TheranosticTrials.org

Clinical Trial · NCT01608009

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

Overview

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.

Sponsor

Imperial College London

Phase

Phase 1

Contacts

Timothy Crook, MD (PRINCIPAL_INVESTIGATOR)

Rohini Sharma, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01608009

Drug / Compound

Fluciclatide

Isotope(s):
Target(s):
  • αvβ3
Ligand Class: Peptides

Eligibility

Inclusion

  • Responded to at least on one line of prior platinum based therapy
  • Satisfactory baseline haematologic and organ function:
  • Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques
  • Relapsed within platinum resistant interval (≤6months)
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of \<2
  • Diagnosis of relapsed ovarian cancer
  • Renal: Serum creatinine \< or = 1.5 mg/dL; Or if \>1.5 mg/dL, calculated creatinine clearance \> or = 50mL/min; UPC \<1
  • Hepatic: Bilirubin \< or = 1.5 X ULN; AST or ALT \< or = 2.5 X ULN

Exclusion

  • radiation therapy 28 days prior to the first dose of pazopanib OR
  • Clinically significant peripheral neuropathy
  • Treatment with anti-angiogenic therapy
  • Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
  • 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
  • Presence of gross ascites
  • 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:
  • surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR