[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.

Official Title
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Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer

Conditions
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Ovarian Neoplasm

Intervention / Treatment
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* Drug: Pazopanib and paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosis of relapsed ovarian cancer Responded to at least on one line of prior platinum based therapy Relapsed within platinum resistant interval (≤6months) Eastern Cooperative Oncology Group (ECOG) performance status of <2 Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques Satisfactory baseline haematologic and organ function: Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1 Exclusion Criteria: 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. Treatment with any of the following anti-cancer therapies: radiation therapy 28 days prior to the first dose of pazopanib OR surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR 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 Treatment with anti-angiogenic therapy Presence of gross ascites Clinically significant peripheral neuropathy Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pazopanib and paclitaxel<br> | Drug: Pazopanib and paclitaxel<br>* Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment | Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of women who experience side effects from the combination of paclitaxel and pazopanib | Core study assessments including physical examination, vital signs, ECG, and adverse event reporting | 12 months | 
| The proportion of patients responding to combination paclitaxel and pazopanib |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platinum resistant, ovarian cancer