Study of a marker of angiogenic response to combination therapy with pazopanib, and weekly paclitaxel in platinum resistant ovarian cancer

Phase 1

Completed

• Conditions: Gynaecological cancer, ovarian cancer; Cancer; Malignant neoplasm of ovary

• Registration Number: ISRCTN38286161
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-10
• Study Completion: 2012-11-01
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

1. Age over 18 years
2. Diagnosis of relapsed ovarian cancer
3. Responded to at least on one line of prior platinum based therapy
4. Relapsed within platinum resistant interval (=6months)
5. Eastern Cooperative Oncology Group (ECOG) performance status of <2
6. Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter = 25mm using conventional techniques
7. Adequate organ system function
8. Female participants only

Exclusion Criteria

1. 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.
2. Treatment with any of the following anti-cancer therapies:
2.1. Radiation therapy 28 days prior to the first dose of pazopanib OR
2.2. Surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
2.3. 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
3. Treatment with anti-angiogenic therapy
4. Presence of gross ascites
5. Clinically significant peripheral neuropathy
6. Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to therapy

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures