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A Phase 1 Study of MABp1 in Patients With Advanced Cancers


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancers

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Trial Information

A Phase 1 Study of MABp1 in Patients With Advanced Cancers


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

one year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2009-PT004

NCT ID:

NCT01021072

Start Date:

March 2010

Completion Date:

January 2013

Related Keywords:

  • Advanced Cancers
  • Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
M.D. Anderson Cancer InstituteHouston, Texas  77030