Advanced Cancers Clinical Trial
Official title:
A Phase 1 Trial of Lapatinib in Combination With 1) Sirolimus or 2) Metformin in Advanced Cancer
Verified date | November 2015 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status should be less or equal to 3 4. 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. 5. 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 6. Patients must be able to understand and be willing to sign a written informed consent document 7. Patients with treated brain metastases are allowed in both arms of the study. Exclusion Criteria: 1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. 2. Pregnant or lactating women. 3. History of hypersensitivity to Lapatinib or any component of the formulation. 4. Patients who have malabsorption syndrome 5. Patients with class III or IV congestive heart failure as defined by New York Heart Association functional classification system 6. Patients unwilling or unable to sign informed consent document 7. History of hypersensitivity to Sirolimus or any component of the formulation (for Lapatinib and Sirolimus arm only) 8. History of hypersensitivity to metformin or any component of the formulation (for Lapatinib and Metformin arm only) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of Lapatinib in Combination with Sirolimus or Metformin | MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is less than 33%. | 21 day cycle | Yes |
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