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[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer (PAZPET-1)

Primary Purpose

Ovarian Neoplasm

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Pazopanib and paclitaxel
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasm focused on measuring platinum resistant, ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College Healthcare NHS Trust
  • Southend University Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pazopanib and paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
The proportion of patients responding to combination paclitaxel and pazopanib

Full Information

First Posted
March 22, 2012
Last Updated
March 9, 2017
Sponsor
Imperial College London
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01608009
Brief Title
[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasm
Keywords
platinum resistant, ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pazopanib and paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pazopanib and paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment
Description
Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The proportion of women who experience side effects from the combination of paclitaxel and pazopanib
Description
Core study assessments including physical examination, vital signs, ECG, and adverse event reporting
Time Frame
12 months
Title
The proportion of patients responding to combination paclitaxel and pazopanib
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohini Sharma, MD
Organizational Affiliation
Imperial College London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timothy Crook, MD
Organizational Affiliation
Southend University Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Southend
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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