ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT03449901|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: pegylated arginine deiminase Drug: Gemcitabine Drug: Docetaxel Procedure: Tumor biopsy Procedure: Research blood draw||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma|
|Actual Study Start Date :||May 9, 2018|
|Estimated Primary Completion Date :||May 9, 2020|
|Estimated Study Completion Date :||February 9, 2025|
Experimental: ADI-PEG 20 + Gemcitabine + Docetaxel
Drug: pegylated arginine deiminase
-Arginine deiminase (ADI) is a recombinant protein cloned from M. hominis, produced in E. coli, and conjugated with PEG of 20,000 mw using a succinimidyl succinate linker. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.
Other Name: ADI-PEG 20
-Gemcitabine is a nucleoside metabolic inhibitor that exhibits antitumor activity.
Other Name: Gemzar
-Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants.
Other Name: Taxotere
Procedure: Tumor biopsy
Procedure: Research blood draw
-Day -7 (pre-treatment), Day -1, and Days 1 and 8 of each cycle
- Progression-free survival (PFS) [ Time Frame: Through completion of follow-up (median treatment of 9 months + 6 months of follow-up) ]
- PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet
- Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- Overall survival (OS) [ Time Frame: Through 5 years after completion of treatment (median treatment of 9 months) ]-OS: defined as time on study to time of death due to any reasons or latest follow-up (whichever is earlier)
- Clinical benefit rate (CBR) [ Time Frame: Through completion of treatment (median treatment of 9 months) ]
- CBR = proportion of patients who have experienced complete response (CR)+ partial response (PR) + stable disease (SD) lasting 24 weeks or longer
- CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
- PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Safety and tolerability of regimen as measured by number and grade of adverse events [ Time Frame: From start of treatment through 30 days after completion of treatment (median treatment of 9 months + 1 month follow-up) ]-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
- Cancer-related mortality [ Time Frame: Through 5 years after completion of treatment (median treatment of 9 months) ]
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): NCT03449901
|Contact: Brian A Van Tine, M.D., Ph.D.||firstname.lastname@example.org|
|United States, California|
|Sarcoma Oncology Center||Not yet recruiting|
|Santa Monica, California, United States, 90403|
|Contact: Sant P Chawla, M.D. 310-552-9999|
|Principal Investigator: Sant P Chawla, M.D.|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Brian A Van Tine, M.D., Ph.D. 314-362-5817 email@example.com|
|Principal Investigator: Brian A Van Tine, M.D., Ph.D.|
|Sub-Investigator: Douglas Adkins, M.D.|
|Sub-Investigator: Angie Hirbe, M.D.|
|Sub-Investigator: Jingqin (Rosy) Luo, Ph.D.|
|Principal Investigator:||Brian A Van Tine, M.D., Ph.D.||Washington University School of Medicine|