- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00526838
Study of XL228 Administered Intravenously to Subjects With Advanced Malignancies
19 augusti 2015 uppdaterad av: Exelixis
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Advanced Malignancies
The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
84
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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California
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Los Angeles, California, Förenta staterna, 90095
- UCLA Jonsson Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Winship Cancer Institute of Emory University
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan Health System
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- The subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other eligibility requirements must also be met.
- The subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means.
- The subject is ≥18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- The subject has adequate organ and marrow function.
- The subject is capable of understanding the informed consent document and has signed the informed consent document.
- Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
Exclusion Criteria:
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug.
- The subject has received radiation to >25% of his or her bone marrow within 30 days of treatment with XL228.
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
- The subject has a primary brain tumor. Subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
- The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- The subject has a psychiatric illness or social situation that would limit compliance with study requirements.
- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject has a known allergy or hypersensitivity to components of the XL228 formulation.
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 1
dosering en gång i veckan
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1-timmes IV-infusion
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Experimentell: 2
dosering två gånger i veckan
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1-timmes IV-infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
Tidsram: Assessed at periodic visits
|
Assessed at periodic visits
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To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Tidsram: Assessed at periodic visits
|
Assessed at periodic visits
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
To evaluate plasma pharmacokinetics of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Tidsram: Assessed at periodic visits
|
Assessed at periodic visits
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To evaluate preliminary safety and efficacy of XL228 when administered at the once-weekly MTD
Tidsram: Assessed at periodic visits
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Assessed at periodic visits
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2007
Primärt slutförande (Faktisk)
1 december 2010
Avslutad studie (Faktisk)
1 december 2010
Studieregistreringsdatum
Först inskickad
6 september 2007
Först inskickad som uppfyllde QC-kriterierna
6 september 2007
Första postat (Uppskatta)
10 september 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 augusti 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 augusti 2015
Senast verifierad
1 augusti 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- XL228-002
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på XL228
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ExelixisAvslutadKronisk myeloid leukemi | Leukemi, lymfoblastisk, akut, Philadelphia-positivFörenta staterna