Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02014844|
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: aldoxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of Aldoxorubicin in Subjects With Unresectable Glioblastoma Whose Tumors Have Progressed Following Prior Treatment With Surgery, Radiation and Temozolomide|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Subjects will receive either 250 mg/m2 or 350 mg/m2 aldoxorubicin IV.
Other Name: INNO-206
- Objective Response Rate (Complete Response and Partial Response) [ Time Frame: up to 6 months ]The study will measure the complete response and partial response rate in these subjects using the RANO Working Group Criteria.
- Safety [ Time Frame: up to 6 months ]The secondary objectives of this study are to evaluate the safety of aldoxorubicin in this population assessed by the frequency and severity of adverse events (AEs, abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram evaluations, ECG results, weight, and the change in performance status as measured by the Karnofsky Performance Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014844
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|Sarcoma Oncology Center|
|Santa Monica, California, United States, 90403|
|United States, Louisiana|
|Ochsner Health System|
|New Orleans, Louisiana, United States, 70115-6969|
|United States, Texas|
|Texas Oncology-Austin Midtown|
|Austin, Texas, United States, 78705|