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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabectedin + PLD | Trabectedin + PLD according to SmPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabectedin + PLD | Drug | Combination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1). | Patient will be followed during 37 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death | Patient will be followed during 37 weeks |
| Safety according to CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed ovarian cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suriya Yessentaeva, PhD | Contact | +77077942910 | surya_esentay@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almaty oncological center | Recruiting | Almaty | Kazakhstan |
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To assess patient safety and the tolerance of trabectedin + PLD
| Patient will be followed during 37 weeks |
| Almaty regional oncological dispensary | Recruiting | Almaty | Kazakhstan |
|
| Kazakh institute of oncology and radiology | Recruiting | Almaty | Kazakhstan |
|
| Kazakh institute of oncology and radiology | Recruiting | Almaty | Kazakhstan |
|
| Astana Oncology Center | Recruiting | Astana | Kazakhstan |
|
| Kyzylorda regional Oncological center | Recruiting | Kyzylorda | Kazakhstan |
|
| West Kazakhstan regional oncology dispensary | Recruiting | Oral | Kazakhstan |
|
| North Kazakhstan Regional Oncology Center | Recruiting | Petropavl | Kazakhstan |
|
| South Kazakhstan regional oncologic dispensary | Recruiting | Shymkent | Kazakhstan |
|
| East Kazakhstan Regional Oncology Dispensary | Recruiting | Ust-Kamenogorsk | Kazakhstan |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| C041277 | 1-dodecylpyridoxal |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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