Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT01337505|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : February 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumour||Drug: INNO-206||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2012|
INNO-206 at dosages of 230, 350, and 450 mg/m2 doxorubicin equivalents of 165, 260, and 325 mg/m2)will be administered as a 30 minute IVI on Day 1 of each cycle.
INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.
Other Name: DOXO-EMCH
- Safety [ Time Frame: Up to 6 cycles (every 21 days) ]Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count <25,000/uL or a neutrophil count <500/uL lasting >7 days and/or associated with fever >38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately below will be identified as the MTD.
- Objective response rate [ Time Frame: Up to 6 cycles (every 21 days) ]To evaluate the objective response reate (OR; RECIST 1.1 criteria). Changes in tumor measurements from baseline values that are confirmed by repeat assessments will be assigned a status of CR or PR. OR=CR+PR.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337505
|United States, California|
|Sarcoma Oncology Center|
|Santa Monica, California, United States, 90403|
|Principal Investigator:||Sant Chawla, M.D.||Sarcoma Oncology Center|