A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

NCT ID: NCT00283439

Last Updated: 2011-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-09-30

Brief Summary

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

Conditions

Chemotherapy-Induced Thrombocytopenia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Cancer; Oncology; Thrombocytopenia

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single Arm: AMG 531 Dose-Escalating Cohort Study

Group Type: EXPERIMENTAL

AMG 531

Intervention Type: BIOLOGICAL

Planned Cohorts:

1. 100 mcg,

2. 300 mcg,

3. 700 mcg,

4. 1000 mcg;

Optional Cohorts:

5. cohort expansion,

6. schedule change,

7. new dose

Interventions

AMG 531

Planned Cohorts:

1. 100 mcg,

2. 300 mcg,

3. 700 mcg,

4. 1000 mcg;

Optional Cohorts:

5. cohort expansion,

6. schedule change,

7. new dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed Hodgkin's lymphoma or Non-Hodgkin's lymphoma receiving Q14, Q21, or Q28 day CHOP, ICE, ESHAP, or DHAP chemotherapy; with or without Rituximab
• Has adequate bone marrow function; platelet count > 100 x 10^9/L on the day of initiation of the on study chemotherapy of the next treatment cycle and absolute neutrophil count, ANC > or = 1 x 10^9/L, and hemoglobin > or = 9.5 g/dL
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Has adequate liver function
• must be able to receive the same chemotherapy regimen during the first treatment cycle as was received during the prior qualifying cycle
• must experience Common Terminology Criteria (CTC) grade 3 or 4 thrombocytopenia (platelet count < 50 x 10^9/L) as a result of the chemotherapy administered in the cycle immediately preceding study entry
• has serum creatinine concentration < or = 2 mg/dl

Exclusion Criteria

• More that 1 prior relapse chemotherapy regimen
• Sepsis, disseminated coagulation or any other condition that may exacerbate thrombocytopenia
• Significant bleeding (CTC grade 3 or 4)
• History of thromboembolic disease
• Subjects who are identified by clinical history and/or serological testing to have either acute or chronic hepatitis B or C infection or to be HIV positive
• Use of any nitrosourea or mitomycin-C
• Has received any thrombocytopenic growth factor
• Has received a marrow or peripheral blood stem cell infusion
• Known hypersensitivity to any recombinant E. coli-derived product

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Amgen Inc.

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://www.nplate.com/

FDA-approved Drug Labeling

Other Identifiers

20050144

Identifier Type: -

Identifier Source: org_study_id