Phase 1 Study of LY573636-sodium in Patients With Essential Thrombocythemia and Acute Myeloid Leukemia
- Patients who have a diagnosis of either essential thrombocythemia or acute myeloid
leukemia that is relapsed or refractory to at least one prior standard treatment. If
patients have acute promyelocytic leukemia, they must be resistant and/or intolerant
of both all trans retinoic acid (ATRA) and arsenic trioxide.
- Are at least 18 years of age.
- Have given written informed consent approved by Lilly and the ethical review board
(ERB)/institutional review board (IRB) governing the site.
- Must have adequate hepatic and renal function.
- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, immunotherapy, cancer-related hormonal therapy, or other
investigational therapy for at least 21 days for myelosuppressive agents (such as
cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for
non-myelosuppressive agents prior to receiving study drug and recovered from the
acute effects of therapy. Hydroxyurea used to control peripheral blood blast count is
permitted within these respective periods, but it must be stopped at least 24 hours
before study drug administration.
- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 6 months following the last dose
of study drug.
- Females of child bearing potential must have had a negative serum pregnancy test less
than or equal to 7 days prior to the first dose of study drug.
- Have a serum albumin level greater than equal to 3.0 g/L, less than or equal to 72
hour prior to dosing with LY573636-sodium.
- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of the initial dose of study drug for a
non-myelosuppressive or myelosuppressive agent, respectively.
- Patients with myeloproliferative disorders (for example.chronic myeloid leukemia
(CML), polycythemia vera and primary myelofibrosis) other than essential
- Have received an autologous or allogenic stem cell transplant within 75 days of the
initial dose of study drug for the dose escalation phase or within 60 days of the
initial dose of study drug for the dose confirmation phase. Recipients of an
allogeneic stem cell transplant must have discontinued immunosuppressive therapy at
least 24 hours before study drug administration with no more than Grade 1 acute
- Have previously completed or withdrawn from this study or any other study
investigating LY573636 sodium.
- Have serious preexisting medical conditions that in the opinion of the investigator
would preclude participation in this study.
- Have serious concomitant disorders, including active bacterial, fungal, or viral
infection, incompatible with the study.
- Have a second primary malignancy that could effect interpretation of results.
- Have a known coagulopathy or bleeding disorder, other than leukemic related
thrombocytopenia. Patients with severe or life-threatening bleeding refractory to
platelet transfusions are also excluded from this study.
- Major surgery within 4 weeks of study enrollment.
- Are receiving warfarin (Coumadin).
- Females who are pregnant or breast feeding.
- Have known positive results of HIV, hepatitis B surface antigen (HBSAg) or hepatitis
C antibodies (HCAb).
- Have received treatment within 28 days of the initial dose of study drug with an
experimental agent for noncancer indications that has not received regulatory
approval for any indication.
- Patients receiving amiodarone, quinidine, propofol, or clozapine.
- Patients receiving treatment with strong or moderate inhibitors of cytochrome P450
(CYP)2C19, including proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are
allowed if not administered within 72 hours before or after LY573636 administration