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| ID | Type | Description | Link |
|---|---|---|---|
| GO00766 | Other Identifier | Hoffmann-La Roche |
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This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMUC5754A | Drug | Escalating intravenous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Up to 21 days | |
| Nature of dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.0 | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 1 year | |
| Nature of adverse events graded per NCI CTCAE v4.0 | Up to 1 year | |
| Severity of adverse events |
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Inclusion Criteria:
Inclusion Criteria Specific to Patients with Ovarian Cancer:
Inclusion Criteria Specific to Patients with Pancreatic Cancer:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 02114 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27793850 | Derived | Liu JF, Moore KN, Birrer MJ, Berlin S, Matulonis UA, Infante JR, Wolpin B, Poon KA, Firestein R, Xu J, Kahn R, Wang Y, Wood K, Darbonne WC, Lackner MR, Kelley SK, Lu X, Choi YJ, Maslyar D, Humke EW, Burris HA. Phase I study of safety and pharmacokinetics of the anti-MUC16 antibody-drug conjugate DMUC5754A in patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer. Ann Oncol. 2016 Nov;27(11):2124-2130. doi: 10.1093/annonc/mdw401. |
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| Up to 1 year |
| Area under the concentration-time curve | up to 1 year |
| Maximum concentrations | up to 1 year |
| Minimum concentrations | up yo 1 year |
| Clearance | up to 1 year |
| Half-life | up to 1 year |
| Volume of distribution | up to 1 year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic 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 |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
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| ID | Term |
|---|---|
| C000625656 | DMUC5754A |
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