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

Phase 1

Completed

• Conditions: Ovarian Neoplasm
• Interventions: Drug: Pazopanib and paclitaxel

• Registration Number: NCT01608009
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-30
• Study Start: 2012-07
• Primary Completion: 2015-05
• Study Completion: 2016-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pazopanib and paclitaxel	Pazopanib and paclitaxel	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Southend University Hospital NHS Foundation Trust; 🇬🇧 Southend, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom