NCT01364727

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Heather Wakelee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Amrubicin, a synthetic 9-aminoanthracycline, is structurally similar to doxorubicin, but has a different primary mode of action. It acts primarily as an inhibitor of DNA topoisomerase II, exerting its cytotoxic effects by stabilizing a topoisomerase II mediated cleavable complex. This inhibition is significantly more than that seen in doxorubicin, which, in contrast, tends to demonstrate more DNA intercalation than amrubicin. It has not yet been evaluated for use in thymic malignancies, but given its efficacy in NSCLC and small cell lung cancer (SCLC), as well as the known efficacy of other anthracyclines and topoisomerase II inhibitors in first-line thymoma treatment, it warrants study for use in the second line and beyond in refractory or relapsed patients. Unlike doxorubicin, amrubicin has had minimal cardiotoxicity even with ongoing use, which also makes it a promising agent for use in the second line even for patients who have previously been exposed to, and potentially helped by, doxorubicin.

Conditions

• Thymoma
• Thymus Cancer
• Thymic Carcinoma

Interventions

Type	Name	Description
DRUG	Amrubicin	35 mg/m2; IV on days 1-3 each 3 week cycle

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-07-01
• Completion: 2018-12-31
• First posted: 2011-06-02
• Last updated: 2019-04-16
• Results posted: 2017-03-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study