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

Advanced Cancers Clinical Trial

Official title:

A Phase 1 Study of MABp1 in Patients With Advanced Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021072
• Other study ID #: 2009-PT004
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Advanced Cancers
• Neoplasms

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