L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04203641|
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Biological: L-DOS47 Drug: Doxorubicin||Phase 1 Phase 2|
The Phase Ib part of the study will apply a standard 3 + 3 algorithm for dose escalation to determine the appropriate L-DOS47 maximum tolerated dose to use in combination with doxorubicin for the Phase II part of the study. Patients will be recruited into 3 cohorts where each cohort will receive increasing weekly dose levels of L-DOS47 in combination with a fixed dose of 20 mg/m2 of doxorubicin weekly. The decision for escalation to the next dose level will be made after all patients in a cohort have completed 4 weeks of combination treatment and the safety data have been reviewed by the Safety Review Committee. If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study.
The Phase II part of the study will focus on evaluating preliminary anti-tumor activity, as well as continuing to evaluate safety and tolerability of L-DOS47 in combination with doxorubicin. A further 11 additional patients will be enrolled in this phase of the study, which is designed to ensure patient safety and to detect whether there is a level of anti-tumor activity that would be worth pursuing in a larger clinical trial. Patients will be initiated on the L-DOS47 dose determined in Phase I, in combination with 20 mg/m2 doxorubicin, with tumor marker carbohydrate antigen 19-9 (CA19-9) measurements at each treatment cycle, and radiological assessments every two treatment cycles.
Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Safety will be assessed by reported adverse events (AEs), serious adverse events (SAEs), physical exams, vital signs, Karnofsky Performance Status, electrocardiogram (ECG), echocardiogram (ECHO)/multigated acquisition scan (MUGA), clinical laboratory evaluations (hematology, chemistry, coagulation and urinalysis), and anti-L-DOS47 antibody levels.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||This is an open-label, single arm study that includes an initial three cohort dose escalation phase with 3, 6 and 9 µg/kg of L-DOS47 in combination with doxorubicin.|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 Plus Doxorubicin for the Treatment of Patients With Previously Treated Advanced Pancreatic Cancer|
|Actual Study Start Date :||December 11, 2019|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: L-DOS47 + doxorubicin
Patients will be recruited into escalating dosing cohorts of 3, 6 and 9 µg/kg of L-DOS47, with a minimum of 3 and a maximum of 6 patients per cohort. A fixed dose of intravenous doxorubicin [20 mg/m2/week] will be administered in combination with L-DOS47 across all cohorts.
A treatment cycle will be 28 days, with patients receiving L-DOS47 on Days 1, 8, 15, and 22.
A treatment cycle will be 28 days, with patients receiving doxorubicin on Days 2, 9, 16 and 23
- Number of complete plus partial responders as per RECIST version 1.1 [ Time Frame: 24 weeks ]Assess number of complete plus partial responders according to RECIST version 1.1 as a measure of preliminary anti-tumor activity of L-DOS47 in combination with doxorubicin
- Adverse events (as per CTCAE v. 5.0) [ Time Frame: 24 weeks ]Assess frequency of treatment emergent adverse events as per Common Terminology Criteria for Adverse Events (CTCAE) v. 5 as a measure of safety and tolerability of L-DOS47 in combination with doxorubicin
- Change in tumor pH [ Time Frame: From screening to end of Cycle 2, where each treatment cycle is 28 days. ]Change from screening tumor pH as measured by SUV on fluorodeoxyglucose-positron emission tomography scan (FDG-PET) scan
- Carbohydrate antigen (CA) 19-9 biomarker level [ Time Frame: Up to 24 weeks ]Change from screening in CA19-9 biomarker levels
- Proportion of patients expressing anti-L-DOS47 antibodies [ Time Frame: Up to 24 weeks ]Assess number of patients expressing anti-L-DOS47 antibodies levels as a measure of
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): NCT04203641
|Contact: Heman Chao, Ph.D.||905-841-2300 ext email@example.com|
|Contact: Brenda Lee, M.Sc.||firstname.lastname@example.org|
|United States, Arizona|
|Scottsdale Healthcare Hospitals DBA HonorHealth||Recruiting|
|Scottsdale, Arizona, United States, 85260|
|Contact: Erkut Borazanci, MD|
|Contact: Joyce Schaffer, RN 480-323-1364 email@example.com|
|United States, New Jersey|
|Atlantic Health System, Morristown Medical Center||Recruiting|
|Morristown, New Jersey, United States, 07962|
|Contact: Nancy Ginder, BSN, OCN 973-971-6608 firstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert Hospital and the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: General Cancer Center Information 866-680-0505 ext 8900 email@example.com|
|Principal Investigator:||Erkut Borazanci, MD||Scottsdale Healthcare Hospitals DBA HonorHealth|