A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies

Not Recruiting

Trial ID: NCT01364727


A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for thymic cancers.

Official Title

A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Inclusion Criteria:

   - Histologically or cytologically confirmed invasive or metastatic thymoma or thymic
   carcinoma. Locally invasive disease is acceptable, provided it is not resectable.

   - Previous treatment with at least one prior chemotherapy regimen.

   - Documented progressive disease after the most recent chemotherapy regimen.

   - Presence of measurable disease on imaging within 4 weeks prior to first dose

   - Completion of prior systemic therapy at least 4 weeks prior to first dose.

   - Any prior immunotherapy therapy completed at least 8 weeks prior to first dose.

   - Any prior surgery completed at least 4 weeks prior to first dose, with adequate
   recovered from surgery.

   - Any prior radiation therapy must have no residual toxic effects of therapy. Chest
   radiotherapy with curative intent to the primary disease complex must have been
   completed ≥ 28 days prior to first dose. Cranial radiation must have been completed ≥
   21 days prior to first dose. Radiotherapy to all other areas must have been completed
   ≥ 7 days prior to first dose.

   - Age ≥ 18 years.

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

   - Leukocytes ≥ 3000/mm³

   - Absolute neutrophil count ≥ 1500/mm³

   - Platelets ≥ 100,000/mm³

   - Hemoglobin ≥ 9 g/d

   - Serum bilirubin < 1.5 x institutional upper limit of normal (ULN)

   - Aspartate transaminase (AST) and alanine transaminase (ALT) ratio < 3 x ULN

   - Serum creatinine < 1.5 times institutional upper limit of normal if serum creatinine
   above institutional upper limit of normal, calculated serum creatinine clearance by
   the Cockcroft Gault method > 60 mL/min

   - Left ventricular ejection fraction (LVEF) ≥ 50% by transthoracic echocardiogram (TTE)
   or multiple gated acquisition scan (MUGA)

   - For females of childbearing potential, negative serum pregnancy test within 4 weeks of
   first dose.

   - For males and females of childbearing potential, use of effective contraceptive
   methods during the study.

   - Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

   - Current use, or use within 4 weeks prior to first dose, of any other investigational

   - Known history of allergic reactions attributed to compounds of similar chemical or
   biologic composition to amrubicin.

   - Active malignancy requiring treatment other than thymic malignancy.

   - Pregnant or nursing females due to unknown toxic effects of amrubicin on the
   developing fetus or in breast milk. Should a woman become pregnant or suspect she is
   pregnant while participating in this study, she should inform her treating physician

   - Symptomatic central nervous system metastatic disease. Patients with asymptomatic
   brain metastases allowed. If treated with surgical resection or radiation therapy, the
   patient must be stable for >= 2 weeks after completion of therapy. If the patient is
   on corticosteroids, the dose of corticosteroids, the dose of corticosteroids must have
   been stable for >= 2 weeks prior to first dose of study treatment, or be in the
   process of being tapered.

   - Concurrent severe or uncontrolled medical disease (including but not limited to active
   systemic infection, diabetes, hypertension, coronary artery disease, congestive hear
   failure and mental illness) that in the opinion of the investigator would compromise
   the safety of the patient or compromise the ability of the patient to complete the

   - Known history of seropositive human immunodeficiency virus (HIV) or use of
   immunosuppressive medications for other conditions that would, in the opinion of the
   investigator, increase the risk of serious neutropenic complications.


drug: Amrubicin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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