- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03030287
A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer
A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80045
- University of Colorado, Anschutz Medical Campus
-
-
Florida
-
Tampa, Florida, Forente stater, 33612
- H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center)
-
-
North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Levine Cancer Institute
-
-
Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Stephenson Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- The University of Pennsylvania Health System
-
-
Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Tennessee Oncology, PLLC
-
-
Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas, MD Anderson Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
- Measureable disease per response evaluation criteria (RECIST) v1.1
- Prior bevacizumab
- Age > or = 21 years
- Adequate organ and marrow function
- For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
- Subjects with brain metastases
- Subjects with leptomeningial disease or neoplasms in the last 5 years
- Blood pressure >140/80
- Significant intercurrent illness that will limit the patient's ability to participate in the study
- Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
- Pregnant or nursing women
- New York Heart Association Classification II, III, or IV
- Inability to comply with study and follow up procedure
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: OMP-305B83 plus paclitaxel
|
administrert intravenøst
intravenous (in the vein) infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence of dose limiting toxicities (DLT)
Tidsramme: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
|
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel
|
Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progresjonsfri overlevelse
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
Tidsramme: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel
Tidsramme: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Response Rate assessed by RECIST criteria 1.1
Tidsramme: At 56 day intervals while on treatment, through study completion, an average of 6 months
|
At 56 day intervals while on treatment, through study completion, an average of 6 months
|
Response Rate assessed by CA-125 criteria
Tidsramme: At 28 day intervals while on treatment, through study completion, an average of 6 months
|
At 28 day intervals while on treatment, through study completion, an average of 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Genitale neoplasmer, kvinnelige
- Adnexal sykdommer
- Eggledersykdommer
- Egglederneoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Paklitaksel
- Antistoffer, bispesifikke
Andre studie-ID-numre
- B83-002
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. .
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