Symptoms and General Pathology

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Immunologic Factors

AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

ridaforolimus

Frank Haluska, M.D., Ph.D.

The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.

The primary objective of the trial is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies by evaluating the response rates as defined for the individual malignancy categories. Secondary objectives include evaluating time to disease progression, progression-free survival and duration of response; evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573; describing health-related quality of life measurements; and exploring the safety and tolerability of AP23573 at the specified dose level.

Protocol Outline: Open label, non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort. Each patient receives a fixed dose of AP23573 administered intravenously (IV) over 30 minutes daily for five days (QDx5) to be repeated every 2 weeks.

Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)

A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

Ariad Pharmaceuticals

Merck Sharp & Dohme LLC

Heart and Blood Diseases

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Polycythemia

Waldenstrom Macroglobulinemia

Blast Crisis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

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Immunoproliferative Disorders

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Leukemia, B-Cell

Chronic Disease

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Translocation, Genetic

Chromosome Aberrations

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

TAK-901 will be administered via IV infusion over a 3-hour period on Days 1,4,8,11,15,18,22, and 25 of each 28-day cycle.

TAK-901

Medical Monitor

The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in subjects with advanced hematological malignancies, and to further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies.

A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies

Millennium Pharmaceuticals, Inc.

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Leukemia, Myelomonocytic, Acute

Myelodysplastic-Myeloproliferative Diseases

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Myelodysplastic/myeloproliferative Disease

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gleevec administered orally at a pre-determined dose once daily.

400mg orally once daily until disease progression or unacceptable side effects

Imatinib mesylate

Daniel J. DeAngelo, MD, PhD

The purpose of this study is to determine the effects (good and bad) of Gleevec in patients with BCR-negative myeloproliferative disorders including myelofibrosis with myeloid metaplasia and chronic myelomonocytic leukemia.

Gleevec will be administered at a dose of 400 mg orally once daily.

Patients will continue to receive the drug until either drug progression or the development of intolerable side effects.

Patients will be assessed with a complete blood count weekly for the first 8 weeks and will have monthly physical examinations and bone marrow examinations every 3 months.

A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)

A Phase II Study of Gleevec (Imatinib Mesylate) In Patients With BCR-Negative Myeloproliferative Disorders Including Patients With Idiopathic Myelofibrosis With Myeloid Dysplasia or Chronic Myelomonocytic Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)	NCT00086125	Hematologic Mal... Leukemia Myelodysplastic... Myeloid Metapla... Lymphoma	ridaforolimus	18 Years -	Merck Sharp & Dohme LLC
Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)	NCT00086125	Hematologic Mal... Leukemia Myelodysplastic... Myeloid Metapla... Lymphoma	ridaforolimus	18 Years -	Merck Sharp & Dohme LLC
A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies	NCT00807677	Acute Myeloid L... Acute Lymphobla... Chronic Myeloge... Chronic Lymphoc... Multiple Myelom... Waldenstrom's M... Myelodysplastic... Philadelphia Ch... Myeloid Metapla... Myelofibrosis Advanced Polycy... Non-Hodgkins Ly...	TAK-901	18 Years -	Millennium Pharmaceuticals, Inc.
A Study of Gleevec in Patients With Idiopathic Myelofibrosis or Chronic Myelomonocytic Leukemia (CMML)	NCT00136409	Myelofibrosis Myeloid Metapla... Agnogenic Myelo... Chronic Myelomo...	Imatinib mesyla...	18 Years -	Dana-Farber Cancer Institute

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