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
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