Advanced Solid TumoursPhase 1NCT02430311

The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

A Phase 1 study testing Olaparib and Paclitaxel in people with Advanced Solid Tumours, run by AstraZeneca at 3 sites in China.

Completed

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

Official record

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Trial summary

This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in combination with paclitaxel in patients with solid tumours. Part A will assess the single and multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of olaparib in combination with paclitaxel. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Advanced Solid Tumours
What is being tested?: Olaparib and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 3 sitesChina
Study dates: 10 Jun 2015to 28 Apr 2017
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 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of fully informed consent
Patient aged ≥ 18 years
Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists
life expectancy of ≥ 12 weeks
Patients for Cohort 2 must be eligible for paclitaxel treatment
Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations

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ECOG performance status ≤ 2
Satisfactory organ and bone marrow function measured within 28 days prior to administration of study treatment including - Haemoglobin ≥ 10.0 g/dL and no blood transfusion in the 4 weeks prior to the first dosing of study drug. - Absolute neutrophil count ≥ 1.5 × 109/L
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.
Patients must be on a stable concomitant medication regimen, 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

Involvement in the planning and/or conduct of the study.
Previous enrolment in the present study.
Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
Any previous treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor, including olaparib.
Patients with other malignancy within the last 5 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1, Grade 1 endometrial cancer, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.
Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. These include patients with gastric or intestinal cancer or patients with prior surgical procedures such as full or partial gastrectomy.

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Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study treatment.
Concomitant use of known potent CYP3A4 (Cytochrome P450 3A4) inhibitors.
Patients with any ongoing toxicities (>CTCAE (Common Terminology Criteria for Adverse Events) grade 2), with the exception of alopecia, caused by previous cancer therapy.
Resting ECG with QTc (Heart Rate Corrected QT interval) > 470msec or family history of long QT syndrome.
Patients with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
Patients with myelodysplastic syndrome/acute myeloid leukaemia.
Patients with symptomatic uncontrolled brain metastases.
Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
Patients with known active hepatic disease (i.e. Hepatitis B or C).
Patients with a known hypersensitivity to olaparib, paclitaxel or any of the excipients of the product.
Breastfeeding women.
Clinical judgement by the investigator that the patient should not participate in the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Research Site
Beijing, 100021
Research Site
Beijing, 100071
Research Site
Hangzhou, 310003

Other trials in China

About this study

Official title: A Phase I, Open Label, 2 Part Study to Determine the Pharmacokinetics of Olaparib 300 mg bd Administered as Monotherapy and Olaparib 100 mg bd as Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours

Read the detailed description

Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2 will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle).

In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in combination with weekly paclitaxel will also be investigated in Chinese patients.

Conditions: Advanced Solid Tumours
Being tested: Olaparib, Paclitaxel
Keywords: Chinese Patients

What participants receive

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

OlaparibDrug
Tablet-150mg, Oral
PaclitaxelDrug
Injection
OlaparibDrug
Tablet-100mg, Oral

Study groups in NCT02430311
Study group	Role	What they receive
Cohort 1	Experimental	Treat 15 patients, single dose olaparib 300mg followed by multiple dose olaparib 300mg twice a day Receives: Drug: Olaparib
Cohort 2	Experimental	Treat 15 patients, single dose olaparib 100mg followed by multiple dose olaparib 100 mg twice a day and then in combination with paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle) Receives: Drug: Paclitaxel; Drug: Olaparib

