Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01021072
First received: November 16, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Advanced Cancers
Drug: MABp1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MABp1 in Patients With Advanced Cancers

Resource links provided by NLM:


Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Cachexia Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in LBT as measured by DEXA


Enrollment: 52
Study Start Date: March 2010
Study Completion Date: August 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MTD
The study will utilize a standard 3+3 design for dose escalation. Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021072

Locations
United States, Texas
M.D. Anderson Cancer Institute
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
XBiotech, Inc.
  More Information

No publications provided by XBiotech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01021072     History of Changes
Other Study ID Numbers: 2009-PT004
Study First Received: November 16, 2009
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014