PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05465941
Phase
PHASE2
Status
Recruiting
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Conditions

  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Pegylated SN-38 Conjugate PLX038 — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Biospecimen Collection — PROCEDURE
    Undergo blood and stool sample collection

Study Details

This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Sep 14, 2022
Status verified
Feb 2026
Primary completion
Feb 15, 2027
Completion
Dec 31, 2031

Study Design

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

Arms

  • Experimental: Treatment (pegylated SN-38 conjugate PLX038)
    Patients receive PLX038 IV over 1 hour on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, biopsy, as well as blood and stool sample collection during screening and on the trial.

Primary Outcome Measure

Proportion of confirmed tumor responses [ Time Frame: Up to first 6 cycles of treatment (1 cycle = 21 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Clinical Trial Referral Office
[email protected]
855-776-0015
Andrea E. Wahner Hendrickson, M.D. (PRINCIPAL_INVESTIGATOR)
Scott H. Kaufmann, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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