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

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00283439

First received: January 26, 2006

Last updated: June 16, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2006

Last Updated Date

June 16, 2011

Start Date ^ICMJE

October 2005

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Platelet Nadir [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

Original Primary Outcome Measures ^ICMJE

Incidence of adverse events including clinically significant changes in laboratory values and change in platelet nadir from the previous qualifying cycle to the first treatment cycle

Change History

Complete list of historical versions of study NCT00283439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)
Duration of Grade 3 or 4 Thrombocytopenia [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
Percentage of Subjects That Received Platelet Transfusions [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

Original Secondary Outcome Measures ^ICMJE

Proportion of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 109/L, and <25 x 109/L), Duration of grade 3 and/or 4 thrombocytopenia (<50 x 109/L, and <25 x 109/L), and proportion of subjects that receive platelet transfusions.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

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

Intervention ^ICMJE

Biological: AMG 531

Planned Cohorts:

100 mcg,
300 mcg,
700 mcg,
1000 mcg;

Optional Cohorts:
cohort expansion,
schedule change,
new dose

Study Arm (s)

Experimental: Single Arm: AMG 531 Dose-Escalating Cohort Study

Intervention: Biological: AMG 531

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00283439

Other Study ID Numbers ^ICMJE

20050144

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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