- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00460278
Study of XL418 in Adults With Solid Tumors
2 juni 2008 uppdaterad av: Exelixis
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL418 Administered Orally Daily to Subjects With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects with solid tumors.
XL418 is a new chemical entity that inhibits a spectrum of targets, including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Förväntat)
63
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Wayne State University
-
-
Texas
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San Antonio, Texas, Förenta staterna, 78229
- South Texas Accelerated Research Therapeutics
-
-
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, for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
- The subject has disease that is assessable by tumor marker, physical, or radiologic means.
- The subject is ≥18 years old.
- The subject's weight is ≥55 kg and ≤120 kg.
- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- The subject has adequate organ and marrow function.
For subjects who are to be enrolled into the expanded MTD cohort:
- tumor tissue amenable to serial biopsy; and
- additional informed consent.
- The subject is capable of understanding the protocol 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.
- The subject has a normal fasting blood glucose level at screening.
- If a subject has received more than three prior regimens of cytotoxic chemotherapy, more than two biological regimens, or more than 3000 cGy to areas containing substantial marrow, the principal investigator (PI) and the sponsor will discuss subject suitability prior to enrollment.
- The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥5 years ago, with no evidence of disease for 5 years prior to screening for this study).
Exclusion Criteria:
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 30 days (6 weeks for nitrosoureas or mitomycin C) 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 XL418.
- The subject has not recovered either to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment.
- The subject has received another investigational agent within 30 days of the first dose of study drug.
- The subject has known brain metastases.
- The subject is known to have diabetes.
- The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- The subject has psychiatric illness/social situations that would limit compliance with study requirements.
- The subject is pregnant or breast feeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject has a known allergy or hypersensitivity to any of the components of the XL418 formulation.
- The subject has a baseline QTc interval >450 ms.
- The subject is unwilling or unable 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)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Safety, tolerability, and maximum tolerated dose of XL418 with daily oral administration
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Sekundära resultatmått
Resultatmått |
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Plasma pharmacokinetics and pharmacodynamic effects of daily oral administration of XL418
|
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 april 2007
Studieregistreringsdatum
Först inskickad
11 april 2007
Först inskickad som uppfyllde QC-kriterierna
11 april 2007
Första postat (Uppskatta)
13 april 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 juni 2008
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2008
Senast verifierad
1 juni 2008
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- XL418-001
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 .