A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
|ClinicalTrials.gov Identifier: NCT01364727|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2011
Results First Posted : March 14, 2017
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Thymoma Thymus Cancer Thymic Carcinoma||Drug: Amrubicin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies|
|Study Start Date :||June 2011|
|Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2017|
Amrubicin 35mg/m2 IV days 1-3 every 3 weeks
35 mg/m2; IV on days 1-3 each 3 week cycle
Other Name: Calsed
- Overall Response Rate (ORR) [ Time Frame: 2 years ]
Participants received amrubicin 35 mg/m2 IV days 1 to 3, every 3 weeks, until progression or toxicity.
Tumor response rate was assessed radiographically by the Response Evaluation Criteria In Solid Tumors (RECIST), and the overall response rate (ORR) was expressed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.
RECIST criteria define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:
- CR = Disappearance of all target lesions
- PR = 30% decrease in the sum of the longest diameter of target lesions
- Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions
- Stable disease (SD) = Small changes that do not meet above criteria
- Median Progression-free Survival (PFS) [ Time Frame: 2 years ]Median Progression-free survival in patients with thymic malignancies treated with amrubicin
- Disease Control Rate (DCR) [ Time Frame: 2 years ]
Disease control rate (DCR) is the sum of Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate , and is expressed here as the sum of the Overall Response Rate (ORR = CR + PR) plus the Stable Disease (SD) rate, ORR + SD.
Response was assessed by the RECIST criteria, elaborated above.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364727
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Heather A. Wakelee||Stanford University|