Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Polaris Group
Study ID
NCT05712694
Phase
PHASE3
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ADI PEG20 — DRUG
    Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)
  • Placebo — OTHER
    Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)

Study Details

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Key Dates

Start date
Nov 29, 2023
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADIGemDoc
    ADI-PEG 20: 36 mg/m2 on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 600 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 60 mg/m2 on day 8 of each 21-day cycle
  • Placebo Comparator: PBOGemDoc
    Placebo: matched PBO on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 900 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 75 mg/m2 on day 8 of each 21-day cycle

Primary Outcome Measure

Primary End Point of PFS [ Time Frame: Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years). ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Mahesh Seetharam, MD
[email protected]
Mahesh Seetharam, MD (PRINCIPAL_INVESTIGATOR)
USC Norris comprehensive cancer centerLos AngelesCalifornia90033
Mark Agulnik, M.D
[email protected]
323-865-3935
Mark Agulnik, M.D (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CentrePalo AltoCalifornia94304
Nam Bui, MD
[email protected]
650-725-6413
Kristen Ganjoo, MD
[email protected]
650-725-6413
Nam Bui, MD (PRINCIPAL_INVESTIGATOR)
UCSFSan FranciscoCalifornia94158
Varun Monga, M.D
[email protected]
415-514-7279
Varun Monga, M.D (PRINCIPAL_INVESTIGATOR)
UCLASanta MonicaCalifornia90404
Arun Singh, M.D
[email protected]
310-829-5471
Arun Singh, M.D (PRINCIPAL_INVESTIGATOR)
University of Colorado Cancer Center/ CU Anschutz Medical CampusAuroraColorado80045
Breelyn Wilky, MD
[email protected]
720-848-0300
Breelyn Wilky, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Steven Attia, DO
[email protected]
Steven Attia, DO (PRINCIPAL_INVESTIGATOR)
University of Miami/ Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Emily Jonczak, MD
[email protected]
305-243-2581
Emily Jonczak, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Mihaela Druta, MD
[email protected]
813-745-3242
Mihaela Druta, MD (PRINCIPAL_INVESTIGATOR)
NorthwesternChicagoIllinois60611
Seth Pollack, MD
[email protected]
312-695-1300
Seth Pollack, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Samantha Armstrong, MD
[email protected]
317-278-2686
Samantha Armstrong, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242-
Mass General Brigham Cancer CenterBostonMassachusetts02114
Edwin Choy, M.D
[email protected]
617-724-4000
Edwin Choy, M.D (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Rashmi Chugh, MD
[email protected]
734-936-0453
Rashmi Chugh, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Brittany Siontis, M.D
[email protected]
507-284-2511
Brittany Siontis, M.D (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110
Brian Van Tine, MD
[email protected]
3143627997
Brian Van Tine, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Igor Matushansky, M.D.Ph.D
[email protected]
917-757-8392
Igor Matushansky, M.D.Ph.D (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Viswatej Avutu, MD
[email protected]
646-888-6860
Viswatej Avutu, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Matthew Ingham, MD
[email protected]
212-731-5324
Matthew Ingham, MD (PRINCIPAL_INVESTIGATOR)
Duke Cancer InstituteDurhamNorth Carolina27710
Juneko Grilley-Olson, MD
[email protected]
919-668-6608
Juneko Grilley-Olson, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Ankit Mangla, MD
[email protected]
216-844-5715
Ankit Mangla, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research InstituteColumbusOhio43210
David Liebner, MD
[email protected]
614-366-6087
David Liebner, MD (PRINCIPAL_INVESTIGATOR)
UPenn (Abramson Cancer Center, Pennsylvania Hospital)PhiladelphiaPennsylvania19106
Lee Hartner, MD
[email protected]
215-829-7089
Lee Hartner, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Melissa Burgess, M.D
[email protected]
412-692-4724
Melissa Burgess, M.D (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
John A Livingston, MD
[email protected]
713-792-2848
John A Livingston, MD (PRINCIPAL_INVESTIGATOR)
Medical College of Wisconsin/ Froedtert HospitalMilwaukeeWisconsin53226
John Charlson, MD
[email protected]
414-805-0818
John Charlson, MD (PRINCIPAL_INVESTIGATOR)

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