NCT02093351 is a Phase 1 clinical trial of Olaparib in Solid Tumours, sponsored by AstraZeneca.

Who is sponsoring NCT02093351?

NCT02093351 is sponsored by AstraZeneca.

What drugs are being tested in NCT02093351?

Interventions in NCT02093351: Olaparib, Tamoxifen, Anastrozole, Letrozole, Pharmacokinetic sampling.

What condition does NCT02093351 study?

NCT02093351 studies Solid Tumours.

Is NCT02093351 still recruiting?

NCT02093351 is currently completed. Last updated 2 October 2019.

Are results published for NCT02093351?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-02 · How we verify

NCT02093351

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Completed Phase 1 Results posted Last updated 2 October 2019

What this trial tests

Phase 1 trial testing Olaparib in Solid Tumours in 79 participants. Completed in 29 April 2019.

Timeline

1 September 2014

Primary endpoint
30 April 2015

29 April 2019

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	79
Start date	1 September 2014
Primary completion	30 April 2015
Estimated completion	29 April 2019
Sites	14 locations across Denmark, France, Netherlands, Belgium, United Kingdom

Drugs / interventions tested

Olaparib (olaparib) — full drug profile →
Tamoxifen
Anastrozole (anastrozole) — full drug profile →
Letrozole — full drug profile →
Pharmacokinetic sampling

Conditions studied

Solid Tumours — all drugs for Solid Tumours →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Solid Tumours. 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.

Effect of Olaparib on Exposure to Tamoxifen - Cmax ss Primary · Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31

Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios

PK analysis of tamoxifen

Group	Value	95% CI
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	130.3	± 27.3
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	154.2	± 34.9

PK analysis of N-DMT

Group	Value	95% CI
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	162.9	± 28.0
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	149.1	± 44.8

PK analysis of endoxifen

Group	Value	95% CI
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	5.923	± 65.7
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	5.727	± 61.2

Effect of Tamoxifen on Exposure to Olaparib - Cmax ss Primary · Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31

Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios

Group	Value	95% CI
Cohort 1 - Olaparib (Treatment Period 1)	9.456	± 41.5
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	7.216	± 43.6

Effect of Olaparib on Exposure to Anastrozole - Cmax ss Primary · Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24

Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios

Group	Value	95% CI
Cohort 2 - Anastrozole Alone (Treatment Period 2)	40.98	± 36.2
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	35.83	± 31.9

Effect of Anastrozole on Exposure to Olaparib - Cmax ss Primary · Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24

Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios

Group	Value	95% CI
Cohort 2 - Olaparib (Treatment Period 1)	9.490	± 34.3
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	8.256	± 39.9

Effect of Olaparib on Exposure to Letrozole - Cmax ss Primary · Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43

Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios

Group	Value	95% CI
Cohort 3 - Letrozole Alone (Treatment Period 2)	118.9	± 32.6
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	111.8	± 30.4

Effect of Letrozole on Exposure to Olaparib - Cmax ss Primary · Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43

Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios

Group	Value	95% CI
Cohort 3 - Olaparib (Treatment Period 1)	10.05	± 30.2
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	10.48	± 33.6

Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ Primary · Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31

Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios

PK analysis of tamoxifen

Group	Value	95% CI
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	2233	± 31.9
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	2751	± 28.9

PK analysis of N-DMT

Group	Value	95% CI
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	3189	± 28.8
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	2955	± 37.3

PK analysis of endoxifen

Group	Value	95% CI
Cohort 1 - Tamoxifen Alone (Treatment Period 2)	119.3	± 66.1
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	115.8	± 64.8

Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ Primary · Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31

Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios

Group	Value	95% CI
Cohort 1 - Olaparib (Treatment Period 1)	62.12	± 51.6
Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)	42.27	± 60.6

Effect of Olaparib on Exposure to Anastrozole - AUC0-τ Primary · Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24

Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios

Group	Value	95% CI
Cohort 2 - Anastrozole Alone (Treatment Period 2)	696.8	± 36.6
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	582.5	± 31.6

Effect of Anastrozole on Exposure to Olaparib - AUC0-τ Primary · Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24

Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios

Group	Value	95% CI
Cohort 2 - Olaparib (Treatment Period 1)	55.49	± 53.8
Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)	44.33	± 63.6

