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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01021072
Other study ID # 2009-PT004
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 31, 2010
Est. completion date August 31, 2013

Study information

Verified date February 2021
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process. An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 31, 2013
Est. primary completion date October 31, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MABp1
0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.

Locations

Country Name City State
United States M.D. Anderson Cancer Institute Houston Texas
United States MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose one year
Secondary Tumor response one year
Secondary Cachexia Response Change in LBT as measured by DEXA 8 weeks
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