What is being measured

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

Single Dose PK Parameter--Cmax
Single dose PK parameter summary for olaparib in monotherapy by dose - Cmax (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single Dose PK Parameter--AUC
Single dose PK parameter summary for olaparib in monotherapy by dose - AUC (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single Dose PK Parameter--tmax
Single dose PK parameter summary for olaparib in monotherapy by dose - tmax (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single Dose PK Parameter--t1/2, λz
Single dose PK parameter summary for olaparib in monotherapy by dose - t1/2, λz (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single Dose PK Parameter--Vz/F
Single dose PK parameter summary for olaparib in monotherapy by dose - Vz/F (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single Dose PK Parameter--CL/F
Single dose PK parameter summary for olaparib in monotherapy by dose - CL/F (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady State PK Parameter--AUCss at Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady State PK Parameter--tmax, ss at Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady State PK Parameter--RAC and TCP at Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - RAC and TCP (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 9
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)
Measured: PK samples were collected pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9
Steady State PK Parameter--AUCss at Day 9
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9
Steady State PK Parameter--tmax, ss at Day 9
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9
Steady State PK Parameter--CLss/F at Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - CLss/F (PK analysis set)
Measured: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8

Timeline

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

10 Jun 201528 Apr 2017

First posted30 Apr 2015 (estimated)
Study start10 Jun 2015
Primary completion27 Jul 2016
Study completion28 Apr 2017

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 Advanced 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02430311
Sponsor's protocol ID: D081BC00002
Status last verified: Jul 2019
First submitted: 7 Apr 2015
Last updated: 31 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yuan P, Shentu J, Xu J, Burke W, Hsu K, Learoyd M, Zhu M, Xu B. Pharmacokinetics and safety of olaparib tablets as monotherapy and in combination with paclitaxel: results of a Phase I study in Chinese patients with advanced solid tumours. Cancer Chemother Pharmacol. 2019 May;83(5):963-974. doi: 10.1007/s00280-019-03799-1. Epub 2019 Mar 18.
PubMed 30887180

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

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All Advanced Solid Tumours trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label, 2 Part Study to Determine the Pharmacokinetics of Olaparib 300 mg bd Administered as Monotherapy and Olaparib 100 mg bd as Monotherapy and in Combination With Paclitaxel in Chinese Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT02430311
Acronym / sponsor ID: D081BC00002
Conditions: Advanced Solid Tumours
Keywords: Chinese Patients
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Jun 2015 (actual)
Primary completion: 27 Jul 2016 (actual)
Study completion: 28 Apr 2017 (actual)
First posted: 30 Apr 2015 (estimated)
Results: Posted 13 Sep 2018

Clinical summary

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

Detailed description

In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in combination with weekly paclitaxel will also be investigated in Chinese patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: OlaparibTreat 15 patients, single dose olaparib 300mg followed by multiple dose olaparib 300mg twice a day
Cohort 2	Experimental	Drug: Paclitaxel, Drug: OlaparibTreat 15 patients, single dose olaparib 100mg followed by multiple dose olaparib 100 mg twice a day and then in combination with paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle)

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Provision of fully informed consent
Patient aged ≥ 18 years
Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists
life expectancy of ≥ 12 weeks
Patients for Cohort 2 must be eligible for paclitaxel treatment

Key exclusion criteria (20 listed)

Involvement in the planning and/or conduct of the study.
Previous enrolment in the present study.
Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).
Any previous treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor, including olaparib.
Patients with other malignancy within the last 5 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1, Grade 1 endometrial cancer, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.

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
OlaparibTablet-150mg, Oral	Drug	Cohort 1
PaclitaxelInjection	Drug	Cohort 2
OlaparibTablet-100mg, Oral	Drug	Cohort 2

Primary outcome

Single Dose PK Parameter--Cmax
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single dose PK parameter summary for olaparib in monotherapy by dose - Cmax (PK analysis set)
Single Dose PK Parameter--AUC
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single dose PK parameter summary for olaparib in monotherapy by dose - AUC (PK analysis set)
Single Dose PK Parameter--tmax
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single dose PK parameter summary for olaparib in monotherapy by dose - tmax (PK analysis set)
Single Dose PK Parameter--t1/2, λz
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single dose PK parameter summary for olaparib in monotherapy by dose - t1/2, λz (PK analysis set)
Single Dose PK Parameter--Vz/F
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single dose PK parameter summary for olaparib in monotherapy by dose - Vz/F (PK analysis set)
Single Dose PK Parameter--CL/F
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)
Single dose PK parameter summary for olaparib in monotherapy by dose - CL/F (PK analysis set)
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 8
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)
Steady State PK Parameter--AUCss at Day 8
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)
Steady State PK Parameter--tmax, ss at Day 8
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)
Steady State PK Parameter--RAC and TCP at Day 8
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - RAC and TCP (PK analysis set)
Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 9
Time frame: PK samples were collected pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)
Steady State PK Parameter--AUCss at Day 9
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)
Steady State PK Parameter--tmax, ss at Day 9
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)
Steady State PK Parameter--CLss/F at Day 8
Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8
Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - CLss/F (PK analysis set)

