Phase 2
N=55
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Solid Tumors · Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00147225 ↗Enrolled (actual)
55
Serious AEs
5.9%
Results posted
May 2014
Primary outcome: Primary: Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy — 0; 0; 1; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMG 531 (Drug); Carboplatin (Drug); Adriamycin (Drug); Ifosfamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy |
0; 0; 1; 4; 5; 8 | — |
| PRIMARY Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy |
0; 0; 1; 0; 1; 0 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- 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)
- Age >/= 18 years.
- Adequate hematologic (Absolute neutrophil count (ANC) >/= 1500/mm^3, platelet count >/= 100 x 10^9/L and Hgb >/= 8 gm/dL), renal (serum creatinine /= 80
- Signed informed consent form
- 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
- Patients with rapidly progressive disease (such as patients with rapidly accumulating ascites or pleural effusion).
- Patients with hematologic malignancies.
- Pregnant or lactating women.
- History of central nervous system (CNS) metastasis.
- Patients with significant cardiac disease (New York Hearth Association (NYHA) Class III or IV), dysrrhythmia, or recent history of MI or ischemia, transient ischemic attack or cerebrovascular accident (CVA), within the previous 6 months of study entry.
- Patients with a history of thromboembolic events (history of deep venous thrombosis (DVT) or pulmonary embolus).
- 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.
- Use of nitrosourea (carmustine (BCNU), lomustine (CCNU) or mitomycin - C within 6 weeks of study entry.
- Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry.
- Patients with history of prior whole pelvic radiation will be excluded unless there is no prior history of severe thrombocytopenia (i.e. platelet nadir /= 2 weeks).
- History of any platelet disorders including Idiopathic thrombocytopenic purpura (ITP), Thrombotic thrombocytopenic purpura (TTP) or bleeding disorders.
- History of > 4 prior chemotherapy regimens (all platinum regimens will be counted as one regimen).
- Patients with significant bowel dysfunction secondary to tumor (significant abdominal pain with severe constipation/diarrhea (>/= Grade 3), significant difficulty maintaining oral nutrition).
- Patients with pre-existing neuropathy > Grade 2.
Data sourced from ClinicalTrials.gov (NCT00147225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.