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Lapatinib With Sirolimus or Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01087983
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Lapatinib Drug: Sirolimus Drug: Metformin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Lapatinib in Combination With 1) Sirolimus or 2) Metformin in Advanced Cancer
Study Start Date : March 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lapatinib + Sirolimus
Lapatinib starting oral dose of 500 mg daily for 21 day cycle. Sirolimus starting oral dose 1 mg daily.
Drug: Lapatinib
Starting oral dose of 500 mg daily for 21 day cycle.
Other Names:
  • Tykerb
  • GW572016

Drug: Sirolimus
Starting oral dose 1 mg daily.
Other Name: Rapamune

Experimental: Lapatinib + Metformin
Lapatinib starting oral dose of 500 mg daily for 21 day cycle. Metformin Starting oral dose 1000 mg daily.
Drug: Lapatinib
Starting oral dose of 500 mg daily for 21 day cycle.
Other Names:
  • Tykerb
  • GW572016

Drug: Metformin
Starting oral dose 1000 mg daily.
Other Name: Glucophage

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Lapatinib in Combination with Sirolimus or Metformin [ Time Frame: 21 day cycle ]
    MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is less than 33%.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01087983

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Filip Janku, MD, PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01087983    
Other Study ID Numbers: 2009-0743
NCI-2011-00563 ( Registry Identifier: NCI CTRP )
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by M.D. Anderson Cancer Center:
Metastatic cancer
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action