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

NCT ID: NCT01608009

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Ovarian Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pazopanib and paclitaxel

Group Type: EXPERIMENTAL

Pazopanib and paclitaxel

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohini Sharma, MD

Role: STUDY_DIRECTOR

Imperial College London

Timothy Crook, MD

Role: PRINCIPAL_INVESTIGATOR

Southend University Hospital NHS Foundation Trust

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Southend University Hospital NHS Foundation Trust

Southend, , United Kingdom

Countries

United Kingdom

Other Identifiers

CRO1627

Identifier Type: -

Identifier Source: org_study_id