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

Ovarian Neoplasm Clinical Trial

— PAZPET-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608009
• Other study ID #: CRO1627
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2012
• Last updated: March 9, 2017
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Neoplasm
• Ovarian Neoplasms

Intervention

Drug:
• Pazopanib and paclitaxel
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.

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Southend University Hospital NHS Foundation Trust	Southend

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The proportion of patients responding to combination paclitaxel and pazopanib		12 months