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Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

Phase 1/Phase 2
18 Years
Not Enrolling
Solid Tumors, Advanced Cancer

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Trial Information

Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

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

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

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 M. D. Anderson.

Inclusion Criteria:

1. Patients with a diagnosis of solid tumors who are at high risk for
chemotherapy-induced severe thrombocytopenia related to the following regimens: (a)
Carboplatin (AUC=11); (b) AI regimen (adriamycin 75-90mg/m2, Ifosfamide 10gm/m2); (c)
High dose Ifosfamide (14gm/m2)

2. Age >/= 18 years.

3. Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100 x 10^9/L and Hgb >/=
8 gm/dL), renal (serum creatinine bilirubin normal range).

4. Karnofsky Performance Status >/= 80

5. Signed informed consent form

6. Patients with childbearing potential (defined as not post-menopausal for 12 months or
no previous surgical sterilization) must have a negative pregnancy test and use
adequate birth control. [i.e. oral contraceptives, spermicide with either a condom,
diaphragm or cervical cap, use of an intrauterine device (IUD), or abstinence].

Exclusion Criteria:

1. Patients with rapidly progressive disease (such as patients with rapidly accumulating
ascites or pleural effusion).

2. Patients with hematologic malignancies.

3. Pregnant or lactating women.

4. History of CNS metastasis.

5. Patients with significant cardiac disease (NYHA Class III or IV), dysrrhythmia, or
recent history of MI or ischemia, transient ischemic attack or CVA within the
previous 6 months of study entry.

6. Patients with a history of thromboembolic events (history of DVT or pulmonary

7. Prior chemotherapy, immunotherapy, or experimental drug (not FDA-approved drug)
within 3 weeks. Patients will be eligible if day 1 of chemotherapy was initiated 3
weeks prior to study entry if the patient has recovery of blood counts and from acute
toxicity of chemotherapy as described in inclusion criteria # 3.

8. Use of nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks of study entry.

9. Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry.

10. Patients with history of prior whole pelvic radiation will be excluded unless there
is no prior history of severe thrombocytopenia (i.e. platelet nadir <10,000/mm^3)

11. Patients with history of prior high dose chemotherapy with stem cell transplant or
with history of prolonged thrombocytopenia (>/= 2 weeks).

12. History of any platelet disorders including ITP, TTP or bleeding disorders.

13. History of > 4 prior chemotherapy regimens (all platinum regimens will be counted as
one regimen).

14. Patients with significant bowel dysfunction secondary to tumor (significant abdominal
pain with severe constipation/diarrhea (>/= Grade 3), significant difficulty
maintaining oral nutrition).

15. Patients with pre-existing neuropathy > Grade 2.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Maximum Tolerated Dose of AMG 531

Outcome Time Frame:

Toxicity assessments with each dose level/cycle (21-28 day cycle)

Safety Issue:


Principal Investigator

Saroj Vadhan-Raj, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

Related Keywords:

  • Solid Tumors
  • Advanced Cancer
  • Advanced Cancer
  • Advanced Malignancy
  • Solid Tumors
  • Thrombocytopenia
  • AMG 531
  • Romiplostim
  • Carboplatin
  • Paraplatin
  • Platelets
  • Adriamycin
  • Doxorubicin
  • Rubex
  • Ifosfamide
  • Ifex
  • Neoplasms



U.T.M.D. Anderson Cancer Center Houston, Texas  77030