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This is a multicenter, single-arm, open-label Phase II study to evaluate the activity of GDC-0980 in patients with recurrent or persistent endometrial cancer. The safety, tolerability, and pharmacokinetics of GDC-0980 will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0980 | Drug | Oral daily dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response as assessed by the investigator using RECIST v1.1 | up to approximately 23 months | |
| Progression-free survival (PFS), defined as the time from the first GDC-0980 treatment to disease progression as assessed by the investigator using RECIST v1.1, or death from any cause while on study | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS), defined as the time from treatment initiation until death from any cause | up to approximately 36 months | |
| Duration of objective tumor response defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85013 | United States | |||
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| up to approximately 23 months |
| Incidence of adverse events | up to approximately 23 months |
| Nature of adverse events | up to approximately 23 months |
| Severity of adverse events | up to approximately 23 months |
| Newport Beach |
| California |
| 92663 |
| United States |
| Orange | California | 92868 | United States |
| Palo Alto | California | 94305 | United States |
| San Francisco | California | 94115 | United States |
| Denver | Colorado | 80220 | United States |
| New Haven | Connecticut | 06511 | United States |
| Boca Raton | Florida | 33487 | United States |
| Orlando | Florida | 32804 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Hinsdale | Illinois | 60521 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Louisville | Kentucky | 40202 | United States |
| Scarborough | Maine | 04074 | United States |
| Baltimore | Maryland | 21231 | United States |
| Boston | Massachusetts | 02115-6084 | United States |
| Boston | Massachusetts | 02215 | United States |
| Voorhees Township | New Jersey | 08043 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10017 | United States |
| Durham | North Carolina | 27710 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Abington | Pennsylvania | 19001 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Salt Lake City | Utah | 84112 | United States |
| Seattle | Washington | 98195 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C569670 | 1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one |
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