MDACC Study Summary 2005-0577 (Archived)

Study Summary
No. 2005-0577:.......Hematologic Disorder; Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2005-0577

Study Title:	An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Subjects with Thrombocytopenia and Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Physician

New Patient Referral



Name:	Hagop Kantarjian	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7026 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Weekly for 4 weeks, or 39 weeks if enrolled in the extension arm, then every 3-4 weeks for 2 months.

Treatment Agents:	AMG 531	Home Care:	NA

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to find a safe dose of AMG 531 that can be given as an effective treatment of low platelet count in patients with low or intermediate-1 risk MDS. The safety and effectiveness of this drug and how it behaves in the body will also be studied.

Study Objectives / Outcomes

Primary Objective: To evaluate the safety and tolerability of AMG 531 in thrombocytopenic subjects with low or Intermediate-1 risk MDS.

Secondary Objective(s):
Part A: To evaluate the platelet response of thrombocytopenic subjects with low or intermediate-1 risk MDS receiving AMG 531.

Part B: To assess the pharmacodynamics (PD) and pharmacokinetics (PK) of three dosing schedules of AMG 531 administered via subcutaneous or intra-venous administration in thrombocytopenic subjects with MDS.

Study Status Information



Study Activation / Registration Date:	03/08/2006

IRB Review and Approval Date:	02/01/2006

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	45-95

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Disease related: Diagnosis of MDS using the World Health Organization classification.

2) Low or Intermediate-1 risk MDS using the IPSS.

3) The mean of two platelet counts taken during the screening period must be </= 50 x 10^9/L, with no individual count > 55 x 10^9/L (5 patients enrolled at the MTD must be </= 20 x 10^9/L). Standard of care platelet assessments taken prior to Informed Consent may be included in this average if taken within 3 weeks prior to study day 1.

4) Demographic: Subjects must be >/= 18 years of age at the time of obtaining informed consent.

5) Eastern Cooperative Oncology Group (ECOG) perfromance status of 0-2 at the time of screening.

6) Laboratory: Adequate liver function, as evidenced by a serum bilirubin </= 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilbert's Disease), ALT </= 3 times the laboratory normal range, and AST </= 3 times the laboratory normal range.

7) A serum creatinine concentration </= 2 mg/dL (</= 176.6 mu mol/L).

8) Ethical: Before any study specific procedure the appropriate written informed consent must be obtained.

Exclusion Criteria:

1) Disease related: Currently receiving any treatment for MDS other than transfusions and erythropoietic growth factors. If granulocyte growth factors are currently being received, they cannot be used on or after study day 1.

2) Clinically significant bleeding within 2 weeks prior to screening (eg, GI bleeds, intracranial hemorrhage).

3) Prior malignancy (other than controlled prostate cancer, in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for >/= 3 years before screening.

4) Prior history of bone marrow transplantation.

5) Persistent peripheral blood monocytosis (>/= 3 months with an absolute monocyte count > 1,000/mu L).

6) Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or a recent (within 1 year) myocardial infarction.

7) Medications: Received anti-thymocyte globuline (ATG) within 6 months of screening.

8) Received hypomethylating agents, immunomodulating agents, histone deacetylase inhibitors, cyclosporine or mycophenolate within 6 weeks of screening.

9) Received IL-11 (oprelvekin) within 4 weeks before screening.

10) Concurrent use of granulocyte growth factors (i.e. G-CSF(Neupogen�, Granocyte�), pegfilgrastim (Neulasta�), GM-CSF (Leukine, Prokine, Sargramostim)).

11) Have ever previously received rTPO, PEG-rHuMGDF, eltrombopag, or AMG 531.

12) Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication.

13) General: Other investigational procedures are excluded.

14) History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year.

15) History of venous thrombosis that currently requires anti-coagulation therapy.

16) Untreated B12 or folate deficiency.

17) Subject is evidently pregnant (eg, positive HCG test) or is breast feeding.

18) Subject is not using adequate contraceptive precautions.

19) Subject has known hypersensitivity to any recombinant E coli-derived product.

20) Subject previously has enrolled in this study.

21) Subject will not be available for follow-up assessment.

22) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Links

Registration Number: NCT00303472
Study Information on Clinical Trials Registry (clinicaltrials.gov)