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
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
government organisation
Funding Body Subtype
Federal/National Government
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