Condition category
Cancer
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
25/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Rohini Sharma

ORCID ID

Contact details

MRC Cyclotron Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9301

Study information

Scientific title

Phase 1b exploratory study of [18F]AH111585-PET as a marker of angiogenic response to combination therapy with the pan-VEGF inhibitor, pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer

Acronym

PAZ-PET

Study hypothesis

Pazopanib is an unlicensed drug in tablet form that mainly targets the blood vessels supplying tumours and works best alongside other chemotherapy drugs. It attacks the protein on the blood vessels that is thought to be responsible for the resistance to chemotherapy. Paclitaxel is a licensed type of chemotherapy that is used to treat cancers and has been shown not only to shrink cancers but also target the abnormal blood vessels that supply nutrients to the cancer.
The study uses PET (Positron Emission Tomography) scanner along with a very small amount of radioactive substance called "Tracer". As the blood vessels that supply nutrients to the tumour are destroyed there will be less of the tracer seen around the tumour. The PET scanner can detect that and gives us an idea about what is happening to the blood vessels that supply nutrients to the tumour. We collect blood and biopsy samples from patients and they will later be tested to gain more of an understanding about the way that the chemotherapy works and how good the scans are at detecting the chemotherapy changes.

Ethics approval

ref: 10/S0801/36

Study design

Non-randomised, interventional study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Gynaecological cancer, ovarian cancer

Intervention

fluciclatide-PET, PET imaging technique with novel tracer

Intervention type

Drug

Phase

Phase I/II

Drug names

Paclitaxel, pazopanib

Primary outcome measures

Response to therapy

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2011

Overall trial end date

01/11/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 years
2. Diagnosis of relapsed ovarian cancer
3. Responded to at least on one line of prior platinum based therapy
4. Relapsed within platinum resistant interval (=6months)
5. Eastern Cooperative Oncology Group (ECOG) performance status of <2
6. Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter = 25mm using conventional techniques
7. Adequate organ system function
8. Female participants only

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 17; UK Sample Size: 17

Participant exclusion criteria

1. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg].
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
2. Treatment with any of the following anti-cancer therapies:
2.1. Radiation therapy 28 days prior to the first dose of pazopanib OR
2.2. Surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
2.3. Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
3. Treatment with anti-angiogenic therapy
4. Presence of gross ascites
5. Clinically significant peripheral neuropathy
6. Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

Recruitment start date

01/11/2011

Recruitment end date

01/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Cyclotron Unit
London
W12 0HS
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Industry

Funder name

GSK (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Higher Education Funding Council for England

Alternative name(s)

HEFCE

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

25/02/2016: No publications found, verifying study status with principal investigator.