PEN-866 in Patients With Advanced Solid Malignancies

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Tarveda Therapeutics
Study ID
NCT03221400
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PEN-866 Sodium — DRUG
    PEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion.
  • fluorouracil — DRUG
    Fluorouracil 2400 mg/m2 IV
  • Folinic acid — DRUG
    Folinic acid 400 mg/m2 IV
  • Niraparib — DRUG
    Niraparib

Study Details

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

Key Dates

Start date
Aug 29, 2017
Status verified
Feb 2022
Primary completion
Jan 31, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
340 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a PEN-866 Sodium (Single Agent)
    Dose escalation of PEN-866 Sodium administered intravenously
  • Experimental: Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid
    Dose escalation of intravenous administration of PEN-866 Sodium in combination with fluorouracil and folinic acid
  • Experimental: Phase 2a PEN-866 Sodium (Single Agent)
    Intravenously administered PEN-866 Sodium at the Recommended Phase 2 Dose
  • Experimental: Phase 1b PEN-866 Sodium + Niraparib
    Dose escalation of intravenous administration of PEN-866 Sodium in combination with niraparib

Primary Outcome Measure

Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Patients will be followed for 28 days to determine the incidence of DLTs. ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupSpringdaleArkansas72762-
Sarah Cannon Reasearch Institute at HealthONEDenverColorado80218-
Florida Cancer Specialists - SouthFort MyersFlorida33901-
Florida Cancer Specialists - NorthSt. PetersburgFlorida33705-
Florida Cancer Specialists - EastWest Palm BeachFlorida33401-
National Institutes of Health / National Cancer InstituteBethesdaMaryland20892-
Henry FordDetroitMichigan48202-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Stephenson Cancer Center, University of OklahomaOklahoma CityOklahoma73104-
Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Prisma Health - UpstateGreenvilleSouth Carolina29605-
The West ClinicGermantownTennessee38138-
Tennessee OncologyNashvilleTennessee37203-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Highlands Oncology Group· Springdale, ARSarah Cannon Reasearch Institute at HealthONE· Denver, COFlorida Cancer Specialists - South· Fort Myers, FLFlorida Cancer Specialists - North· St. Petersburg, FLFlorida Cancer Specialists - East· West Palm Beach, FLNational Institutes of Health / National Cancer Institute· Bethesda, MD

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