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NCT01081951

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Active, enrolled Phase 2 Results posted Last updated 5 February 2026
What this trial tests

Phase 2 trial testing olaparib in Ovarian Cancer in 162 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
4 February 2010
Primary endpoint
10 October 2011
31 December 2026

Quick facts

Lead sponsorAstraZeneca
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment162
Start date4 February 2010
Primary completion10 October 2011
Estimated completion31 December 2026
Sites53 locations across Italy, Panama, Japan, Netherlands, Peru, Belgium, United Kingdom, Germany

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 125, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) Primary · Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)

PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).

GroupValue95% CI
Olaparib/Carboplatin AUC4/Paclitaxel12.29.7 – 15.0
Carboplatin AUC6/Paclitaxel9.69.1 – 9.7
Overall Survival (OS) Secondary · Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)

OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. Updated OS based on final OS analysis (DCO 31 January 2014)

GroupValue95% CI
Olaparib/Carboplatin AUC4/Paclitaxel54
Carboplatin AUC6/Paclitaxel47
Percentage Change in Tumour Size Secondary · Week 9 (+/- 1 week)

The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as \[(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions\]\*100 for each patient. Imputations were used for missing data where possible.

GroupValue95% CI
Olaparib/Carboplatin AUC4/Paclitaxel-38.4± 4.0
Carboplatin AUC6/Paclitaxel-39.1± 4.0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Olaparib/Carboplatin AUC4/Paclitaxel
Serious: 17/81 (21%)
Deaths: 54/81
Carboplatin AUC6/Paclitaxel
Serious: 19/75 (25%)
Deaths: 47/81

Serious adverse events (31 terms)

ReactionSystemOlaparib/Carboplatin AUC4/…Carboplatin AUC6/Paclitaxel
Febrile NeutropeniaBlood and lymphatic system disorders
NeutropeniaBlood and lymphatic system disorders
AnaemiaBlood and lymphatic system disorders
Abdominal PainGastrointestinal disorders
Drug HypersensitivityImmune system disorders
Femoral Neck FractureInjury, poisoning and procedural complications
LymphadenitisBlood and lymphatic system disorders
Angina UnstableCardiac disorders
EntropionEye disorders
Eyelid PtosisEye disorders
Abdominal Pain UpperGastrointestinal disorders
Gastrointestinal ObstructionGastrointestinal disorders
Gastrointestinal PainGastrointestinal disorders
Small Intestinal ObstructionGastrointestinal disorders
VomitingGastrointestinal disorders
PyrexiaGeneral disorders
Hepatitis AcuteHepatobiliary disorders
Anaphylactic ReactionImmune system disorders
Anaphylactic ShockImmune system disorders
Cytomegalovirus InfectionInfections and infestations
Enterocolitis InfectiousInfections and infestations
Muscle AbscessInfections and infestations
Urinary Tract InfectionInfections and infestations
Cervical Vertebral FractureInjury, poisoning and procedural complications
Coagulation Time ProlongedInvestigations
Other adverse events (60 terms — click to expand)

ReactionSystemOlaparib/Carboplatin AUC4/…Carboplatin AUC6/Paclitaxel
NauseaGastrointestinal disorders
AlopeciaSkin and subcutaneous tissue disorders
FatigueGeneral disorders
NeutropeniaBlood and lymphatic system disorders
DiarrhoeaGastrointestinal disorders
VomitingGastrointestinal disorders
HeadacheNervous system disorders
ConstipationGastrointestinal disorders
Decreased AppetiteMetabolism and nutrition disorders
MyalgiaMusculoskeletal and connective tissue disorders
Neuropathy PeripheralNervous system disorders
AnaemiaBlood and lymphatic system disorders
Abdominal PainGastrointestinal disorders
DyspepsiaGastrointestinal disorders
ArthralgiaMusculoskeletal and connective tissue disorders
DysgeusiaNervous system disorders
Peripheral Sensory NeuropathyNervous system disorders
ThrombocytopeniaBlood and lymphatic system disorders
CoughRespiratory, thoracic and mediastinal disorders
InsomniaPsychiatric disorders
StomatitisGastrointestinal disorders
Abdominal Pain UpperGastrointestinal disorders
NasopharyngitisInfections and infestations
DizzinessNervous system disorders
Drug HypersensitivityImmune system disorders
Pain In ExtremityMusculoskeletal and connective tissue disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
RashSkin and subcutaneous tissue disorders
AstheniaGeneral disorders
LeukopeniaBlood and lymphatic system disorders
Back PainMusculoskeletal and connective tissue disorders
ParaesthesiaNervous system disorders
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders
PyrexiaGeneral disorders
PruritusSkin and subcutaneous tissue disorders
Oedema PeripheralGeneral disorders
Muscle SpasmsMusculoskeletal and connective tissue disorders
Musculoskeletal PainMusculoskeletal and connective tissue disorders
HypomagnesaemiaMetabolism and nutrition disorders
Bone PainMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Febrile Neutropenia, Neutropenia, Anaemia, Abdominal Pain, Drug Hypersensitivity, Femoral Neck Fracture, Lymphadenitis, Angina Unstable.

Data from ClinicalTrials.gov NCT01081951 adverse events section.

Sponsor's own description

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ovarian cancer.
    Matulonis UA, Sood AK, Fallowfield L, Howitt BE, et al · · 2016 · cited 954× · PMID 27558151 · DOI 10.1038/nrdp.2016.61
  2. Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer.
    Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D'Andrea AD. · · 2015 · cited 733× · PMID 26463832 · DOI 10.1158/2159-8290.cd-15-0714
  3. Advances in ovarian cancer therapy.
    Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. · · 2018 · cited 417× · PMID 29249039 · DOI 10.1007/s00280-017-3501-8
  4. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial.
    Oza AM, Cibula D, Benzaquen AO, Poole C, et al · · 2015 · cited 410× · PMID 25481791 · DOI 10.1016/s1470-2045(14)71135-0
  5. Targeting DNA damage response in cancer therapy.
    Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
  6. PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions.
    Konecny GE, Kristeleit RS. · · 2016 · cited 155× · PMID 27736844 · DOI 10.1038/bjc.2016.311
  7. Long-Term Responders on Olaparib Maintenance in High-Grade Serous Ovarian Cancer: Clinical and Molecular Characterization.
    Lheureux S, Lai Z, Dougherty BA, Runswick S, et al · · 2017 · cited 117× · PMID 28223274 · DOI 10.1158/1078-0432.ccr-16-2615
  8. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
    Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6

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