Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00718159
First received: July 16, 2008
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine a safe dose of LY573636-sodium to be given to patients with acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY573636-sodium in acute myeloid leukemia and essential thrombocythemia patients.


Condition Intervention Phase
Acute Myeloid Leukemia
Essential Thrombocythemia
Drug: LY573636-sodium
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of LY573636-sodium in Patients With Essential Thrombocythemia and Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended Phase 2 dose of LY573636-sodium in patients with relapsed or refractory acute myeloid leukemia [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics area under the curve(AUC) [ Time Frame: Cycle 1 and all subsequent cycles. ] [ Designated as safety issue: No ]
  • Number of participants with bone marrow response [ Time Frame: Day 14 and Day 28 for cycle 1 and Day 28 for all subsequent cycles ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, concentration maximum (Cmax) [ Time Frame: Cycle 1 and all subsequent cycles. ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY573636 Drug: LY573636-sodium
Individualized dose is dependent on patient's height, weight, gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Dosing will be done on Day 1 of a 35-day cycle for AML and Day 1 of a 28-day cycle for ET for at least one cycle. A patient may have additional cycles of LY573636 if he or she is receiving benefit from the study drug and does not fulfill any of the criteria for study discontinuation.
Other Name: LY573636

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 thrombocythemia.
  • 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 graft-versus-host disease.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718159

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States, 90095
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aurora, Colorado, United States, 80045
United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baltimore, Maryland, United States, 21287
United States, Nevada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Las Vegas, Nevada, United States, 89135
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00718159     History of Changes
Other Study ID Numbers: 12266, H8K-MC-JZAJ
Study First Received: July 16, 2008
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Acute Myeloid Leukemia
Myeloid Leukemia
Relapsed
Refractory

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Thrombocytosis
Thrombocythemia, Essential
Neoplasms by Histologic Type
Neoplasms
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on September 29, 2014