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| ID | Type | Description | Link |
|---|---|---|---|
| GO00885 | Other Identifier | Hoffmann-La Roche | |
| 2011-000493-56 | EudraCT Number |
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Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Active Comparator | Participants will receive everolimus (10 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
|
| GDC-0980 | Experimental | Participants will receive GDC-0980 (40 mg) orally daily until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus will be administered orally at a 10 mg daily dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1 | Baseline until disease progression or death, whichever occurred first (up to approximately 23 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of GDC-0980 | pre-dose and 1, 2, 4 hours post-dose on Week 1 Day 1, Pre-dose on Week 1 Day 2, pre-dose and 2 hours post dose on Week 3 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months) | |
| Cmax of everolimus |
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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 |
|---|---|---|---|---|---|---|
| Fort Myers | Florida | 33908 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26951309 | Derived | Powles T, Lackner MR, Oudard S, Escudier B, Ralph C, Brown JE, Hawkins RE, Castellano D, Rini BI, Staehler MD, Ravaud A, Lin W, O'Keeffe B, Wang Y, Lu S, Spoerke JM, Huw LY, Byrtek M, Zhu R, Ware JA, Motzer RJ. Randomized Open-Label Phase II Trial of Apitolisib (GDC-0980), a Novel Inhibitor of the PI3K/Mammalian Target of Rapamycin Pathway, Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2016 May 10;34(14):1660-8. doi: 10.1200/JCO.2015.64.8808. Epub 2016 Mar 7. |
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| GDC-0980 |
| Drug |
GDC-0980 will be administered orally at a 40 mg daily dose. |
|
| pre-dose and 2, hours post-dose on Week 1 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)\n |
| Minimum plasma concentration (Cmin) of GDC-0980 | pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1 |
| Cmin of everolimus | pre-dose on Week 1 Day 1 and Week 9 Day 1 |
| Number of participants with adverse events | up to 30 days after end of treatment (approximately up to 23 months) |
| Number of participants with objective tumor response as assessed by the investigator using RECIST v1.1 | Baseline until disease progression or death, whichever occurred first (up to approximately 23 months) |
| Duration of objective tumour response as assessed by the investigator using RECIST v1.1 | Baseline until disease progression or death, whichever occurred first (up to approximately 23 months) |
| Duration of overall survival (OS) | Baseline until death (up to approximately 45 months) |
| St. Petersburg |
| Florida |
| 33705 |
| United States |
| Boston | Massachusetts | 02215 | United States |
| Las Vegas | Nevada | 89148 | United States |
| New York | New York | 10065 | United States |
| Durham | North Carolina | 27710 | United States |
| Cleveland | Ohio | 44195 | United States |
| Nashville | Tennessee | 37203 | United States |
| Bordeaux | 33075 | France |
| Paris | 75908 | France |
| Villejuif | 94800 | France |
| Berlin | 10117 | Germany |
| Hanover | 30625 | Germany |
| München | 81377 | Germany |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Leeds | LS9 7TF | United Kingdom |
| London | EC1A 7BE | United Kingdom |
| London | SW3 6JJ | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| 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 |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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