- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00876109
A Study of GDC-0941 in Participants With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable
1. listopadu 2016 aktualizováno: Genentech, Inc.
An Open-Label, Phase I, Dose-Escalation Study Evaluating Two Dosing Schedules of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily (QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
108
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Arizona
-
Scottsdale, Arizona, Spojené státy, 85258
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02215
-
-
Michigan
-
Detroit, Michigan, Spojené státy, 48201
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Participants with histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen, and who are not candidates for regimens known to provide clinical benefit
- Evaluable or measurable disease per RECIST
- Life expectancy of greater than or equal to (>/=) 12 weeks
- Documented willingness to use an effective means of contraception (for both men and women) while participating in the study
Exclusion Criteria:
- Leptomeningeal disease as the only manifestation of the current malignancy
- History of Type 1 or 2 diabetes mellitus requiring regular medication
- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
- Malabsorption syndrome or other condition that would interfere with enteral absorption
- Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >/=3 months
- Active congestive heart failure or ventricular arrhythmia requiring medication
- Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
- Active infection requiring intravenous (IV) antibiotics
- Requirement for any daily supplemental oxygen
- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal (LLN), or hypercalcemia above the upper limit of normal (ULN) for the institution despite adequate electrolyte supplementation or management
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus (HIV) infection
- Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk from treatment complications
- Significant traumatic injury within 3 weeks before Day 1
- Major surgical procedure within 4 weeks prior to initiation of study treatment
- Treatment with chemotherapy, hormonal therapy (except gonadotropin releasing hormone [GnRH] agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
- Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
- Need for chronic corticosteroid therapy for greater than (>) 7 days
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Group A: GDC-0941 QD Dose Escalation
Participants will receive GDC-0941 for up to 1 year, administered orally QD at a starting dose of 15 milligrams (mg).
|
GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively.
In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.
Ostatní jména:
|
|
Experimentální: Group B: GDC-0941 BID Dose Escalation
Participants will receive GDC-0941 for up to 1 year, administered orally BID at a starting dose determined from Group A assessments.
|
GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively.
In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.
Ostatní jména:
|
|
Experimentální: Group C: GDC-0941 QD or BID Expansion
Participants will receive GDC-0941 for up to 1 year, administered orally QD or BID.
The dose/regimen will be determined on the basis of data from Groups A and B.
|
GDC-0941 will be administered in escalating oral doses QD or BID in Groups A and B, respectively.
In Group C, the dose/regimen will be determined on the basis of data from Groups A and B. The overall starting dose will be 15 mg administered in the first cohort enrolled in Group A.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Maximum Observed Concentration (Cmax) of GDC-0941
Časové okno: Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
|
Terminal Elimination Half-Life (t1/2) of GDC-0941
Časové okno: Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
|
Area Under the Concentration-Time Curve (AUC) of GDC-0941
Časové okno: Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
Pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 h) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
|
Percentage of Participants with Adverse Events
Časové okno: Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall)
|
Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall)
|
|
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Časové okno: Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36
|
Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36
|
|
Percentage of Participants with Grade 3 or 4 Abnormalities in Safety-Related Laboratory Parameters
Časové okno: Visits at Baseline and during treatment on Days 1, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall)
|
Visits at Baseline and during treatment on Days 1, 8, 15, 22, 29, 36; weekly during Cycle 2; every two weeks during Cycles 3 to 6; every month during Cycles 7 to 12; and up to 30 days after last dose (up to 1 year overall)
|
|
Time of Maximum Observed Concentration (Tmax) of GDC-0941
Časové okno: Pre-dose (5 minutes [min]) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 hours [h]) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
Pre-dose (5 minutes [min]) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72 hours [h]) Day 1; pre-dose (5 min) and post-dose (0.5, 1, 2, 3, 4, 8, 12, 24 h) Days 8 and 15; pre-dose (5 min) Days 22, 29, 36, and end of Cycles 1 to 12 (up to 1 year overall)
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Duration of Objective Response According to RECIST
Časové okno: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
|
Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
|
|
Progression-Free Survival (PFS) According to RECIST
Časové okno: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
|
Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
|
|
Percentage of Participants by Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Časové okno: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
|
Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Jerry Hsu, M.D., Genentech, Inc.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2007
Primární dokončení (Aktuální)
1. června 2012
Dokončení studie (Aktuální)
1. listopadu 2013
Termíny zápisu do studia
První předloženo
13. března 2009
První předloženo, které splnilo kritéria kontroly kvality
3. dubna 2009
První zveřejněno (Odhad)
6. dubna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
2. listopadu 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. listopadu 2016
Naposledy ověřeno
1. listopadu 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- GDC4255g
- GO01300 (Jiný identifikátor: Hoffmann-La Roche)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Solidní rakoviny
-
Peking Union Medical College HospitalNábor
-
Navire Pharma Inc., a BridgeBio companyUkončenoTumor, SolidSpojené státy
-
Evopoint Biosciences Inc.Cancer Institute and Hospital, Chinese Academy of Medical SciencesNábor
-
Peking UniversityZatím nenabíráme
-
Varian, a Siemens Healthineers CompanyDokončeno
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); National Institutes of Health (NIH)Ukončeno
-
Merck Sharp & Dohme LLCUkončeno
-
Varian, a Siemens Healthineers CompanyDokončeno
-
Eikon TherapeuticsSeven and EightDokončenoTumor, SolidSpojené státy
Klinické studie na GDC-0941
-
Merck Sharp & Dohme LLCDokončeno
-
Merck Sharp & Dohme LLCDokončeno
-
Merck Sharp & Dohme LLCDokončeno
-
Genentech, Inc.DokončenoNon-Hodgkinův lymfom, solidní rakovinaSpojené království
-
Genentech, Inc.DokončenoZdravý dobrovolníkSpojené státy
-
Genentech, Inc.DokončenoZdravý dobrovolníkSpojené státy
-
Merck Sharp & Dohme LLCDokončenoCukrovka typu 2
-
Genentech, Inc.Ukončeno
-
Lupin Research IncDokončenoBakteriální vaginózySpojené státy
-
Genentech, Inc.Dokončeno