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A Phase I Study of the HER1, HER2 Dual Kinase Inhibitor, Lapatinib Plus the Proteosomal Inhibitor Bortezomib in Patients With Advanced Malignancies


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

Thank you

Trial Information

A Phase I Study of the HER1, HER2 Dual Kinase Inhibitor, Lapatinib Plus the Proteosomal Inhibitor Bortezomib in Patients With Advanced Malignancies


Inclusion Criteria:



- Histologically proven malignant solid tumor with measurable disease

- Progression on, or intolerance of, or ineligibility for all standard therapies

- Biopsy accessible tumor deposits

- LVEF >/= institutional normal

- Corrected QT interval less than 500 milliseconds by EKG

- ECOG performance status 0-2

- Subjects with no brain metastases or a history of previously treated brain metastases
who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior
to enrollment and have a baseline MRI that shows no evidence of active intercranial
disease and have not had treatment with steroids within 1 week of enrollment.

- Adequate hepatic, bone marrow, and renal function

- Partial thromboplastin time must be range and INR < 1.5. Subjects on anticoagulants will be permitted to enroll as long
as the INR is in the acceptable therapeutic range.

- Life expectancy > 12 weeks

- Women of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of treatment and/or postmenopausal women must be amenorrheic
for at least 12 months.

- Subject is capable of understanding and complying with parameters as outlines in the
protocol and able to sign and date the informed consent form.

Exclusion Criteria:

- Patients with lymphomas

- CNS metastases which do not meet the criteria outlines in the inclusion criteria

- Peripheral neuropathy >/= Grade 2 at baseline or peripheral neuropathy >/= Grade 1
with neuropathic pain

- Active severe infection or known chronic infection with HIV or hepatitis B virus

- Cardiovascular disease problems including unstable angina, therapy for
life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or
congestive heart failure within the last 6 months

- Life-threatening visceral disease or other severe concurrent disease

- Women who are pregnant or breastfeeding

- Anticipated patient survival under 3 months

- Concurrent use of known CYP 3A4 inhibiting or activating medications

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Description:

The highest dose at which

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Michael Pishvaian, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

2010-533

NCT ID:

NCT01497626

Start Date:

September 2011

Completion Date:

December 2015

Related Keywords:

  • Advanced Solid Tumors
  • Advanced cancer
  • Solid tumor

Name

Location

Georgetown Lombardi Comprehensive Cancer CenterWashington, District of Columbia  20007