NCT01608009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

March 22, 2012

Last Update Submit

March 9, 2017

Conditions

Ovarian Neoplasm

Keywords

platinum resistantovarian cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The proportion of women who experience side effects from the combination of paclitaxel and pazopanib

    12 months

  • The proportion of patients responding to combination paclitaxel and pazopanib

    12 months

Study Arms (1)

Pazopanib and paclitaxel

EXPERIMENTAL
Drug: Pazopanib and paclitaxel

Interventions

Pazopanib and paclitaxelDRUG

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.

Pazopanib and paclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Southend, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

pazopanibPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Rohini Sharma, MD

    Imperial College London

    STUDY DIRECTOR

  • Timothy Crook, MD

    Southend University Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

May 30, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2015

Study Completion

April 1, 2016

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

GB(2)