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Completed

NCT Number: NCT01608009

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Imperial College Healthcare NHS Trust, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pazopanib and paclitaxel

Drug

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 outcomes

  1. Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment

    Time frame: 1 week

    Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant

Secondary outcomes

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

    Time frame: 12 months

    Core study assessments including physical examination, vital signs, ECG, and adverse event reporting

  2. The proportion of patients responding to combination paclitaxel and pazopanib

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: PAZPET-1

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
May 30, 2012
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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