3.7 to 5.5)7.3 (3.5 to 9.7)
SecondaryOverall Survival

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using overall survival

Time frame:
From date of first dose to date of death from any cause (up to 48 months)
Reported as:
Median · Months
Overall Survival
MonthsCohort 1Cohort 2COHORT 3COHORT 4Unassigned
Overall SurvivalNA (29.2 to NA)NA (NA to NA)NA (22.8 to NA)23.8 (16.6 to 31.4)18 (8 to NA)
SecondaryHRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)

To determine the clinical effectiveness of olaparib treatment in each of 4 cohorts assessed using HRRm gene panel status related to clinical outcome

Time frame:
At baseline
Reported as:
Number · Percent
HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)
PercentCohort 3, HRRm PosCohort 3, HRRm NegCohort 4, HRRm PosCohort 4, HRRm Neg
HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)11.1 (0.3 to 48.2)32.1 (20.3 to 46.0)8.3 (0.2 to 38.5)10.5 (4.7 to 19.7)

Adverse events

Collected over Adverse events (AEs), serious AEs, AEs of special interest (AESIs), and AEs leading to discontinuation were collected from signature of informed consent for study participation. Treatment emerging AEs were reported from date of first dose of study treatment and continued throughout the active treatment period and the follow-up period 30 days after the last dose of olaparib. After the primary analysis data cut-off till study completion, only deaths, SAEs, AESIs and DAEs were collected/reported.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
COHORT 120/75 (26.7%)13/75 (17.3%)75/75 (100%)
COHORT 25/25 (20%)8/25 (32%)25/25 (100%)
COHORT 323/68 (33.8%)7/68 (10.3%)67/68 (98.5%)
COHORT 447/90 (52.2%)35/90 (38.9%)88/90 (97.8%)
UNASSIGNED7/13 (53.8%)6/13 (46.2%)12/13 (92.3%)
Most frequent serious events
Showing 10 of 63
Most frequent serious events
EventCOHORT 1COHORT 2COHORT 3COHORT 4UNASSIGNED
Small intestinal obstructionGastrointestinal disorders4/751/250/686/904/13
BacteraemiaInfections and infestations0/750/250/680/901/13
Strangulated incisional herniaInjury, poisoning and procedural complications0/750/250/680/901/13
DyspnoeaRespiratory, thoracic and mediastinal disorders0/750/250/680/901/13
PneumonitisRespiratory, thoracic and mediastinal disorders0/750/250/680/901/13
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/750/250/685/900/13
Intestinal obstructionGastrointestinal disorders1/750/251/684/900/13
Acute myocardial infarctionCardiac disorders0/751/250/680/900/13
Atrial fibrillationCardiac disorders0/751/250/680/900/13
Atrioventricular blockCardiac disorders0/751/250/680/900/13
Most frequent other events
Showing 10 of 347
Most frequent other events
EventCOHORT 1COHORT 2COHORT 3COHORT 4UNASSIGNED
NauseaGastrointestinal disorders50/7520/2542/6860/908/13
FatigueGeneral disorders50/7515/2543/6850/909/13
Abdominal painGastrointestinal disorders15/754/2510/6813/907/13
VomitingGastrointestinal disorders21/7512/2515/6835/906/13
AnaemiaBlood and lymphatic system disorders18/757/2514/6831/905/13
DiarrhoeaGastrointestinal disorders17/754/2515/6818/905/13
Decreased appetiteMetabolism and nutrition disorders11/756/2516/6821/905/13
Blood creatinine increasedInvestigations10/759/2513/6813/900/13
HeadacheNervous system disorders19/758/2513/6811/901/13
DyspepsiaGastrointestinal disorders7/753/259/6811/904/13

Baseline characteristics

Age, Continuous
Age, Continuous(Age Continuous)COHORT 1COHORT 2COHORT 3COHORT 4UnassignedTotal
Mean60.7 ± 9.369.7 ± 9.063.2 ± 9.967.8 ± 9.569.8 ± 10.064.9 ± 10.1
Sex/Gender, Customized
Sex/Gender, Customized(Participants)COHORT 1COHORT 2COHORT 3COHORT 4UnassignedTotal
Female7526689013272
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)COHORT 1COHORT 2COHORT 3COHORT 4UnassignedTotal
WHITE5823507811220
BLACK OR AFRICAN AMERICAN7055017
ASIAN63116228
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER000000
AMERICAN INDIAN OR ALASKA NATIVE001001
OTHER401106
08

Study locations

47 sites
  • Research Site
    Anchorage, Alaska 99508, United States
  • Research Site
    La Jolla, California 92093, United States
  • Research Site
    Los Angeles, California 90017, United States
  • Research Site
    Aurora, Colorado 80045, United States
  • Research Site
    Hartford, Connecticut 06102, United States
  • Research Site
    New Haven, Connecticut 06519, United States
  • Research Site
    Newark, Delaware 19718, United States
  • Research Site
    South Miami, Florida 33143, United States
  • Research Site
    Skokie, Illinois 60077, United States
  • Research Site
    Shreveport, Louisiana 71103, United States
  • Research Site
    Silver Spring, Maryland 20910, United States
  • Research Site
    Springfield, Massachusetts 01199, United States
  • Research Site
    Detroit, Michigan 48201, United States
  • Research Site
    Detroit, Michigan 48202, United States
  • Research Site
    Minneapolis, Minnesota 55407, United States
  • Research Site
    Saint Paul, Minnesota 55125, United States
  • Research Site
    Berkeley Heights, New Jersey 07922, United States
  • Research Site
    Hackensack, New Jersey 07601, United States
  • Research Site
    Newark, New Jersey 07103, United States
  • Research Site
    Teaneck, New Jersey 07666, United States
  • Research Site
    Bronx, New York 10461, United States
  • Research Site
    New York, New York 10021, United States
  • Research Site
    New York, New York 10032, United States
  • Research Site
    New York, New York 10065, United States
  • Research Site
    Winston-Salem, North Carolina 27103, United States
  • Research Site
    Cincinnati, Ohio 45219, United States
  • Research Site
    Portland, Oregon 97227, United States
  • Research Site
    Abington, Pennsylvania 19001, United States
  • Research Site
    Philadelphia, Pennsylvania 19104, United States
  • Research Site
    Pittsburgh, Pennsylvania 15224, United States
  • Research Site
    Providence, Rhode Island 02905, United States
  • Research Site
    Germantown, Tennessee 38138, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    Annandale, Virginia 22003, United States
  • Research Site
    Milwaukee, Wisconsin 53226, United States
  • Research Site
    Edmonton, Alberta T6G 1Z2, Canada
  • Research Site
    Vancouver, British Columbia VSZ 4E6, Canada
  • Research Site
    Winnipeg, Manitoba R3E 0V9, Canada
  • Research Site
    Halifax, Nova Scotia B3H 1V7, Canada
  • Research Site
    Hamilton, Ontario L8V 5C2, Canada
  • Research Site
    Kingston, Ontario K7L 2V7, Canada
  • Research Site
    Mississauga, Ontario L5M 2N1, Canada
  • Research Site
    Toronto, Ontario M4N 3M5, Canada
  • Research Site
    Montreal, Quebec H1T 2M4, Canada
  • Research Site
    Montreal, Quebec H2X 0A9, Canada
  • Research Site
    Montreal, Quebec H4A 3J1, Canada
  • Research Site
    Sherbrooke, Quebec J1H 5N4, Canada
09

References and documents

Study documents

  • Study protocol · Oct 10, 2017
  • Statistical analysis plan · Oct 3, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02983799
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 6, 2016
Start date
Dec 22, 2016
Primary completion
Dec 3, 2020
Completion
Dec 3, 2020
Results posted
Apr 13, 2022
Last update
Apr 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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