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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Investigate the safety and tolerability of olaparib tablet in Japanese patients with advanced solid malignancies

NCT ID

Therapeutic Area

Research Site

A Phase I, open-label study to assess the safety and tolerability of doses of olaparib tablet in Japanese patients with advanced solid malignancies

Age Continuous

Sex: Female, Male

Primary tumour location

Study Specific Characteristic

Overall Number of Participants Analyzed

At least 1 Adverse Events (AE)

At least 1 AE of CTCAE Grade 3 or higher

At least 1 Serious Adverse Events (SAE)

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.

Number of Participants With Adverse Events

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.

All patients in only the dose escalation part who received olaparib and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.

Number of Participants With Dose Limiting Toxicities

Cmax following single dosing

Dose escalation part only.
Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.

Cmax following multiple dosing

tmax following single dosing

tmax following multiple dosing

Dose escalation part only.
One participant in 200 mg bid had no AUC data because AUC was not calculable for this participant.

AUC following single dosing

AUC at steady state following multiple dosing

Overall Study

A total of 28 participants gave informed consent to join this study. Five participants were screen failures so that 23 participants were assigned and received study treatment

Medical Director

Day 1 and 2 single dose period. Day 1 and 15 multiple dose period day. Pre dose of single dose period day 1 at: 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 12h,day 2 at 24h and day 3 at 48h (same day as multiple dose period day 1). Pre dose of multiple dose period day 15 at: 0:15, 0:30, 1, 1:30, 2, 3, 4, 6, 8h and 12h

Investigate the safety and tolerability of olaparib tablet in Japanese patients with advanced solid malignancies

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D081BC00001_Study_Report_Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator