- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00475917
A Study of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Adults With Advanced Malignancies
19 augusti 2015 uppdaterad av: Exelixis
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Subjects With Advanced Malignancies
The purpose of this study is to determine a safe dose of XL844 in combination with gemcitabine, how often it should be taken, and how well people with cancer tolerate the combination of gemcitabine and XL844.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
28
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- M.D. Anderson Cancer Center
-
-
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 advanced malignancy (solid tumor or lymphoma) that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known 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 has an ECOG (Eastern Cooperative Oncology Group) performance status of ≤2.
- The subject has adequate organ and marrow function.
- The subject has the capability 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 pregnancy test at screening.
- If a subject has received more than three prior regimens of cytotoxic chemotherapy, more than two biologic regimens, or more than 3000 cGy to >25% of his or her bone marrow, the investigator must discuss with the sponsor regarding subject suitability before 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, and has had no evidence of disease for 5 years prior to screening for this study).
Exclusion Criteria:
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agent, or hormones) within 14 days prior to the first dose of study drug.
- The subject has not recovered to Grade ≤1 from adverse events (AEs) due to investigational agents or other medications administered more than 30 days prior to the first dose of study drug.
- The subject has received radiation to >25% of his or her bone marrow within 30 days of XL844 treatment.
- The subject has a primary brain tumor or known brain metastases.
- The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations 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 is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
- The subject has a known allergy or hypersensitivity to any of the components of the XL844 formulation or gemcitabine.
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 |
---|---|
Experimentell: 1
|
Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing.
once-weekly 30-minute IV infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Safety and tolerability of XL844 as a single agent and in combination with gemcitabine when administered orally to subjects with advanced malignancies
Tidsram: Assessed at each visit/periodic visits
|
Assessed at each visit/periodic visits
|
Determine the Combination maximum tolerated dose and dose-limiting toxicities for XL844 alone and in combination with gemcitabine
Tidsram: Assessed at periodic visits
|
Assessed at periodic visits
|
Evaluate plasma pharmacokinetics and estimate renal elimination of XL844 as a single agent and in combination with gemcitabine
Tidsram: Assessed at periodic visits
|
Assessed at periodic visits
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
(Exploratory:) Assess tumor response after repeated administration of XL844 in combination with gemcitabine in subjects with advanced malignancies
Tidsram: Assessed at periodic visits
|
Assessed at periodic visits
|
Pharmacodynamic correlates of XL844 activity in tumor tissue
Tidsram: Assessed at periodic visits
|
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 maj 2007
Primärt slutförande (Faktisk)
1 december 2008
Avslutad studie (Faktisk)
1 december 2008
Studieregistreringsdatum
Först inskickad
17 maj 2007
Först inskickad som uppfyllde QC-kriterierna
17 maj 2007
Första postat (Uppskatta)
21 maj 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
- XL844-002
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 XL844
-
ExelixisAvslutadKronisk lymfatisk leukemi | Litet lymfocytiskt lymfomFörenta staterna