Study of a marker of angiogenic response to combination therapy with pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer
ISRCTN | ISRCTN38286161 |
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DOI | https://doi.org/10.1186/ISRCTN38286161 |
ClinicalTrials.gov number | NCT01608009 |
Secondary identifying numbers | 9301, CRO1627 |
- Submission date
- 10/08/2011
- Registration date
- 10/08/2011
- Last edited
- 20/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Rohini Sharma
Scientific
Scientific
MRC Cyclotron Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
Study design | Non-randomised, interventional study |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | GP practice |
Study type | Treatment |
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 |
Study acronym | PAZPET-1 |
Study objectives | 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(s) | ref: 10/S0801/36 |
Health condition(s) or problem(s) studied | Gynaecological cancer, ovarian cancer |
Intervention | fluciclatide-PET, PET imaging technique with novel tracer |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase I/II |
Drug / device / biological / vaccine name(s) | Paclitaxel, pazopanib |
Primary outcome measure | Response to therapy |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/11/2011 |
Completion date | 01/11/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | Planned Sample Size: 17; UK Sample Size: 17 |
Key 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 |
Key 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 |
Date of first enrolment | 01/11/2011 |
Date of final enrolment | 01/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Cyclotron Unit
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom
Website | http://www3.imperial.ac.uk/ |
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https://ror.org/041kmwe10 |
Funders
Funder type
Industry
GSK (UK)
No information available
Higher Education Funding Council for England
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HEFCE
- Location
- United Kingdom
Medical Research Council
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
20/03/2019: No publications found, verifying study status with principal investigator.
06/03/2018: No publications found, verifying study status with principal investigator.
25/02/2016: No publications found, verifying study status with principal investigator.