A Phase 2 interventional study of olaparib and paclitaxel in Ovarian Cancer, sponsored by AstraZeneca. Active, not recruiting at 53 sites in 13 countries. Open to female participants aged 18 Years to 125 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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Among 69 studies testing olaparib in Ovarian Neoplasms — 13 open to participants now, 26 under way, 9 of them phase 3. olaparib · Ovarian Neoplasms.
Among the 69 studies testing olaparib in Ovarian Neoplasms, this one is the 27th largest by enrollment, is the only one that started in 2010, is one of 32 in phase 2, reaches primary completion later than 0 of the 25 other live ones, and was the 7th registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →13 of the 69 studies testing olaparib in Ovarian Neoplasms are open now, in 8 countries. Recruiting first, the newest first:
Bai-Rong Xia · Sites in China
Ages 18–75 · Women only
Daewoong Pharmaceutical Co. LTD. · Sites in Korea, Republic of
Ages 19+ · Women only
Boryung Pharmaceutical Co., Ltd · Sites in Korea, Republic of
Ages 19–74 · Women only
The Netherlands Cancer Institute · Sites in Netherlands
Ages 18–100 · Women only
NRG Oncology · Sites in United States, Japan, Puerto Rico
Ages 18+
By country, each count listing its studies:
olaparib: first FDA approval 2014 (LYNPARZA), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years to 125 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, olaparib is the treatment under test here. Read study by study →
69 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 35 · Phase 3 17 · Phase 4 3
First in 2005; this study’s year is marked. 1 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 162 is above the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 97 across the 69 interventional studies. Of the 32 that completed or were terminated, 15 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 69 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
70 studies in Ovarian Neoplasms by AstraZeneca: 8 open now, 20 under way, 6 of them phase 3. Of 45 finished, 14 (31%) have results posted.
Among the 70 studies in Ovarian Neoplasms by AstraZeneca, this one is the 25th largest by enrollment of the 47 interventional ones that give a count, is one of 3 that started in 2010, is one of 12 in phase 2, reaches primary completion later than 0 of the 19 other live ones, and was the 10th registered.
AstraZeneca’s Ovarian Neoplasms studies by the year they started, since 2001.
5 of the studies testing olaparib in Ovarian Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT03579316M.D. Anderson Cancer CenterAdavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | 2026-12-31 |
| NCT07371104Daewoong Pharmaceutical Co. LTD.Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer | 2027-03 |
| NCT07460180The Netherlands Cancer InstituteThe PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer | 2027-05-01 |
| NCT03943173M.D. Anderson Cancer CenterOlaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery | 2027-06-27 |
Add all 5 to your calendar (.ics) → With an account.
Among the 69 studies testing olaparib in Ovarian Neoplasms, from their registry updates:
Among AstraZeneca’s 70 in Ovarian Neoplasms:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.
Drug: olaparib · Drug: paclitaxel · Drug: Drug: carboplatin
paclitaxel iv and carboplatin iv
Drug: paclitaxel · Drug: carboplatin
Tablets Oral BID
Also known as: Lynparza
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
Also known as: Taxol
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
175mg/m2 iv for up to 6 cycles (18 weeks)
AUC4 iv for up to 6 cycles (18 weeks)
Progression Free Survival (PFS)
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).
Time frame: 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)
Overall Survival (OS)
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)
Time frame: Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)
Percentage Change in Tumour Size
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.
Time frame: Week 9 (+/- 1 week)
The first patient was enrolled on 12-Feb-2010. The last patient was enrolled on 15-Jul-2010. Patients were enrolled at 43 sites in 12 countries: Australia, Belgium, Canada, Czech Republic, Germany, Italy, Japan, the Netherlands, Panama, Spain, the UK and the USA. 173 patients were screened and 162 patients were enrolled to receive treatment.
| Milestone | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
| Started | 81 | 81 |
| Received study treatment | 81 | 75 |
| Entered maintenance phase | 66 | 55 |
| Ongoing study treatment at data cut-off | 11 | 0 |
| Completed | 25 | 26 |
| Not completed | 56 | 55 |
| Withdrew: Death | 54 | 47 |
| Withdrew: Withdrawal by subject | 2 | 6 |
| Withdrew: Allocated treatment but did not take it | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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).
| months | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
| Progression Free Survival (PFS) | 12.2 (9.7 to 15.0) | 9.6 (9.1 to 9.7) |
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)
| Participants (Number of deaths) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
| Overall Survival (OS) | 54 | 47 |
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.
| Percentage change | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
| Percentage Change in Tumour Size | -38.4 ± 4.0 | -39.1 ± 4.0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olaparib/Carboplatin AUC4/Paclitaxel | 54/81 (66.7%) | 17/81 (21%) | 81/81 (100%) |
| Carboplatin AUC6/Paclitaxel | 47/81 (58%) | 19/75 (25.3%) | 72/75 (96%) |
| Event | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 3/81 | 1/75 |
| NeutropeniaBlood and lymphatic system disorders | 3/81 | 1/75 |
| AnaemiaBlood and lymphatic system disorders | 0/81 | 2/75 |
| Abdominal PainGastrointestinal disorders | 0/81 | 2/75 |
| Drug HypersensitivityImmune system disorders | 2/81 | 2/75 |
| Femoral Neck FractureInjury, poisoning and procedural complications | 2/81 | 0/75 |
| LymphadenitisBlood and lymphatic system disorders | 0/81 | 1/75 |
| Angina UnstableCardiac disorders | 0/81 | 1/75 |
| EntropionEye disorders | 0/81 | 1/75 |
| Eyelid PtosisEye disorders | 0/81 | 1/75 |
| Event | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel |
|---|---|---|
| NauseaGastrointestinal disorders | 65/81 | 44/75 |
| AlopeciaSkin and subcutaneous tissue disorders | 60/81 | 44/75 |
| FatigueGeneral disorders | 52/81 | 43/75 |
| NeutropeniaBlood and lymphatic system disorders | 41/81 | 32/75 |
| DiarrhoeaGastrointestinal disorders | 37/81 | 24/75 |
| VomitingGastrointestinal disorders | 33/81 | 21/75 |
| HeadacheNervous system disorders | 32/81 | 8/75 |
| ConstipationGastrointestinal disorders | 30/81 | 24/75 |
| Decreased AppetiteMetabolism and nutrition disorders | 27/81 | 19/75 |
| MyalgiaMusculoskeletal and connective tissue disorders | 27/81 | 18/75 |
| Age, Continuous(years) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total |
|---|---|---|---|
| Mean | 57.9 ± 10.0 | 59.0 ± 10.7 | 58.5 ± 10.3 |
| Age, Customized(Participants) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total |
|---|---|---|---|
| < 50 | 15 | 17 | 32 |
| ≥ 50 - < 65 | 45 | 40 | 85 |
| ≥ 65 | 21 | 24 | 45 |
| Sex: Female, Male(Participants) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total |
|---|---|---|---|
| Female | 81 | 81 | 162 |
| Male | 0 | 0 | 0 |
| Number of prior platinum-containing treatment lines(Participants) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total |
|---|---|---|---|
| 1 | 58 | 53 | 111 |
| >1 | 23 | 28 | 51 |
| Time to disease progression on completion of the previous platinum therapy(Participants) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total |
|---|---|---|---|
| PD > 6 to ≤ 12 months after completion | 39 | 40 | 79 |
| PD >12 months after completion | 42 | 41 | 83 |
| Classification of BRCA status(Participants) | Olaparib/Carboplatin AUC4/Paclitaxel | Carboplatin AUC6/Paclitaxel | Total |
|---|---|---|---|
| BRCAm | 20 | 21 | 41 |
| BRCAwt | 30 | 29 | 59 |
| BRCA VUS | 4 | 3 | 7 |
| BRCA missing | 27 | 28 | 55 |
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, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Feb 2010 to primary completion in Oct 2011, 20 months.
Results were first posted in Dec 2012, 1 year 2 months after primary completion.
Of 116 industry-sponsored phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's 20 months is below that.
Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Olaparib · Carboplatin