Study to Assess the Safety and Tolerability of a PARP Inh... | NCT00516438

Studies
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan

NCT00516438

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 8, 2010Estimated

Enrollment

48Estimated

Phase

Phase 1

Conditions

Malignant Solid Tumors

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)
Topotecan

Countries

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

ID	Type	Description	Link
D0810C00006

Status Module

Record Verification Date

Dec 2010

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 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Nov 2009Actual

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

Dec 7, 2010

Last Update Posted Date

Dec 8, 2010Estimated

Name	Class
KuDOS Pharmaceuticals Limited	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours

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

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Topotecan + KU-0059436	Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Topotecan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KU-0059436 (AZD2281)(PARP inhibitor)	Drug	oral	1	Olaparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan		assessed at each visit

Secondary Outcomes

Measure	Description	Time Frame
To identify the dose limiting toxicity of the combination therapy		assessed at each visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
Evaluable disease
Adequate bone marrow, hepatic and renal function

Exclusion Criteria:

Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
Co-existing active infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Cassidy	Beaston Oncology Centre, Glasgow, UK	Principal Investigator
James Carmichael, BSc MBChB MD FRCP	KuDOS Pharmaceutical Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Glasgow			United Kingdom
Research Site

Intervention Browse Module

MeSH Terms

ID	Term
C531550	olaparib
D019772	Topotecan

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided