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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813474
• Other study ID #: D081BC00001
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2013
• Last updated: December 15, 2017
• Start date: March 25, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: December 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

MTD - maximum tolerated dose

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 130 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Cancer
• Neoplasms

Intervention

Drug:
• olaparib
tablet oral

Locations

Country	Name	City	State
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Sapporo-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From the start dose to 28 days after the first dose of study drug
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	AUC 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
Secondary	AUC at Steady State Following Multiple Dosing		Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose

External Links

•   D081BC00001_Study_Report_Synopsis