Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
15. januar 2015 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
34
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85258
- Premiere Oncology of Arizona
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Scottsdale, Arizona, Forente stater, 85255
- Scottsdale Medical Imaging, Ltd.
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California
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Santa Monica,, California, Forente stater, 90404
- Premiere Oncology, A Medical Corporation
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1
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Weekly, intravenous dose
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
Tidsramme: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
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|
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Serum Decay Half-Life (t1/2)
Tidsramme: 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)]
Tidsramme: 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)
Tidsramme: 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)
|
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Apparent Clearance (CL)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
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Baseline (Day 0) up to 42 days after the last dose of study medication
|
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Number of Participants With Anti-CVX-060 Antibodies
Tidsramme: Baseline (Day 0) up to 42 days after last dose
|
Baseline (Day 0) up to 42 days after last dose
|
|
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Number of Samples From Participants With Anti-CVX-060 Antibodies
Tidsramme: Baseline (Day 0) up to 42 days after last dose
|
Baseline (Day 0) up to 42 days after last dose
|
|
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Number of Participants With Best Overall Response (BOR)
Tidsramme: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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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.
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Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
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Samarbeidspartnere og etterforskere
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2008
Primær fullføring (Faktiske)
1. april 2011
Studiet fullført (Faktiske)
1. april 2011
Datoer for studieregistrering
Først innsendt
9. april 2009
Først innsendt som oppfylte QC-kriteriene
9. april 2009
Først lagt ut (Anslag)
10. april 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. januar 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. januar 2015
Sist bekreftet
1. januar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B1131002
- CVX-060-101 (Annen identifikator: Alias Study Number)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .