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- Ensaio Clínico NCT01778439
A Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors
A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94115
- University of California, San Francisco/Helen Diller Cancer Institute
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Denver -RCI-South Tower
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Karmanos Cancer Institute (KCI)
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State University/Oncology Karmanos Cancer Institute
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78229
- South Texas Accelerated Research Therapeutics, LLC
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for the study:
- Age >18 years
- ECOG performance status <2 (see Appendix B)
- Solid tumor malignancy for which there is no remaining standard therapy or either refuse or are not considered to be candidates for any remaining standard therapy.
- Must have a tumor that is measurable or evaluable per RECIST v1.1 in the dose escalation phase. In the expansion cohort(s), subjects must have measurable disease.
- Subjects must have Formalin-Fixed, Paraffin-Embedded (FFPE) tissue available either archived or fresh core or punch needle biopsied at study entry (two fresh cores/punches preferred whenever possible) for determination of Notch1 pathway activation status.
- Must have received their last chemotherapy, biologic, radiotherapy, or investigational therapy at least 4 weeks prior to enrollment; 6 weeks if the last regimen included BCNU or mitomycin C.
Subjects must have normal organ and marrow function as defined below:
- Absolute neutrophil count >1500/mL without growth factor support in the past 7 days
- Platelets >100,000/mL without transfusions in the past 7 days
- Total bilirubin <1.5 X institutional upper limit of normal (ULN) (<2X ULN for subjects with Gilbert's syndrome)
- AST (SGOT) and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic involvement <5 X institutional ULN but cannot be associated with elevated bilirubin)
- PT/INR and aPTT 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
- Normal Ejection Fraction (>50%) on ECHO scan or MUGA
- 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 who meet any of the following criteria will not be eligible for participation in the study:
- Currently receiving any therapeutic treatment for their malignancy including other investigational agents
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Uncontrolled seizure disorder, active neurologic disease, or active CNS involvement except for individuals who have previously-treated CNS metastases, are asymptomatic, and have no requirement for higher doses of corticosteroids (> prednisone 10mg orally per day) or anti-seizure medication for at least 4 weeks prior to first dose of study drug.
- History of a Grade 4 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
- Ongoing malignancies or malignancies in remission <3 years other than the malignancies included in this trial. Patients with history of known squamous cell skin cancers within the past 3 years will not be included in this trial. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, and low-grade local bladder cancer.
- Subjects with known HIV infection
- Known bleeding disorder or coagulopathy
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
- Hemoptysis in excess of 2.5 mL(or one-half teaspoon) within 8 weeks of first dose of study drug.
- 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 (see Appendix D)
Subjects with poorly controlled blood pressure (defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) that is not responsive to medical therapy. Subjects taking antihypertensive medications must be taking ≤2 medications to obtain this level of blood pressure control.
NOTE: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry.
- Subjects with ECG 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
- active peptic ulcer disease
- known intraluminal metastatic lesion(s) with risk of bleeding
- history of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
- Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti diarrheal therapy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: OMP-52M51
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Safety profile of OMP-52M51 in subjects with relapsed or refractory solid tumors
Prazo: Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
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Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory solid tumors
Prazo: PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
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Apparent half life, AUC, clearance, volume of distribution
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PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
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Immunogenicity
Prazo: Assessed at baseline, prior to each dose, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
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Assessed at baseline, prior to each dose, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
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Preliminary Efficacy
Prazo: Evaluation for response will be assessed on day 70 of study and every 8 weeks (or 9 weeks for Q3W schedule) thereafter and will be based on RECIST v1.1.
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Evaluation for response will be assessed on day 70 of study and every 8 weeks (or 9 weeks for Q3W schedule) thereafter and will be based on RECIST v1.1.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 52M51-002
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Ensaios clínicos em OMP-52M51
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OncoMed Pharmaceuticals, Inc.ConcluídoNeoplasias Linfóides Recidivantes ou RefratáriasEstados Unidos
-
M.D. Anderson Cancer CenterConcluídoCarcinoma Adenóide CísticoEstados Unidos
-
OncoMed Pharmaceuticals, Inc.ConcluídoCâncer Colorretal MetastáticoEstados Unidos
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OncoMed Pharmaceuticals, Inc.ConcluídoTumores SólidosEstados Unidos
-
OncoMed Pharmaceuticals, Inc.Novotech (Australia) Pty LimitedConcluídoCâncer colorretalAustrália, Nova Zelândia
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OncoMed Pharmaceuticals, Inc.BayerConcluídoTumores SólidosEstados Unidos
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OncoMed Pharmaceuticals, Inc.RescindidoCâncer metastático | Neoplasia maligna localmente avançadaEstados Unidos
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OncoMed Pharmaceuticals, Inc.ConcluídoTumores SólidosEstados Unidos
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OncoMed Pharmaceuticals, Inc.ConcluídoTumores Sólidos Refratários | Tumores Recidivantes AvançadosEstados Unidos
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M.D. Anderson Cancer CenterAtivo, não recrutandoCarcinoma ovariano resistente à platina recorrente | Adenocarcinoma recorrente de células claras das trompas de falópio | Adenocarcinoma recorrente de células claras do ovário | Carcinoma recorrente de tuba uterina resistente à platina | Carcinoma Peritoneal Primário Resistente à Platina Recorrente e outras condiçõesEstados Unidos