EU Clinical Trial Information System (CTIS)

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

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KU-0059436 administered orally twice daily

CSR_Synopsis_D0810C00002(KU36-92).pdf

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours.  To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients

A study to assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Research Site

A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients with Advanced Tumours.

Age Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

ECOG Performance Status

Study Specific Characteristic

BRCA status

Cancer Primary Site

Any Treatment-emergent adverse events (TEAEs)

Drug-Related TEAEs

TEAEs of CTCAE Grade 3 or 4

Drug-Related TEAEs CTCAE Grade 3 or 4

TEAEs of CTCAE Grade 3, 4 or 5

Drug-Related TEAEs CTCAE Grade 3, 4 or 5

TEAEs with Outcome=Death

SAEs (including events with outcome=death)

SAEs with Outcome Other than Death

TEAE Leading to Discontinuation (of Treatment)

Drug-Related TEAEs Leading to Discontinuation

Drug-Related TEAEs with Outcome=Death

Drug-Related SAEs

Drug-Related SAEs Leading to Discontinuation

Dose-limiting toxicities

The safety and tolerability profile of olaparib was assessed by adverse events (AEs), laboratory tests, physical examination and vital signs.

The maximum tolerated dose (MTD) was defined as 400 mg bd and the 200 mg bd dose of olaparib was chosen for further assessment of the tolerability and efficacy of olaparib.

AEs are further described in the "Adverse Events" section.

Safety Endpoint - Summary of Adverse Events

Overall  Response (CR + PR)

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Evaluation of tumour response was a secondary study objective. The primary measure of tumour response was the Overall Best Response reported after every two cycles of study drug until week 24 then every 12 weeks until confirmed progressive disease. Responses were confirmed at least four weeks (28 days) later for those participants with an initial positive response.

Participants with measurable disease were assessed by the international criteria proposed by the Response Evaluation Criteria in Solid Tumours (RECIST) Committee

Efficacy Endpoint - Overall Best Response

Duration of response

The duration of response was derived for participants with measurable disease at baseline and a confirmed on-study response of Complete Response (RECIST - CR) or Partial Response (RECIST - PR).  Duration of Response was calculated from the first day a confirmed PR or CR was observed until recurrence or PD was objectively documented (including symptomatic progression), or death due to disease progression (only including deaths during the on-study period).

Efficacy Endpoint - Duration of Response

Duration of SD

The duration of SD was derived for participants with measurable disease at baseline and an on-study response of SD per RECIST.
Duration of SD was calculated from the date of first study drug administration until PD was objectively documented (including symptomatic progression), or death due to disease progression (only including deaths during the on-study period).

Efficacy Endpoint - Duration of Stable Disease

Time to PD

Time to Disease Progression was calculated from the date of first study drug administration until objective progressive disease (RECIST - PD)/symptomatic deterioration or death due to progression (only including deaths during the on-study period) was observed. Participants who did not have progression during the study were censored at the last tumour assessment date or date of death from other causes. 
If two or more consecutive scheduled assessments had no data (incomplete assessment, not assessed, or missing), the Time to PD was calculated at the time of the last prior assessment with valid data. If a single assessment had no data, this assessment was ignored and any prior and subsequent assessments could be used to determine the Time to PD. 

Participants with measurable disease were assessed by the international criteria proposed by the RECIST Committee.

Efficacy Endpoint - Time to Disease Progression

Cmax at Cycle 1 Day 1(C1D1)

Dose normalised maximum plasma concentration (Cmax) following administration of a single dose of olaparib (C1D1).

PK Endpoint - Cmax at Cycle 1 Day 1 (C1D1)

AUC(0-10h) at C1D1

Dose normalised area under the plasma concentration-time curve (AUC) to 10 hours post-dose.

PK Endpoint - AUC(0-10h) at C1D1

max at C1D14

Dose normalised Cmax at steady state (Cmax ss) following administration of multiple doses of olaparib (C1D14).

PK Endpoint - Cmax at C1D14

AUC(0-10h) at C1D14

PK Endpoint - AUC(0-10h) at C1D14

Cmax at C2D1

Cmax at steady state (Cmax ss) following administration of multiple doses of olaparib (C2D1).

PK Endpoint - Cmax at C2D1

AUC(0-6h) at C2D1

AUC to 6 hours post-dose following administration of multiple doses of olaparib  (C2D1).

PK Endpoint - AUC(0-6h) at C2D1

tmax at C2D1

Time to reach maximum plasma concentration (tmax) at steady state (ss) following administration of multiple doses of olaparib (C2D1).

PK Endpoint - tmax at C2D1

Overall Study

Screening Details:
Male or female aged ≥18 years, with malignant advanced solid tumor refractory to standard therapy or no suitable effective standard therapy existed. Evaluable or measurable disease per RECIST. Adequate bone marrow, hepatic, and renal function. ECOG performance status of 0-2 at entry. Expansion phase: ovarian/breast/prostate cancer with BRCA1 or 2 mutation.

A study to assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

Official Title

Medical condition

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Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

CSR_Synopsis_D0810C00002(KU36-92).pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator