Trial Title:
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
NCT ID:
NCT05712694
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Leiomyosarcoma
Conditions: Keywords:
Soft Tissue Sarcoma
Arginine
Arginine Deiminase
ADI-PEG 20
Pegargiminase
Leiomyosarcoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a global, multicenter, randomized, double-blind, placebo-controlled,
parallel-group phase 3 trial that will compare the efficacy and safety in subjects with
advanced or metastatic LMS previously treated with an anthracycline.
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
This is a global, multicenter, randomized, double-blind, placebo-controlled,
parallel-group phase 3 trial
Intervention:
Intervention type:
Drug
Intervention name:
ADI PEG20
Description:
Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)
Arm group label:
ADIGemDoc
Other name:
Pegargiminase
Intervention type:
Other
Intervention name:
Placebo
Description:
Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)
Arm group label:
PBOGemDoc
Summary:
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously
treated with an anthracycline.
Detailed description:
This is a global, multicenter, randomized, double-blind, placebo-controlled,
parallel-group phase 3 trial that will compare the efficacy and safety in subjects with
advanced or metastatic LMS previously treated with an anthracycline.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- A subject will be eligible for study participation if he/she meets the following
criteria:
1. Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be
standardly treated with Gem or GemDoc.
2. Determination of LMS subtype: uterine or non-uterine.
3. Measurable disease per RECIST 1.1 (Appendix A), defined as lesions that can be
accurately measured in at least one dimension (longest diameter to be recorded)
as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by
clinical exam.
4. Previous treatment with up to 2 systemic regimens, including at least 1
systemic regimen containing doxorubicin.
5. Treatment > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is
allowed.
6. Age >18 years.
7. Eastern Cooperative Oncology Group (ECOG) performance status of < 1 at
enrollment (Appendix B).
8. Leukocytes ≥ 3,000/mcL.
9. Absolute neutrophil count ≥ 1,500/mcL.
10. Platelets ≥ 100,000/mcL.
11. Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's
Disease)
12. AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
13. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation).
14. Serum uric acid ≤ 8 mg/dL (with or without medication control).
15. QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for
adult women.
16. Subjects and their partners must be asked to use appropriate contraception.
They must agree to use 2 forms of contraception or agree to refrain from
intercourse for the duration of the study and for 35 days after the last dose
of ADI-PEG 20 or for at least 3 months (male subjects) or 6 months (female
subjects) after treatment with gemcitabine, whichever is the longer duration.
17. Ability to understand and willingness to sign the informed consent form.
18. No concurrent investigational drug studies are allowed.
Exclusion Criteria:
- A subject will not be eligible for study participation if he/she meets any of the
exclusion criteria:
1. Subjects with history of another primary cancer, including co-existent second
malignancy, with the exception of: a) curatively resected non-melanoma skin
cancer; b) curatively treated cervical carcinoma in situ; or c) other primary
solid tumor with no known active disease present in the opinion of the
Investigator will not affect subject outcome in the setting of current
diagnosis.
2. Currently receiving other investigational agents.
3. Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated > one year ago in
the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
4. Known brain metastases. Such patients must be excluded from this trial because
of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse
events.
5. History of allergic reactions attributed to compounds of similar chemical or
biologic composition to ADI-PEG 20, Gem, Doc, polysorbate 80, pegylated
compounds, or other agents used in this study.
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements.
7. History of seizure disorder not related to underlying cancer.
8. Grade 2 or higher neuropathy.
9. Pregnant and/or breastfeeding. Women of childbearing potential must have a
negative pregnancy test within 14 days of study entry.
10. Known HIV-positivity on combination antiretroviral therapy because of the
potential for pharmacokinetic interactions with the study treatment. In
addition, these patients are at increased risk of lethal infections when
treated with marrow-suppressive therapy. Appropriate studies will be undertaken
in patients receiving combination antiretroviral therapy when indicated.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Cancer Center/ CU Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Breelyn Wilky, MD
Phone:
720-848-0300
Email:
BREELYN.WILKY@cuanschutz.edu
Investigator:
Last name:
Breelyn Wilky, MD
Email:
Principal Investigator
Facility:
Name:
University of Miami/ Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emily Jonczak, MD
Phone:
305-243-2581
Email:
emily.jonczak@med.miami.edu
Investigator:
Last name:
Emily Jonczak, MD
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mihaela Druta, MD
Phone:
813-745-3242
Email:
mihaela.druta@moffitt.org
Investigator:
Last name:
Mihaela Druta, MD
Email:
Principal Investigator
Facility:
Name:
Northwestern
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Seth Pollack, MD
Phone:
312-695-1300
Email:
seth.pollack@northwestern.edu
Investigator:
Last name:
Seth Pollack, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samantha Armstrong, MD
Phone:
317-278-2686
Email:
saaarmst@iu.edu
Investigator:
Last name:
Samantha Armstrong, MD
Email:
Principal Investigator
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Rieth, MD
Phone:
319-356-2324
Email:
john-rieth@uiowa.edu
Investigator:
Last name:
John Rieth, MD
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rashmi Chugh, MD
Phone:
734-936-0453
Email:
rashmim@med.umich.edu
Investigator:
Last name:
Rashmi Chugh, MD
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Van Tine, MD
Phone:
314-362-7997
Email:
bvantine@wustl.edu
Investigator:
Last name:
Brian Van Tine, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Viswatej Avutu, MD
Phone:
646-888-6860
Email:
avutuv@mskcc.org
Investigator:
Last name:
Viswatej Avutu, MD
Email:
Principal Investigator
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Juneko Grilley-Olson, MD
Phone:
919-668-6608
Email:
juneko.grilleyolson@duke.edu
Investigator:
Last name:
Juneko Grilley-Olson, MD
Email:
Principal Investigator
Facility:
Name:
Wake Forest Baptist (Atrium Health)
Address:
City:
Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Savage, MD
Phone:
336-716-5847
Email:
psavage@wakehealth.edu
Investigator:
Last name:
Paul Savage, MD
Email:
Principal Investigator
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ankit Mangla, MD
Phone:
216-844-5715
Email:
ankit.mangla@uhhospitals.org
Investigator:
Last name:
Ankit Mangla, MD
Email:
Principal Investigator
Facility:
Name:
Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Liebner, MD
Phone:
614-366-6087
Email:
David.Liebner@osumc.edu
Investigator:
Last name:
David Liebner, MD
Email:
Principal Investigator
Facility:
Name:
UPenn (Abramson Cancer Center, Pennsylvania Hospital)
Address:
City:
Philadelphia
Zip:
19106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Hartner, MD
Phone:
215-829-7089
Email:
Lee.Hartner@pennmedicine.upenn.edu
Investigator:
Last name:
Lee Hartner, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
John A Livingston, MD
Phone:
713-792-2848
Email:
jalivingston@mdanderson.org
Investigator:
Last name:
John A Livingston, MD
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin/ Froedtert Hospital
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
John Charlson, MD
Phone:
414-805-0818
Email:
jcharlso@mcw.edu
Investigator:
Last name:
John Charlson, MD
Email:
Principal Investigator
Facility:
Name:
UHN - Princess Margaret Cancer Center (Ontario)
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Albiruni Razak, MB BCh
Phone:
416-586-5371
Email:
albiruni.razak@uhn.ca
Investigator:
Last name:
Albiruni Razak, MB BCh
Email:
Principal Investigator
Facility:
Name:
McGill University Health Centre (Quebec)
Address:
City:
Montréal
Zip:
H4A 311
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Ramy Saleh, MD
Phone:
514-934-1934
Phone ext:
45367
Email:
ramy.saleh@mcgill.ca
Investigator:
Last name:
Ramy Saleh, MD
Email:
Principal Investigator
Facility:
Name:
Chang Gung Medical Foundation Kaohsiung
Address:
City:
Kaohsiung City
Zip:
83301
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Yu-Li Su, MD
Phone:
886 7 731 7123
Email:
yolisu@cgmh.org.tw
Investigator:
Last name:
Yu-Li Su, MD
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Wei-Wu (Tom) Chen, MD
Phone:
+886 2 2312 3456
Email:
tomwchen@ntuh.gov.tw
Investigator:
Last name:
Wei-Wu (Tom) Chen, MD
Email:
Principal Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Chueh-Chuan Yen
Phone:
+886 9 8176 4403
Email:
ccyen@vghtpe.gov.tw
Investigator:
Last name:
Chueh-Chuan Yen
Email:
Principal Investigator
Start date:
November 29, 2023
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Polaris Group
Agency class:
Industry
Source:
Polaris Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712694
