A Study to Assess the Safety and Pharmacokinetics of an I... | NCT00516373

Studies
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

NCT00516373

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 22, 2024Actual

Enrollment

98Actual

Phase

Phase 1

Conditions

Ovarian Neoplasms
BRCA1 Protein
BRCA2 Protein

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)

Countries

Belgium
Netherlands
Poland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2005Actual

Primary Completion Date

Dec 17, 2008Actual

Completion Date

Apr 26, 2023Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2024

Last Update Posted Date

Feb 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KU-0059436	Experimental	KU-0059436 administered orally twice daily	Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KU-0059436 (AZD2281)(PARP inhibitor)	Drug	oral	KU-0059436	Olaparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436		assessed at each visit

Secondary Outcomes

Measure	Description	Time Frame
Objective tumour response		assessed every 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

130 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jane Robertson, BSc, MBCHB, MD	AstraZeneca	Study Director
Dr. Johann De Bono, PhD MRCP FRCR	Royal Marsden Hospital Trust, London, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Brussels		1090	Belgium
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26961146	Derived	Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.
23922302

See Also Links

Label	URL
CSR\_Synopsis\_D0810C00002(KU36-92).pdf	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
C563980	Fanconi Anemia, Complementation Group D1

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531550	olaparib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
D0810C00002
2005-001435-29	EudraCT Number