Clinical trial NCT00122343 (phase 2, status: completed)
Conditions: endometrial cancer
ICD codes: N85.00, N85.01, N85.02, N99.85
Drugs: ridaforolimus
SMILES: CO[C@@H]1C[C@H](C[C@@H](C)[C@@H]2CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@@H]3CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@H]3C(=O)O2)OC)CC[C@H]1OP(C)(C)=O
Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years of age with histologically confirmed endometrial cancer

          -  Documented progression of endometrial cancer (e.g., within the last 3 months)

          -  If of childbearing potential, must agree to use approved barrier methods of
             contraception (non hormonal methods)

          -  Presence of at least one measurable lesion that can be accurately measured in at least
             one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm
             with spiral computed tomography (CT) scan (or otherwise at least twice the
             reconstruction interval for CT or magnetic resonance imaging [MRI] scans). Previously
             irradiated lesions may be considered to be measurable provided: *there has been
             documented progression of the lesion(s) since completion of radiotherapy; and *the
             criteria for measurability as outlined above are met.

          -  ECOG performance status ≤ 2

          -  Minimum life expectancy of 3 months

          -  Adequate renal and hepatic function, defined as:

               -  Total serum bilirubin ≤ 1.5 x ULN for the institution;

               -  AST and/or ALT ≤ 2 x ULN for the institution;

               -  Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then
                  alkaline phosphatase liver fraction must be < 1.5 ULN);

               -  Serum albumin ≥ 2.5 g/dL;

               -  Serum creatinine ≤ 1.5 x ULN for the institution.

          -  Adequate bone marrow function, defined as:

               -  ANC ≥ 1.5 x 10^9/L;

               -  Platelet count ≥ 100 x 10^9/L.

          -  Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL

          -  Able to understand and give written informed consent

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Presence of brain metastases

          -  More than 2 prior regimens of cytotoxic chemotherapy or enzyme inhibitor therapy

          -  Prior therapy with rapamycin, rapamycin analogues or tacrolimus; or known sensitivity
             to these agents

          -  Anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response
             modifiers, signal transduction inhibitors, etc.) within 4 weeks prior to the first
             dose of AP23573. The interval may be ≥ 2 weeks for hormonal therapy or signal
             transduction inhibitors with a half-life known to be <24 hours and must be ≥ 6 weeks
             for nitrosourea or mitomycin.

          -  Ongoing toxicity associated with prior anticancer therapy (except peripheral
             neuropathy of ≤ Grade 1 by National Cancer Institute [NCI] toxicity criteria)

          -  Another primary malignancy within the past three years (except for non-melanoma skin
             cancer and cervical carcinoma in situ)

          -  Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or
             any other excipient contained in the study drug

          -  Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin,
             erythromycin, azithromycin)

          -  Significant uncontrolled cardiovascular disease

          -  Active infection requiring systemic therapy

          -  Known HIV infection

          -  Treatment with any investigational agent within 4 weeks prior to the first dose of
             AP23573

          -  Concurrent treatment with immunosuppressive agents other than prescribed
             corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study
             drug. Nasal, ophthalmic, and topical glucocorticoid preparations are allowed as well
             as low dose maintenance steroid therapy for other conditions. Physiologic hormone
             replacement therapy (e.g., thyroid supplementation for thyroid deficiency or oral
             replacement glucocorticoid therapy for adrenal insufficiency) is allowed.

          -  Inadequate recovery from any prior surgical procedure or having undergone any major
             surgical procedure within 2 weeks prior to the first dose of AP23573. Patients who
             have recovered from placement of a central venous access port within 2 weeks of Cycle
             1, Day 1 will be considered eligible.

          -  Presence of any other life-threatening illness or organ system dysfunction which, in
             the opinion of the Investigator, would either compromise the patient's safety or
             interfere with evaluating the safety of the study drug