This trial is active, not recruiting.

Condition ovarian neoplasm
Treatment pazopanib and paclitaxel
Phase phase 1
Sponsor Imperial College London
Collaborator GlaxoSmithKline
Start date July 2012
End date May 2015
Trial size 17 participants
Trial identifier NCT01608009, CRO1627


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
pazopanib and paclitaxel
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

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

Secondary Outcomes

The proportion of women who experience side effects from the combination of paclitaxel and pazopanib
time frame: 12 months
The proportion of patients responding to combination paclitaxel and pazopanib
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Timothy Crook, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Imperial College London.