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The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. This study will use a standard treatment regimen of pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies to evaluate the efficacy of this combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB-485232 plus pegylated liposomal doxorubicin | Experimental | Subjects will receive one dose of pegylated liposomal doxorubicin on Day 1 plus two doses of SB-485232 on Day 3 and Day 9 in each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-485232 (interleukin 18), pegylated liposomal doxorubicin | Drug | SB-485232 (interleukin 18), pegylated liposomal doxorubicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SB-485232/Doxil combination therapy | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biological activity of SB-485232/Doxil combination therapy | 16 weeks | |
| Pharmacokinetic parameters for SB-485232 and Doxil: AUC(0-t), Cmax, and Cmin | 16 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Stanford | California | 94305-5317 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study ILI108621 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| ILI108621 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 |
|---|---|
| D020382 | Interleukin-18 |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| Pharmacodynamic biomarker responses |
| 16 weeks |
| Immunogenicity (anti-SB-485232 and anti-PEG antibodies) | 16 weeks |
| Anti-tumor activity (Radiographic tumor assessments and serum CA-125 levels) | 16 weeks |
| Miami |
| Florida |
| 33136 |
| United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| ILI108621 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ILI108621 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ILI108621 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ILI108621 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ILI108621 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ILI108621 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |