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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pazopanib and paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pazopanib and paclitaxel | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment | Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of women who experience side effects from the combination of paclitaxel and pazopanib | Core study assessments including physical examination, vital signs, ECG, and adverse event reporting | 12 months |
| The proportion of patients responding to combination paclitaxel and pazopanib |
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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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Rohini Sharma, MD | Imperial College London | Study Director |
| Timothy Crook, MD | Southend University Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom | ||||
| Southend University Hospital NHS Foundation Trust |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2022 | |
| Reset | Jun 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2022 | Jun 30, 2023 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| 12 months |
| Southend |
| United Kingdom |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |