NCT00710268

Brief Summary

Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 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

June 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
8 months 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

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

June 30, 2008

Last Update Submit

January 13, 2015

Conditions

Neoplasm Metastasis

Keywords

BevacizumabPoly(ADP ribose) polymerasesMetastatic Solid TumoursPARP inhibitor

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam

    various timepoints.

Secondary Outcomes (1)

  • To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters

    various timepoints.

Study Arms (1)

1

EXPERIMENTAL

Dose Escalation Study 50, 100, 200, 400 mg

Drug: AZD2281Drug: Bevacizumab

Interventions

AZD2281DRUG

Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing

Also known as: Olaparib
1
BevacizumabDRUG

IV administration10 mg/kg every 14 days

Also known as: Avastin
1

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
  • Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol
  • Estimated life expectancy of at least 12 weeks

You may not qualify if:

  • Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event
  • Hypertension (high blood pressure) or significant cardiovascular disease
  • Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Manchester, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

olaparibBevacizumab

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • James Carmichael, BSc MBChB MD FRCP

    KuDOS Pharmaceuticals Ltd

    STUDY DIRECTOR

  • Malcolm Ranson

    Christie Hospital, Manchester, UK

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 4, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

November 1, 2009

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

GB(2)