Lapatinib With Sirolimus or Metformin

Completed · Phase 1

Conditions studied: Advanced Cancers

In brief

The goal of this clinical research study is to find the highest tolerable dose of 2 different combinations of drugs that can be given to patients with advanced cancer. The first combination of drugs is Tykerb (lapatinib) and Rapamune (sirolimus), and the second combination is lapatinib and Glucophage (metformin). The safety of these drug combinations will also be studied.

Key facts

Study ID

NCT01087983

Run by

M.D. Anderson Cancer Center

People needed

111

Starts

2010-03-01

Expected to finish

2015-09-01

Last updated by the study team

2015-11-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
• Patients must be at least 3 weeks beyond their previous cytotoxic treatment. Patient must wait at least 5 half-lives or 3 weeks, whichever is shorter, from their previous targeted or biologic therapy; In addition, patients must be at least 3 weeks beyond the last session of radiation therapy or major surgery. Local palliative radiation therapy that is not delivered to all target lesions is allowed immediately before or during treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status should be less or equal to 3
• Patients must have normal organ and marrow function defined as: absolute neutrophil count (ANC) >/= 750/mL; platelets >/= 50,000/mL; creatinine </= 2x upper limit of normal (ULN) for the Sirolimus Arm and creatinine < 1.5 mg/dl for the Metformin arm; total bilirubin </=2.0 (For patients with Gilbert syndrome, bilirubin level > 2 could will be allowed on study if the hyperbilirubinemia is believed to be secondary only to the Gilbert syndrome); ALT (SGPT) </= 5x ULN; Exception for patients with liver metastasis: total bilirubin </= 3x ULN; ALT (SGPT) </= 8x ULN.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose
• Patients must be able to understand and be willing to sign a written informed consent document
• Patients with treated brain metastases are allowed in both arms of the study.

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
• Pregnant or lactating women.
• History of hypersensitivity to Lapatinib or any component of the formulation.
• Patients who have malabsorption syndrome
• Patients with class III or IV congestive heart failure as defined by New York Heart Association functional classification system
• Patients unwilling or unable to sign informed consent document
• History of hypersensitivity to Sirolimus or any component of the formulation (for Lapatinib and Sirolimus arm only)
• History of hypersensitivity to metformin or any component of the formulation (for Lapatinib and Metformin arm only)

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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