Solid TumoursPhase 1NCT01894256

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function

A Phase 1 study testing Olaparib tablet dosing in people with Solid Tumours, run by AstraZeneca at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumours
What is being tested?: Olaparib tablet dosing
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 13 sitesin 5 countries
Study dates: Nov 2013to Feb 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For inclusion in the study as a patient with renal impairment, the following criterion must be met:
Patients must have stable renal impairment (moderate or mild), depending on creatinine clearance estimated using the Cockcroft-Gault equation (moderate 31 to 50 mL/min; mild 51 to 80 mL/min), for at least 2 months prior to the start of the study. For inclusion in the study as a patient with normal renal function, the following criterion must be met:
Calculated serum creatinine clearance greater than or equal to 81 mL/min (using Cockcroft-Gault equation). All patients must fulfil the following criteria:
Provision of written informed consent prior to any study specific procedures .
Patients must be greater than or equal to 18 and less than or equal to 75 years of age.
Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy or for which no suitable effective standard therapy exists.

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BMI between 18-30 kg/m2.
Normal liver and bone marrow function measured within 28 days prior to administration of IP as defined below: Haemoglobin (Hb) greater than or equal to 10.0 g/dL, with no blood transfusions in the previous 28 days.
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L. White blood cells (WBC) greater than 3 x 109/L. Platelet count greater than or equal to 100 x 109/L. Total bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN) (except in the case of Gilbert's disease).
Aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST), alanine aminotransferase or serum glutamic pyruvic transaminase (ALT) less than or equal to 2.5 x institutional ULN unless liver metastases are present in which case it must be less than or equal to 5x ULN.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
Patients must have a life expectancy greater than or equal to 12 weeks.
Evidence of non childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on Day 1 of the first treatment period in Part A. Postmenopausal is defined as:
Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments.
Luteinising hormone and follicle-stimulating hormone levels in the postmenopausal range for women under 50 years of age.
Radiation-induced oophorectomy with last menses greater than 1 year ago. Chemotherapy-induced menopause with greater than 1 year interval since last menses Surgical sterilisation (bilateral oophorectomy or hysterectomy).
Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Patients must be on a stable concomitant medication regimen (with the exception of electrolyte supplements), defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.

Who cannot join

Patients must not enter the study if any of the following exclusion criteria are fulfilled:
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, its agents and/or staff at the study site).
Previous enrolment in the present study.
Participation in another clinical study with an investigational medicinal product (IP) during the last 14 days (or a longer period depending on the defined characteristics of the agent used).
Renal transplant and end stage renal disease (ESRD) patients.
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 2 weeks prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases before and during the study as long as these were started at least 4 weeks prior to treatment.

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Patients who have received or are receiving inhibitors or inducers of CYP3A4 within the washout period.
For Part A only, drugs which affect creatinine clearance such as cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine and quinine should not be used within the 7 days prior to dosing with olaparib.
Treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (eg, halothane).
Persistent toxicities (greater than or equal to CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia.
Patients with myelodysplastic syndrome/acute myeloid leukaemia.
Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with asymptomatic brain metastases or with symptomatic but stable brain metastases can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of major surgery.
Patients considered a poor medical risk due to a serious uncontrolled medical disorder, non malignant systemic disease, uncontrolled seizures, or active uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive bilateral interstitial lung disease on high resolution computer tomography (HRCT) scan, or any psychiatric disorder that prohibits obtaining informed consent.
Patients with a history of heart failure or left ventricular dysfunction.
Patients who have gastric, gastro-oesophageal or oesophageal cancer.
Patients unable to swallow orally administered medication and patients with gastrointestinal disorders or significant gastrointestinal resection likely to interfere with the absorption of olaparib.
Breastfeeding women.
Immunocompromised patients eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
Patients with known active hepatic disease (eg, hepatitis B or C).
Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
Resting ECG at screening with measurable QTc greater than 470 msec at 2 or more time points within a 24 hour period or family history of long QT syndrome.
Clinical judgment by the investigator that the patient should not participate in the study.

Trial locations and contacts

13 sites in 5 countries.

Country

City, postcode or hospital

13 sites in 5 countries

Belgium5 sites

Research Site
Brussels (Jette)
Research Site
Edegem
Research Site
Leuven
Research Site
Liège
Research Site
Wilrijk

Other trials in Belgium

Denmark2 sites

Research Site
Herlev
Research Site
København Ø

Other trials in Denmark

France2 sites

Research Site
Bordeaux
Research Site
Dijon

Other trials in France

Netherlands2 sites

Research Site
Amsterdam
Research Site
Maastricht

Other trials in Netherlands

United Kingdom2 sites

Research Site
Newcastle upon Tyne
Research Site
Surrey

Other trials in United Kingdom

About this study

Official title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment

Conditions: Solid Tumours
Being tested: Olaparib tablet dosing
Keywords: oncology,, cancer,, neoplasm,, anticancer drug,, pharmacokinetics,, area under curve,, olaparib,, solid tumour,, mild renal impairment,, moderate renal impairment
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olaparib tablet dosingDrug
Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd

Study groups in NCT01894256
Study group	Role	What they receive
Normal renal function	Other	Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Receives: Drug: Olaparib tablet dosing
Mild renal impairment	Other	Patients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation). Receives: Drug: Olaparib tablet dosing
Moderate renal impairment	Other	Patients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation). Receives: Drug: Olaparib tablet dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Olaparib
Maximum plasma drug concentration of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
AUC of Olaparib
Area under plasma concentration-time curve from zero to infinity of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
AUC0-t of Olaparib
Area under plasma concentration-time curve from zero to the last measurable time point of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Tmax of Olaparib
Time to reach maximum plasma concentration of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Vz/F of Olaparib
Apparent volume of distribution of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
CL/F of Olaparib
Apparent plasma clearance of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
CLR of Olaparib
Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24
Measured: Part A: Day 1, 0-12 hours and 12-24 hours post-dose
t1/2 of Olaparib
Terminal half-life of olaparib
Measured: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Feb 2016

First posted10 Jul 2013 (estimated)
Study startNov 2013
Primary completionMar 2015
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumoursStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01894256
Sponsor's protocol ID: D0816C00006
Other IDs: 2013-002225-30
Status last verified: Aug 2016
First submitted: 4 Jul 2013
Last updated: 13 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rolfo C, de Vos-Geelen J, Isambert N, Molife LR, Schellens JHM, De Greve J, Dirix L, Grundtvig-Sorensen P, Jerusalem G, Leunen K, Mau-Sorensen M, Plummer R, Learoyd M, Bannister W, Fielding A, Ravaud A. Pharmacokinetics and Safety of Olaparib in Patients with Advanced Solid Tumours and Renal Impairment. Clin Pharmacokinet. 2019 Sep;58(9):1165-1174. doi: 10.1007/s40262-019-00754-4.
PubMed 30877569

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumours trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment
ClinicalTrials.gov ID: NCT01894256
Acronym / sponsor ID: D0816C00006
Conditions: Solid Tumours
Keywords: oncology,, cancer,, neoplasm,, anticancer drug,, pharmacokinetics,, area under curve,, olaparib,, solid tumour,
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Mar 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 10 Jul 2013 (estimated)
Results: Posted 19 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Normal renal function	Other	Drug: Olaparib tablet dosingPatients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation).
Mild renal impairment	Other	Drug: Olaparib tablet dosingPatients with calculated serum creatinine clearance 51-80 mL/min (using Cockcroft-Gault equation).
Moderate renal impairment	Other	Drug: Olaparib tablet dosingPatients with calculated serum creatinine clearance 31-50 mL/min (using Cockcroft-Gault equation).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

For inclusion in the study as a patient with renal impairment, the following criterion must be met:
Patients must have stable renal impairment (moderate or mild), depending on creatinine clearance estimated using the Cockcroft-Gault equation (moderate 31 to 50 mL/min; mild 51 to 80 mL/min), for at least 2 months prior to the start of the study. For inclusion in the study as a patient with normal renal function, the following criterion must be met:
Calculated serum creatinine clearance greater than or equal to 81 mL/min (using Cockcroft-Gault equation). All patients must fulfil the following criteria:
Provision of written informed consent prior to any study specific procedures .
Patients must be greater than or equal to 18 and less than or equal to 75 years of age.

