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Study of a marker of angiogenic response to combination therapy with pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38286161
Enrollment
17
Registered
2011-08-10
Start date
2011-11-01
Completion date
Unknown
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynaecological cancer, ovarian cancer Cancer Malignant neoplasm of ovary

Interventions

fluciclatide-PET, PET imaging technique with novel tracer

Sponsors

Imperial College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Response to therapy

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026