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

June 16, 2011 updated by: Amgen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm: AMG 531 Dose-Escalating Cohort Study
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Platelet Nadir
Time Frame: 32 weeks
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
Time Frame: 32 weeks
Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)
32 weeks
Duration of Grade 3 or 4 Thrombocytopenia
Time Frame: 32 weeks
Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
32 weeks
Percentage of Subjects That Received Platelet Transfusions
Time Frame: 32 weeks
Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Estimate)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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