Results and safety

Results posted to the registry on 13 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	20	19
Cohort 2	16	15

Primary outcome: Single Dose PK Parameter--Cmax

Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3). Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	Cohort 1 n = 16	Cohort 2 n = 15
Value	6.875 (39.70)	2.972 (41.80)

Population analysed: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.

Primary outcome: Single Dose PK Parameter--AUC

Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3). Geometric mean (Geometric Coefficient of Variation). Unit: µg*h/mL

Measure	Cohort 1 n = 16	Cohort 2 n = 15
AUC0-12	31.68 (52.97)	10.86 (61.60)
AUC0-t	36.37 (59.58)	12.63 (75.42)
AUC	36.53 (59.86)	12.75 (76.70)

Population analysed: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.

Primary outcome: Single Dose PK Parameter--tmax

Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3). Median (Full Range). Unit: hour

Measure	Cohort 2 n = 15	Cohort 1 n = 16
Value	1.95 (61.60)	1.50 (0.50 to 4.00)

Population analysed: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.

Primary outcome: Single Dose PK Parameter--t1/2, λz

Time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3). Mean (Standard Deviation). Unit: hour

Measure	Cohort 2 n = 15	Cohort 1 n = 16
Value	7.165 (2.542)	6.519 (1.346)

Population analysed: PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.

Adverse events

Time frame: Includes AEs with an onset date between the first dose date in the appropriate Part and the day before first dose in Part B (for Part A only), or 30 days following the date of last dose of study medication if the subject discontinued.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Part A	0 of 20 (0%)	11 of 20 (55%)	Not reported
Cohort 2 Part A, Olaparib 100 mg	0 of 16 (0%)	8 of 16 (50%)	Not reported
Cohort 2 Part A, Olaparib 100mg in Combination With Paclitaxel	4 of 16 (25%)	16 of 16 (100%)	Not reported
Cohort 1 Part B	0 of 19 (0%)	18 of 19 (94.7%)	Not reported
Cohort 2 Part B, Olaparib 300 mg Monotherapy	0 of 2 (0%)	2 of 2 (100%)	Not reported
Cohort 2 Part B, Olaparib 100mg in Combination With Paclitaxel	1 of 15 (6.7%)	15 of 15 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30887180Yuan P, Shentu J, Xu J, Burke W, Hsu K, Learoyd M, Zhu M, Xu B. Pharmacokinetics and safety of olaparib tablets as monotherapy and in combination with paclitaxel: results of a Phase I study in Chinese patients with advanced solid tumours. Cancer Chemother Pharmacol. 2019 May;83(5):963-974. doi: 10.1007/s00280-019-03799-1. Epub 2019 Mar 18.
Related InfoLink provided by the sponsor.

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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.

Binghe Xu, MD principal investigator

Cancer Institute and Hospital (CIH), Chinese Academy of Medical Sciences and Peking Union Medical College

Jianming Xu, MD principal investigator

307 Hospital of Military Medical Sciences

Jianzhong Shentu principal investigator

No.1 Affiliated Hospital of College of Medicine, Zhejiang University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olaparib and Paclitaxel in people with Advanced Solid Tumours, run by AstraZeneca at 3 sites in China.

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 10 inclusion and 20 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 13 Sep 2018). 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?

Single Dose PK Parameter--Cmax (time frame: PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)). The study lists 14 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 NCT02430311, 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 31 Jul 2019.