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A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
A Phase 1 Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.
Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-59R5 every week until disease progression.
Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects experiencing a DLT.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan Comprehensive Cancer Center
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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- South Texas Accelerated Research Therapeutics
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.
- Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C.
- Age >18 years
- ECOG performance status <2 (see Appendix B)
- Life expectancy of more than 3 months
Subjects must have normal organ and marrow function as defined below:
- Absolute neutrophil count >1000/mL
- Hemoglobin >9.0 g/dL
- Platelets >100,000/mL
- Total bilirubin <1.5 X institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) < 3 X institutional ULN (for subjects with hepatic metastases < 5 X institutional ULN)
- PT and PTT within 1.5 X institutional ULN
- Creatinine <1.5 X institutional ULN OR
- Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
- Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Subjects receiving any other investigational agents
- Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women or nursing women
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
- Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
- New York Heart Association Classification II, III, or IV
- Subjects with a blood pressure of >140/90 mmHg. The blood pressure must be taken three times 10 minutes apart. Subjects taking antihypertensive medications must be taking ≤ 2 medications to obtain this level of blood pressure control.
- Subjects with EKG evidence of ischemia or ≥ Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina.
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
- Subjects with >1 grade 1 diarrhea.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: OMP-59R5
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IV infusion
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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To determine the safety of OMP-59R5 in subjects with previously treated solid tumors
Tijdsspanne: continuous
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The number of patients experiencing Adverse Events will be reported.
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continuous
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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To determine the pharmacokinetics of OMP-59R5 in subjects with previously treated solid tumors
Tijdsspanne: First 8 doses and following treatment termination
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The half-life, volume of distribution, and clearance will be determined
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First 8 doses and following treatment termination
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To determine the immunogenicity of OMP-59R5 in subjects with previously treated solid tumors
Tijdsspanne: continuous
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The rate of neutralizing antibodies will be determined
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continuous
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To assess the preliminary efficacy of OMP-59R5 in subjects with previously treated solid tumors
Tijdsspanne: continuous
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The response outcome in patient will be determined
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continuous
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: David C. Smith, MD, University of Michigan
- Hoofdonderzoeker: Anthony W. Tolcher, MD, South Texas Accelerated Research Therapeutics, LLC
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 59R5-001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Vaste tumoren
-
Aadi Bioscience, Inc.WervingGeavanceerde vaste tumor | Tumor | Tumor, solideVerenigde Staten
-
Sorrento Therapeutics, Inc.IngetrokkenVaste tumor | Recidiverende vaste tumor | Refractaire tumor
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Memorial Sloan Kettering Cancer CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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RemeGen Co., Ltd.VoltooidMetastatische vaste tumor | Lokaal geavanceerde vaste tumor | Inoperabele vaste tumorAustralië
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalWerving
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.WervingNeoplasmata | Vaste tumor | Kwaadaardige tumorChina
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Baodong QinWervingRefractaire tumor | Zeldzame tumorChina
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The First Affiliated Hospital of Xiamen UniversityWervingVaste tumor | Tumor | Positron-emissietomografieChina
Klinische onderzoeken op OMP-59R5
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OncoMed Pharmaceuticals, Inc.BeëindigdStadium IV kleincellige longkankerVerenigde Staten
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OncoMed Pharmaceuticals, Inc.VoltooidRecidiverende of refractaire solide tumorenVerenigde Staten
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OncoMed Pharmaceuticals, Inc.VoltooidVaste tumorenVerenigde Staten
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OncoMed Pharmaceuticals, Inc.VoltooidRecidiverende of refractaire lymfoïde maligniteitenVerenigde Staten
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OncoMed Pharmaceuticals, Inc.Novotech (Australia) Pty LimitedVoltooidColorectale kankerAustralië, Nieuw-Zeeland
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OncoMed Pharmaceuticals, Inc.BayerVoltooidVaste tumorenVerenigde Staten
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OncoMed Pharmaceuticals, Inc.BeëindigdUitgezaaide kanker | Lokaal gevorderd maligne neoplasmaVerenigde Staten
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OncoMed Pharmaceuticals, Inc.VoltooidVaste tumorenVerenigde Staten
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M.D. Anderson Cancer CenterVoltooidAdenoïd cystisch carcinoomVerenigde Staten
-
OncoMed Pharmaceuticals, Inc.VoltooidRefractaire vaste tumoren | Gevorderde recidiverende tumorenVerenigde Staten