Effect of Olaparib on Exposure to Letrozole - AUC0-τ Primary · Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43

Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios

Group	Value	95% CI
Cohort 3 - Letrozole Alone (Treatment Period 2)	2292	± 36.7
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	2167	± 38.0

Effect of Letrozole on Exposure to Olaparib - AUC0-τ Primary · Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43

Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios

Group	Value	95% CI
Cohort 3 - Olaparib (Treatment Period 1)	61.77	± 43.2
Cohort 3 - Olaparib + Letrozole (Treatment Period 3)	67.82	± 44.1

Adverse events — posted to ClinicalTrials.gov

Time frame: For Part A, adverse events (AEs) were collected from the date of first dose up to last dose of study medication in Part A for patients continuing to Part B, or up to 30 days after last dose for patients who did not enter Part B (up to approximately 2 months). For Part B, AEs were collected from date of first dose in Part B up to 30 days after last dose (up to approximately 18 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 - Tamoxifen

Serious: 2/30 (7%)

Deaths: 1/30

Cohort 2 - Anastrozole

Serious: 0/23 (0%)

Deaths: 1/23

Cohort 3 - Letrozole

Serious: 0/26 (0%)

Deaths: 1/26

Olaparib (Part B)

Serious: 22/69 (32%)

Deaths: 1/69

Serious adverse events (22 terms)

Reaction	System	Cohort 1 - Tamoxifen	Cohort 2 - Anastrozole	Cohort 3 - Letrozole	Olaparib (Part B)
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Device Occlusion	General disorders	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Anaemia Macrocytic	Blood and lymphatic system disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Diplopia	Eye disorders	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—	—
Klebsiella Infection	Infections and infestations	—	—	—	—
Lower Respiratory Tract Infection	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Bladder Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cognitive Disorder	Nervous system disorders	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—
Superior Vena Cava Occlusion	Vascular disorders	—	—	—	—

Other adverse events (54 terms — click to expand)

Reaction	System	Cohort 1 - Tamoxifen	Cohort 2 - Anastrozole	Cohort 3 - Letrozole	Olaparib (Part B)
Fatigue	General disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Abdominal Distension	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Non-Cardiac Chest Pain	General disorders	—	—	—	—
Muscle Spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Lower Respiratory Tract Infection	Infections and infestations	—	—	—	—
Pain in Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Hot Flush	Vascular disorders	—	—	—	—
Abdominal Discomfort	Gastrointestinal disorders	—	—	—	—
Abdominal Pain Lower	Gastrointestinal disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—

Most-reported serious reactions: Anaemia, Device Occlusion, Urinary Tract Infection, Urosepsis, Constipation, Ascites, Vomiting, Anaemia Macrocytic.

Data from ClinicalTrials.gov NCT02093351 adverse events section.

Sponsor's own description

This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.

Publications & conference data

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

Trial watch - inhibiting PARP enzymes for anticancer therapy.
Sistigu A, Manic G, Obrist F, Vitale I. · · 2016 · cited 19× · PMID 27308587 · DOI 10.1080/23723556.2015.1053594
Pharmacokinetic Effects and Safety of Olaparib Administered with Endocrine Therapy: A Phase I Study in Patients with Advanced Solid Tumours.
Plummer R, Verheul HM, De Vos FYFL, Leunen K, et al · · 2018 · cited 13× · PMID 30324586 · DOI 10.1007/s12325-018-0804-z
Olaparib synergy screen reveals Exemestane induces replication stress in triple-negative breast cancer.
Yusoh NA, Su L, Chia SL, Tian X, et al · · 2025 · PMID 40652528 · DOI 10.1002/1878-0261.70093

Verify or expand the search:

Other trials of Olaparib

Trials testing the same drug.

NCT05522491 — Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Br · Phase 2 · not yet recruiting
NCT05128734 — Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) · Phase 2 · not yet recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07407452 — Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Che · Phase 2 · not yet recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting

Other recruiting trials for Solid Tumours

Currently open trials in the same condition.

NCT07391670 — A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durval · Phase 1 · recruiting
NCT07446855 — Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homo · Phase 1, PHASE2 · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07165067 — A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT07403370 — Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02093351 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 2 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02093351.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing