Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC and Extrapulmonary High Grade NET

Part of paid clinical trials in Buffalo, New York.

Sponsor
Fox Chase Cancer Center
Study ID
NCT05420636
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Iadademstat — DRUG
    Patients will be treated with iadademstat given at a dose of 150 microgram PO administered on a 5 day on-2 day off schedule every week (days 1 through 21)
  • Paclitaxel — DRUG
    Patients will be treated with Paclitaxel given at a dose of 80 mg/m2 intravenous administration weekly day 1, 8 and 15 (days 1 through 21).

Study Details

This is a non-randomized single-arm, two cohorts, phase II study of iadademstat in combination with weekly paclitaxel in patients with relapse/refractory SCLC or extrapulmonary G3 Neuroendocrine Carcinomas. A total of 42 patients with SCLC (21 patients) and G3 NEC (21 patients) will be enrolled (including those enrolled in the safety lead-in portion).

Key Dates

Start date
Dec 21, 2022
Status verified
Jul 2025
Primary completion
Jul 23, 2025
Completion
Jul 23, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iadademstat plus Paclitaxel
    Iadademstat oralon a 5 day ON and 2-day OFF schedule every week plus Paclitaxel administered intravenously weekly on day 1, 8 and 15 on day 1 of a 21 day treatment cycle.

Primary Outcome Measure

To evaluate the efficacy in terms of response rate of iadademstat combination with paclitaxel in relapsed/refractory SCLC and extrapulmonary high grade neuroendocrine cancers. Assessments will be performed after every 2 cycles of treatments. [ Time Frame: 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Buffalo, NY

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Roswell Park Cancer Institute· Buffalo, NYFox Chase Cancer Center· Philadelphia, PAHuntsman Cancer Institute· Salt Lake City, UT

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