Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06085729
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ADI-PEG 20 — DRUG
    Given by Injection
  • Cabazitaxel — DRUG
    Given by IV (vein)
  • Carboplatin — DRUG
    Given by IV (vein)

Study Details

To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.

Key Dates

Start date
Feb 29, 2024
Status verified
Jun 2026
Primary completion
Sep 2, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Monotherapy Maintenance
    Participants will be assigned to a study group and dose level of ADI-PEG20 based on when participant join this study. Up to 2 dose levels of ADI-PEG20 may be tested. Up to 15 participants will be enrolled per dose level.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Ana Aparicio, MD
[email protected]
713-563-6969
Ana Aparicio, MD (PRINCIPAL_INVESTIGATOR)

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By specialty
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By research site
MD Anderson Cancer Center· Houston, TX

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