Key exclusion criteria (23 listed)

Patients must not enter the study if any of the following exclusion criteria are fulfilled:
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, its agents and/or staff at the study site).
Previous enrolment in the present study.
Participation in another clinical study with an investigational medicinal product (IP) during the last 14 days (or a longer period depending on the defined characteristics of the agent used).
Renal transplant and end stage renal disease (ESRD) patients.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olaparib tablet dosingPart A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd	Drug	Mild renal impairment, Moderate renal impairment, Normal renal function

Primary outcome

Cmax of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Maximum plasma drug concentration of olaparib
AUC of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Area under plasma concentration-time curve from zero to infinity of olaparib
AUC0-t of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Area under plasma concentration-time curve from zero to the last measurable time point of olaparib
Tmax of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Time to reach maximum plasma concentration of olaparib
Vz/F of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Apparent volume of distribution of olaparib
CL/F of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Apparent plasma clearance of olaparib
CLR of Olaparib
Time frame: Part A: Day 1, 0-12 hours and 12-24 hours post-dose
Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24
t1/2 of Olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Terminal half-life of olaparib

Results and safety

Results posted to the registry on 19 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Renal Function	15	15
Mild Renal Impairment	15	14
Moderate Renal Impairment	14	14

Primary outcome: Cmax of Olaparib

Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: μg/mL

Measure	Normal Renal Function n = 12	Mild Renal Impairment n = 13	Moderate Renal Impairment n = 13
Value	7.227 (31.0)	9.081 (40.6)	9.977 (44.2)

Normal Renal Function vs Mild Renal Impairment: Geometric least squares means ratio: 1.15 (90% CI 1.04 to 1.27)
Normal Renal Function vs Moderate Renal Impairment: Geometric least squares means ratio: 1.26 (90% CI 1.06 to 1.48)

Population analysed: PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose. Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded.

Primary outcome: AUC of Olaparib

Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: μg*h/mL

Measure	Normal Renal Function n = 12	Mild Renal Impairment n = 13	Moderate Renal Impairment n = 13
Value	43.70 (50.1)	70.56 (75.6)	76.44 (78.2)

Normal Renal Function vs Mild Renal Impairment: Geometric least squares means ratio: 1.24 (90% CI 1.06 to 1.47)
Normal Renal Function vs Moderate Renal Impairment: Geometric least squares means ratio: 1.44 (90% CI 1.10 to 1.89)

Primary outcome: AUC0-t of Olaparib

Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: μg*h/mL

Measure	Normal Renal Function n = 12	Mild Renal Impairment n = 13	Moderate Renal Impairment n = 13
Value	39.97 (48.3)	62.80 (70.3)	69.19 (71.6)

Primary outcome: Tmax of Olaparib

Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose. Median (Full Range). Unit: Hours

Measure	Normal Renal Function n = 12	Mild Renal Impairment n = 13	Moderate Renal Impairment n = 13
Value	1.99 (1.07 to 3.03)	1.55 (1.00 to 3.00)	2.00 (1.00 to 3.00)

Adverse events

Time frame: AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Normal Renal Function	0 of 15 (0%)	10 of 15 (66.7%)	Not reported
Part A Mild Renal Impairment	1 of 15 (6.7%)	11 of 15 (73.3%)	Not reported
Part A Moderate Renal Impairment	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
Part B Normal Renal Function	3 of 15 (20%)	15 of 15 (100%)	Not reported
Part B Mild Renal Impairment	3 of 14 (21.4%)	14 of 14 (100%)	Not reported
Part B Moderate Renal Impairment	3 of 14 (21.4%)	14 of 14 (100%)	Not reported

Limitations and caveats (from the sponsor): Data are presented for Part A and Part B.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30877569Rolfo C, de Vos-Geelen J, Isambert N, Molife LR, Schellens JHM, De Greve J, Dirix L, Grundtvig-Sorensen P, Jerusalem G, Leunen K, Mau-Sorensen M, Plummer R, Learoyd M, Bannister W, Fielding A, Ravaud A. Pharmacokinetics and Safety of Olaparib in Patients with Advanced Solid Tumours and Renal Impairment. Clin Pharmacokinet. 2019 Sep;58(9):1165-1174. doi: 10.1007/s40262-019-00754-4.

Related trials for Solid Tumours

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anitra Fielding study director

AstraZeneca Senior Research Physician

Christian Rolfo principal investigator

UZ Antwerpen

13 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olaparib tablet dosing in people with Solid Tumours, run by AstraZeneca at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium, Denmark, France, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of Olaparib (time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01894256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.