NCT00516438

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2007

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

1.7 years

First QC Date

August 13, 2007

Last Update Submit

December 7, 2010

Conditions

Malignant Solid Tumors

Keywords

malignant solid tumoursPoly(ADP ribose)polymerases

Outcome Measures

Primary Outcomes (1)

  • To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan

    assessed at each visit

Secondary Outcomes (1)

  • To identify the dose limiting toxicity of the combination therapy

    assessed at each visit

Study Arms (1)

1

EXPERIMENTAL

Topotecan + KU-0059436

Drug: KU-0059436 (AZD2281)(PARP inhibitor)Drug: Topotecan

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)DRUG

oral

Also known as: Olaparib
1
TopotecanDRUG

intravenous infusion

Also known as: Hycamtin®, Topotecan hydrochloride
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Glasgow, United Kingdom

Location

Research Site

Leicester, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Interventions

olaparibTopotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • James Cassidy

    Beaston Oncology Centre, Glasgow, UK

    PRINCIPAL INVESTIGATOR

  • James Carmichael, BSc MBChB MD FRCP

    KuDOS Pharmaceutical Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

November 1, 2009

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

GB(3)