A First in Man Study of MABp1 in Patients With Advanced Cancers

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 24, 2009

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for \>/= 3 months
• • measurable or non-measurable disease at baseline
• • at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
• • will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
• • age \>/= 18 year, male or female
• • Eastern Cooperative Oncology Group performance status 0,1,or 2
• • Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the low limit of normal.
• • Adequate renal function, defined by serum creating \</= 1.5 x ULN
• • Adequate hepatic function
• • Adequate bone marrow function WOCBP, a negative serum pregnancy test result at screening.
• • WOCBP or men whose sexual partners are WOCBP who are willing to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
• • Signed and dated IRB approved ICF before any protocol specific screening procedures are performed
• Exclusion Criteria:
• • serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy.
• • Uncontrolled or significant cardiovascular diseae
• • dementia or altered mental status that would prohibit the understanding or rendering of informed consent
• • not recovered from the adverse effects of prior therapy at the time of enrollment \</= grade 1
• • symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy
• • received extensive prior radiation therapy to the bone marrow
• • immunocompromised, including subjects know to be infected with HIV
• • history of hypersensitivity to compounds of similar chemical or biologic composition to the antibody women how are pregnant or breastfeeding
• • WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication