- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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. november 2016 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
108
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85258
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
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Michigan
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Detroit, Michigan, Forente stater, 48201
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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).
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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.
Andre navn:
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Eksperimentell: 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.
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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.
Andre navn:
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Eksperimentell: 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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Maximum Observed Concentration (Cmax) of GDC-0941
Tidsramme: 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)
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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)
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Terminal Elimination Half-Life (t1/2) of GDC-0941
Tidsramme: 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)
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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)
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Area Under the Concentration-Time Curve (AUC) of GDC-0941
Tidsramme: 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)
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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)
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Percentage of Participants with Adverse Events
Tidsramme: 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)
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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)
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Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Tidsramme: Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36
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Visits during treatment on Days 1, 2, 3, 4, 8, 15, 22, 29, 36
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Percentage of Participants with Grade 3 or 4 Abnormalities in Safety-Related Laboratory Parameters
Tidsramme: 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)
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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)
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Time of Maximum Observed Concentration (Tmax) of GDC-0941
Tidsramme: 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)
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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)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Duration of Objective Response According to RECIST
Tidsramme: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
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Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
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Progression-Free Survival (PFS) According to RECIST
Tidsramme: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
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Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
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Percentage of Participants by Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Tidsramme: Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
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Tumor assessments as Baseline, Day 36, and every 8 weeks thereafter through Cycle 12 (up to 1 year overall)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Jerry Hsu, M.D., Genentech, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2007
Primær fullføring (Faktiske)
1. juni 2012
Studiet fullført (Faktiske)
1. november 2013
Datoer for studieregistrering
Først innsendt
13. mars 2009
Først innsendt som oppfylte QC-kriteriene
3. april 2009
Først lagt ut (Anslag)
6. april 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- GDC4255g
- GO01300 (Annen identifikator: Hoffmann-La Roche)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .