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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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Ovarian Neoplasm

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

1 week

Safety Issue:

No

Principal Investigator

Rohini Sharma, MD

Investigator Role:

Study Director

Investigator Affiliation:

Imperial College London

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CRO1627

NCT ID:

NCT01608009

Start Date:

July 2012

Completion Date:

May 2014

Related Keywords:

  • Ovarian Neoplasm
  • platinum resistant
  • ovarian cancer
  • Neoplasms
  • Ovarian Neoplasms

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