Source: http://clinicaltrials.keckmedicine.org/clinicaltrials/134?zip_code=90033
Timestamp: 2017-06-25 22:31:26
Document Index: 245988180

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 1', 'art 2', 'art 3', 'art 4', 'arts 1', 'art 2', 'arts 1']

9L-14-1: A multi-center, open-label, phase 1/1b Study of escalating doses of RO5503781 Administered orally as 1) a single Agent, 2) in combination with cytarabine, Or 3) with cytarabine and anthracycline In patients with acute myelogenous Leukemia (AML)
This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of
escalating doses of RO5503781 as a single agent or in combination with cytarabine in
participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in
escalating doses as a single agent, and in Part 2, RO5503781 will be administered in
combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with
cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic
profile of an optimized formulation of RO5503781 in combination with cytarabine will be
Documented/confirmed acute myelogenous leukemia (AML), except for acute promyelocytic leukemiaEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 in Part 1 and Part 2, participants enrolled in the extension/tail portion, Part 3 and Part 4 must have an ECOG performance status of 0 or 1All non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (Adequate hepatic and renal functionWilling to submit the blood sampling and bone marrow sampling required by protocol Additional inclusion criteria for Parts 1-4 may apply.
Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea as defined in protocolHistory of allergic or toxic reactions attributed to cytarabine (Part 2) or history of allergic reactions to components of the formulated productCurrent evidence of central nervous system (CNS) leukemiaParticipants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the studyParticipants with evidence of electrolyte imbalance greater than or equal to (>/=) Grade 2 which cannot be corrected prior to study initiationPregnant or breastfeeding womenHuman immunodeficiency virus (HIV)positive participants receiving anti-retroviral therapyParticipants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products Additional exclusion criteria for Parts 1-4 may apply.
Unknown facility, San Antonio, Texas, 78229