NCT01813474

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Mar 2013

Typical duration for phase_1 cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

March 25, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 12, 2017

Completed
Last Updated

January 16, 2018

Status Verified

December 1, 2017

Enrollment Period

3.4 years

First QC Date

March 15, 2013

Results QC Date

July 6, 2017

Last Update Submit

December 15, 2017

Conditions

CancerAdvanced Solid Malignancies

Keywords

CancerTumourSolid Malignancies

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the start dose to 30 days after the last dose of study drug

Secondary Outcomes (7)

  • Number of Participants With Dose Limiting Toxicities

    From the start dose to 28 days after the first dose of study drug

  • Cmax Following Single Dosing

    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

    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

    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

    Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

  • +2 more secondary outcomes

Study Arms (1)

olaparib tablet monotherapy

EXPERIMENTAL

olaparib tablet

Drug: olaparib

Interventions

olaparibDRUG

tablet oral

olaparib tablet monotherapy

Eligibility Criteria

Age20 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Chūōku, 104-0045, Japan

Location

Research Site

Fukuoka, 811-1395, Japan

Location

Research Site

Sapporo, 003-0804, Japan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

olaparib

Results Point of Contact

Title
Medical Director
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Thomas Morris, M.D.

    Global Medicines Development

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2013

First Posted

March 19, 2013

Study Start

March 25, 2013

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

January 16, 2018

Results First Posted

December 12, 2017

Record last verified: 2017-12

Locations

JP(3)