CancerPhase 1NCT01813474

Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

A Phase 1 study testing olaparib in people with Cancer and Advanced Solid Malignancies, run by AstraZeneca at 3 sites in Japan.

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

The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated. Read more about this study

Who is it for?: Ages 20 to 130 years
Conditions the study is for: Cancer, Advanced Solid Malignancies
What is being tested?: olaparib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 3 sitesJapan
Study dates: 25 Mar 2013to 31 Aug 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 20 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
Subjects who have overall good overall general condition.
Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15.
Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits

Who cannot join

Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib.
Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).
Subjects with symptomatic uncontrolled brain metastases.
Subjects with myelodysplastic syndrome/acute myeloid leukaemia.
Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 811-1395
Research Site
Sapporo, 003-0804

Other trials in Japan

About this study

Official title: A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

Read the detailed description

MTD - maximum tolerated dose

Conditions: Cancer, Advanced Solid Malignancies
Being tested: olaparib
Keywords: Cancer, Tumour, Solid Malignancies
Medical subject headings: Neoplasms

What participants receive

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

olaparibDrug
tablet oral

Study groups in NCT01813474
Study group	Role	What they receive
olaparib tablet monotherapy	Experimental	olaparib tablet Receives: Drug: olaparib

What is being measured

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

Number of Participants With Adverse Events
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.
Measured: From the start dose to 30 days after the last dose of study drug

Secondary outcomes (7)

Number of Participants With Dose Limiting Toxicities
Dose Limiting Toxicities were defined as study specific events that is determined to be possibly or probably related to olaparib (as determined by the investigator) and occurring during the first cycle of treatment (28 days after the first dose), irrespective of whether the toxicity resolved.
Measured: From the start dose to 28 days after the first dose of study drug
Cmax Following Single Dosing
Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Cmax Following Multiple Dosing
Measured: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
Tmax Following Single Dosing
Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Tmax Following Multiple Dosing
Measured: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
AUC Following Single Dosing
Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
AUC at Steady State Following Multiple Dosing
Measured: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

Timeline

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

25 Mar 201331 Aug 2016

First posted19 Mar 2013 (estimated)
Study start25 Mar 2013
Primary completion31 Aug 2016
Study completion31 Aug 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.
Other trials for CancerStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01813474
Sponsor's protocol ID: D081BC00001
Status last verified: Dec 2017
First submitted: 15 Mar 2013
Last updated: 16 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT01813474
Acronym / sponsor ID: D081BC00001
Conditions: Cancer, Advanced Solid Malignancies
Keywords: Cancer, Tumour, Solid Malignancies
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 25 Mar 2013 (actual)
Primary completion: 31 Aug 2016 (actual)
Study completion: 31 Aug 2016 (actual)
First posted: 19 Mar 2013 (estimated)
Results: Posted 12 Dec 2017

Clinical summary

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

Detailed description

MTD - maximum tolerated dose

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
olaparib tablet monotherapy	Experimental	Drug: olaparibolaparib tablet

Who may qualify

Ages: 20 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
Subjects who have overall good overall general condition.
Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15.
Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits

Key exclusion criteria (5 listed)

Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib.
Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).
Subjects with symptomatic uncontrolled brain metastases.
Subjects with myelodysplastic syndrome/acute myeloid leukaemia.
Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.

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 oral	Drug	olaparib tablet monotherapy

Primary outcome

Number of Participants With Adverse Events
Time frame: From the start dose to 30 days after the last dose of study drug
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.

7 secondary outcomes

Number of Participants With Dose Limiting Toxicities
Time frame: From the start dose to 28 days after the first dose of study drug
Cmax Following Single Dosing
Time frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Cmax Following Multiple Dosing
Time frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
Tmax Following Single Dosing
Time frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Tmax Following Multiple Dosing
Time frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
AUC Following Single Dosing
Time frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
AUC at Steady State Following Multiple Dosing
Time frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

Results and safety

Results posted to the registry on 12 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
200 mg Bid, Dose Escalation Part	4	1
300 mg Bid, Dose Escalation Part	7	0
300 mg Bid, Expansion Part	12	1

Primary outcome: Number of Participants With Adverse Events

Time frame: From the start dose to 30 days after the last dose of study drug. Number. Unit: Participants

Measure	200 mg Bid, Dose Escalation Part n = 4	300 mg Bid, Dose Escalation Part n = 7	300 mg Bid, Expansion Part n = 12
At least 1 Adverse Events (AE)	4	7	10
At least 1 AE of CTCAE Grade 3 or higher	1	3	1
At least 1 Serious Adverse Events (SAE)	1	0	0

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through treatment and 30-day follow-up period, an average of about 4 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
200 mg Bid, Dose Escalation Part	1 of 4 (25%)	4 of 4 (100%)	Not reported
300 mg Bid, Dose Escalation Part	0 of 7 (0%)	7 of 7 (100%)	Not reported
300 mg Bid, Expansion Part	0 of 12 (0%)	10 of 12 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D081BC00001\_Study\_Report\_SynopsisLink provided by the sponsor.

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RecruitingPhase 2
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Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
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Enrolling by invitationPhase 2
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Pancreatic Cancer Metastatic
Recruiting
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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.

Thomas Morris, M.D. study director

Global Medicines Development

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 in people with Cancer and Advanced Solid Malignancies, run by AstraZeneca at 3 sites in Japan.

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 5 inclusion and 5 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 16 Jan 2018. 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 Japan. 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 12 Dec 2017). 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?

Number of Participants With Adverse Events (time frame: From the start dose to 30 days after the last dose of study drug). 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 NCT01813474.

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 16 Jan 2018.