- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01844583
Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib
Study of the Effect of Esomeprazole or Rifampin on the Pharmacokinetics of Alisertib and Evaluation of the Effect of Alisertib on the QTc Interval in Patients With Advanced Solid Tumors or Lymphomas
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The drug tested in this study is called alisertib. Alisertib is being tested to assess the effect of a proton pump inhibitor and strong metabolic inducer on the PK of a single 50 mg dose of alisertib administered as enteric-coated tablets (ECTs).
The study enrolled 55 patients. Participants received either:
- Esomeprazole 40 mg and Alisertib 50 mg
- Rifampin 600 mg and Alisertib 50 mg
All participants were asked to take one tablet of alisertib either once or twice daily in all cycles. In Cycle 2, participants were asked to take alisertib plus either esomeprazole or rifampin.
This trial was conducted the United States. The overall time to participate in this study was 10 months. Participants made multiple visits to the clinic plus a final visit, 30 days after receiving their last dose of study drug for a follow-up assessment.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Florida
-
Sarasota, Florida, Förenta staterna
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna
-
-
Texas
-
Dallas, Texas, Förenta staterna
-
San Antonio, Texas, Förenta staterna
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Male or female participants 18 years or older
- Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival longer than 3 months from enrollment in the study
- Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
- Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
Exclusion Criteria:
Treatment with any anticancer therapy or any investigational agents within 4 weeks before the first dose of alisertib
- Known hypersensitivity or intolerance to rifampin (for participants considered for the rifampin drug-drug interaction [DDI] group) or to esomeprazole (for participants considered for the esomeprazole DDI group)
- Recurrent nausea and/or vomiting within 14 days before the first dose of alisertib, and known gastrointestinal (GI) abnormality or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib
- Participants requiring treatment with clinically significant enzyme inducers within 14 days before the first dose of alisertib and/or requiring the use of these medications during the study
- A medical condition requiring use of pancreatic enzymes; or daily, chronic, or regular use of proton pump inhibitors (PPI); or histamine (H2) receptor antagonists
- Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices).
- Any cardiovascular condition
- Female participants who are lactating or have a positive serum pregnancy test
Major surgery within the 14 days preceding the first dose of alisertib
- Life-threatening or uncontrolled medical illness unrelated to cancer
- Newly diagnosed or uncontrolled cancer-related central nervous system (CNS) disease
- Autologous stem cell transplant within 3 months
Prior allogeneic bone marrow or other organ transplantation
- Other severe acute or chronic medical or psychiatric condition
- Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
Please note there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Esomeprazole 40 mg + Alisertib 50 mg
Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Esomeprazole, 40 mg, delayed-release capsules, orally, once daily on Days 1 to 10 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles). |
Alisertib tabletter
Andra namn:
Esomeprazol kapslar
|
Experimentell: Rifampin 600 mg + Alisertib 50 mg
Alisertib 50 mg, tablets, orally, once on Day 1, followed by twice daily on Days 4 to 10, followed by a 14-day rest period in Cycle 1. Rifampin 600 mg, capsules, orally, once daily on Days 1 to 10 in Cycle 2 plus alisertib, 50 mg, tablets, orally, once on Day 8, followed by twice daily on Days 11 to 17, followed by a 14-day rest period in Cycle 2. Alisertib 50 mg, tablets, orally, twice daily on Days 1 to 7 beginning with Cycle 3 (21-day cycles) to the end of study (Up to 15 Cycles). |
Alisertib tabletter
Andra namn:
Rifampin kapslar
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Esomeprazole
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Esomeprazole
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence and Absence of Esomeprazole
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Esomeprazole
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Terminal Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Esomeprazole
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm
|
Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Rifampin
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Rifampin
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence or Absence of Rifampin
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Rifampin
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Rifampin
Tidsram: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm
|
Change From the Time-matched Baseline in the Individually Corrected QTc Interval (QTcI)
Tidsram: Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1
|
Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From the Time-matched Baseline in the Fridericia Correction of QTc (QTcF)
Tidsram: Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1
|
Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: From the first dose through 30 days after administration of the last dose of study drug (up to 328 days)
|
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
|
From the first dose through 30 days after administration of the last dose of study drug (up to 328 days)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Gastrointestinala medel
- Antibakteriella medel
- Leprostatiska medel
- Cytokrom P-450 enzyminducerare
- Medel mot magsår
- Protonpumpshämmare
- Cytokrom P-450 CYP3A-inducerare
- Antituberkulära medel
- Antibiotika, Antituberkulära
- Cytokrom P-450 CYP2B6-inducerare
- Cytokrom P-450 CYP2C8 inducerare
- Cytokrom P-450 CYP2C19 inducerare
- Cytokrom P-450 CYP2C9 inducerare
- Rifampin
- Esomeprazol
Andra studie-ID-nummer
- C14015
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 Alisertib
-
Millennium Pharmaceuticals, Inc.AvslutadOvarialt karcinomFörenta staterna
-
Millennium Pharmaceuticals, Inc.AvslutadAvancerade maligniteterSpanien
-
M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.AvslutadLungcancer | MesoteliomFörenta staterna
-
Millennium Pharmaceuticals, Inc.AvslutadAvancerade solida tumörer | LymfomSingapore
-
The University of Texas Health Science Center at...Inte längre tillgängligProstatacancer
-
Millennium Pharmaceuticals, Inc.AvslutadSmåcellig lungcancer | Icke-småcellig lungcancer | Metastaserad bröstcancer | Skivepitelcancer i huvud och nacke | Gastroesofagealt adenokarcinom | Avancerade icke-hematologiska maligniteterFörenta staterna
-
Children's Oncology GroupNational Cancer Institute (NCI)AvslutadNeuroblastom | Ospecificerad fast tumör för barn, exklusive CNS
-
Millennium Pharmaceuticals, Inc.AvslutadLymfom | Avancerade solida tumörerFörenta staterna
-
Millennium Pharmaceuticals, Inc.AvslutadLymfom | Avancerade solida tumörerFörenta staterna
-
Millennium Pharmaceuticals, Inc.AvslutadMultipelt myelom | Waldenströms makroglobulinemi | Anaplastiskt storcelligt lymfom | Angioimmunoblastiskt T-cellslymfom | Diffust stort B-cellslymfom | B-cells kronisk lymfatisk leukemi | Enteropati associerat T-cellslymfom | B-cells follikulärt lymfom | B-cells marginalzon lymfom | B-cells mantelcellslymfom och andra villkorFörenta staterna