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

Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283439
• Other study ID #: 20050144
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 26, 2006
• Last updated: June 16, 2011
• Start date: October 2005
• Est. completion date: September 2008

Study information

• Verified date: June 2011
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapy-Induced Thrombocytopenia
• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Oncology
• Thrombocytopenia
• Thrombocytosis

Intervention

Biological:
• AMG 531
Planned Cohorts: 100 mcg, 300 mcg, 700 mcg, 1000 mcg; Optional Cohorts: cohort expansion, schedule change, new dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Platelet Nadir	Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.	32 weeks	No
Secondary	Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia	Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)	32 weeks	No
Secondary	Duration of Grade 3 or 4 Thrombocytopenia	Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)	32 weeks	No
Secondary	Percentage of Subjects That Received Platelet Transfusions	Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle	32 weeks	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling