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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003262-41 | EudraCT Number |
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This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Paclitaxel, GDC-0941 | Experimental | Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle. |
|
| B: Paclitaxel, Placebo | Placebo Comparator | Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m^2 IV weekly for 3 out of 4 weeks in every 28-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | GDC-0941 will be administered QD orally for 5 consecutive days each week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | From the time of randomization until disease progression or death from any cause (up to approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | From randomization up to approximately 3 years | |
| Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1 | From first observation of an objective tumor response until disease progression (up to approximately 3 years) |
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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 |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - NAHOA | Sedona | Arizona | 86336 | United States | ||
| Pacific Cancer Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27573562 | Derived | Vuylsteke P, Huizing M, Petrakova K, Roylance R, Laing R, Chan S, Abell F, Gendreau S, Rooney I, Apt D, Zhou J, Singel S, Fehrenbacher L. Pictilisib PI3Kinase inhibitor (a phosphatidylinositol 3-kinase [PI3K] inhibitor) plus paclitaxel for the treatment of hormone receptor-positive, HER2-negative, locally recurrent, or metastatic breast cancer: interim analysis of the multicentre, placebo-controlled, phase II randomised PEGGY study. Ann Oncol. 2016 Nov;27(11):2059-2066. doi: 10.1093/annonc/mdw320. Epub 2016 Aug 29. |
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| Placebo | Drug | Placebo matching to GDC-0941 |
|
| Paclitaxel | Drug | Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle. |
|
| Percentage of Participants Acheiving Clinical Benefit (Partial Response, Complete Response or Stable Disease Lasting for at Least 6 Months) Assessed as per Modified RECIST v1.1 | From randomization until disease progression (up to approximately 3 years) |
| Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1 | From first observation of an objective tumor response until disease progression (up to approximately 3 years) |
| Population Pharmacokinetics (PK) for GDC-0941 | Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days) |
| Population PK for Paclitaxel | Day 1 of Cycle 1 (cycle length=28 days) |
| Anaheim |
| California |
| 92801 |
| United States |
| California Cancer Associates for Research & Excellence, Inc. | Encinitas | California | 92008 | United States |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | United States |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | United States |
| Bay Area Cancer Research Group, LLC | Pleasant Hill | California | 94523 | United States |
| Kaiser Permanente Medical Center - Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | United States |
| Kaiser Permanente - San Francisco (2238 Geary) | San Francisco | California | 94115 | United States |
| University of California at San Francisco | San Francisco | California | 94115 | United States |
| Kaiser Permanente - San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente - South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research | Hartford | Connecticut | 06102-5037 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Cancer Specialists of North Florida | Orange Park | Florida | 32073 | United States |
| Hematology - Oncology Associates of Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| Joliet Oncology-Hematology; Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Oncology Specialists, S.C. | Park Ridge | Illinois | 60068 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center | Topeka | Kansas | 66606 | United States |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | 70808 | United States |
| Metairie Oncologist, LLC | Metairie | Louisiana | 70006 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Beth Israel Deaconess Med Ctr | Brookline | Massachusetts | 02445 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Billings Clinic Cancer Center-CCD PRIME | Billings | Missouri | Montana | United States |
| Nebraska Cancer Specialists; Oncology Hematology West, PC | Omaha | Nebraska | 68130 | United States |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Aultman Hospital; Aultman Hospital Cancer Center | Canton | Ohio | 44710 | United States |
| TriHealth Oncology Institute | Cincinnati | Ohio | 45247 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Hematology and Oncology Associates of Sc | Greenville | South Carolina | 29615 | United States |
| Shivers Cancer Center at University Medical Center Brackenridge | Austin | Texas | 78701 | United States |
| Texas Oncology | Bedford | Texas | 76022 | United States |
| Texas Oncology, P.A. - El Paso; West | El Paso | Texas | 79902 | United States |
| Texas Oncology - Memorial City | Houston | Texas | 77024 | United States |
| Texas Oncology, P.A. ;Sherman Cancer Center | Sherman | Texas | 75090-0504 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| Shenandoah Oncology Associates | Winchester | Virginia | 22601 | United States |
| Puget Sound Cancer Centers | Edmonds | Washington | 98026 | United States |
| Swedish Health Services | Seattle | Washington | 98122 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Port Macquarie Base Hospital;North Coast Cancer Institute | Port Macquarie | New South Wales | 2444 | Australia |
| Sydney Haematology & Oncology Clinic | Wahroonga | New South Wales | 2076 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Border Medical Oncology | Wodonga | New South Wales | 3690 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mater Adult Hospital | Mackay | Queensland | 4740 | Australia |
| Ashford Cancer Center Research | Kurralta Park | South Australia | 5037 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Bendigo Hospital; Oncology | Bendigo | Victoria | 3550 | Australia |
| Peninsula and South Eastern Haematology and Oncology Grou | Frankston | Victoria | 3199 | Australia |
| Royal Perth Hospital; Medical Oncology | Perth | Western Australia | 6000 | Australia |
| Lkh-Univ. Klinikum Graz | Graz | 8036 | Austria |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria |
| Krankenhaus Hietzing m.Neurolog. Zentrum Rosenhuegel | Vienna | 1130 | Austria |
| Klinikum Wels-Grieskirchen | Wels | 4600 | Austria |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Ambroise Paré | Mons | 7000 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Fakultni nemocnice Brno | Brno | 613 00 | Czechia |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Krajska nemocnice Liberec a.s. | Liberec | 460 63 | Czechia |
| Multiscan s.r.o. | Pardubice | 532 03 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 01 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Institut Catala d´Oncologia Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital General Univ. Gregorio Maranon | Madrid | 28009 | Spain |
| START Madrid. Centro Integral Oncologico Clara Campal; CIOCC | Madrid | 28050 | Spain |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Royal Surrey County Hospital | Guildford | GU2 7XX | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Barts Hospital | London | E1 2EF | United Kingdom |
| The Christie | Manchester | M20 4BX | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham University Hospitals City Campus | Nottingham | NG5 1PB | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LQ | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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