Solid Tumors Clinical Trial
Official title:
Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
The goal of this clinical research study is to find the highest safe dose of AMG 531 that
will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients
who have received chemotherapy. Researchers will also look at the safety and effectiveness
of AMG 531 (Romiplostim).
Primary Objectives:
1. To determine the clinical safety and tolerability of AMG 531 administered following
chemotherapy in patients with advanced malignancy
2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients
receiving chemotherapy known to cause severe thrombocytopenia
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and
platelet recovery following chemotherapy
Secondary Objective:
1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route
post-chemotherapy
Platelets are cells that help make the blood clot. A decrease in platelets can cause
bleeding, which may prevent or delay a patient from receiving chemotherapy. Researchers want
to find out if AMG 531 can lower the risk and severity of this side effect. AMG 531 is a
protein that stimulates platelet production.
If you are eligible to take part in this study, you will be assigned to 1 of 6 dosing
schedules of study drug. The dose of AMG 531 that you receive will depend on when you are
enrolled.
In Cycle 1, all patients will receive chemotherapy by itself. Three (3) weeks later, in
Cycle 2, the same dose of chemotherapy will be given followed by AMG 531. AMG 531 will be
given on one of 3 schedules. AMG 531 will be given as an injection under the skin on the day
after chemotherapy and 2 days later; it will be given 5 days before and the day after
chemotherapy; or it will be given 5 and 3 days before chemotherapy and on the day after
chemotherapy and 2 days later. The schedule you receive will depend on when you enroll on
the study. After 2 cycles of treatment, based on response of the disease and tolerance to
the treatment, all participants may be able to receive up to 4 more cycles of chemotherapy
followed by AMG 531. All participants will continue on the same schedule you were receiving
before. The dose of AMG 531 may be increased at one time point during the study based on the
response of the platelet counts.
The number of blood tests drawn (about 3 teaspoons each) will depend on your clinical
condition. These samples will be taken at least 2 times a week and as often as once a day
during portions of the study. You will also have blood (about 1 teaspoon) collected for the
evaluation of anti-AMG 531 antibody status before treatment starts, at the end of Cycles 2
and 4, and at the end of study.
You will be taken off the study if your disease gets worse or intolerable side effects
occur. At the end of the study, you will have a medical history and physical exam, including
measurement of vital signs. You will also have blood (about 1 teaspoon) drawn for routine
tests.
This is an investigational study. AMG 531 is not FDA approved or commercially available. At
this time, it is being used for research purposes only. Up to 56 patients will take part in
this study. All will be enrolled at University of Texas (UT)MD Anderson.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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