Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
15 januari 2015 uppdaterad av: Pfizer
A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
34
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Scottsdale, Arizona, Förenta staterna, 85258
- Premiere Oncology of Arizona
-
Scottsdale, Arizona, Förenta staterna, 85255
- Scottsdale Medical Imaging, Ltd.
-
-
California
-
Santa Monica,, California, Förenta staterna, 90404
- Premiere Oncology, A Medical Corporation
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase 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:
- Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- Adequate coagulation, liver, and renal function.
- Candidate for DCE-MRI evaluations.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Exclusion Criteria:
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
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
|
Weekly, intravenous dose
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Tidsram: Baseline (Day 0) up to 30 days after last dose of study medication
|
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Relatedness to CVX-060 was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category were counted once within the category.
|
Baseline (Day 0) up to 30 days after last dose of study medication
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
Tidsram: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
|
Serum Decay Half-Life (t1/2)
Tidsram: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
Tidsram: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
Apparent Volume of Distribution (Vss)
Tidsram: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
Apparent Clearance (CL)
Tidsram: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).
Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax)
Tidsram: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
|
|
|
Recommended Phase 2 Dose (RP2D): Stage 1
Tidsram: Baseline (Day 0) up to 42 days after the last dose of study medication
|
RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings.
DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
|
Baseline (Day 0) up to 42 days after the last dose of study medication
|
|
Number of Participants With Anti-CVX-060 Antibodies
Tidsram: Baseline (Day 0) up to 42 days after last dose
|
Baseline (Day 0) up to 42 days after last dose
|
|
|
Number of Samples From Participants With Anti-CVX-060 Antibodies
Tidsram: Baseline (Day 0) up to 42 days after last dose
|
Baseline (Day 0) up to 42 days after last dose
|
|
|
Number of Participants With Best Overall Response (BOR)
Tidsram: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
|
BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): disappearance of all lesions.
Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions.
PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions.
Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start.
CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response.
SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks.
Participants with >=3 treatments cycles were reported.
|
Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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 januari 2008
Primärt slutförande (Faktisk)
1 april 2011
Avslutad studie (Faktisk)
1 april 2011
Studieregistreringsdatum
Först inskickad
9 april 2009
Först inskickad som uppfyllde QC-kriterierna
9 april 2009
Första postat (Uppskatta)
10 april 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 januari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 januari 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B1131002
- CVX-060-101 (Annan identifierare: Alias Study Number)
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 .