Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC &

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

Patients with SCLC or extrapulmonary high grade neuroendocrine carcinomas with progression on or after platinum-based chemotherapy will be enrolled on this multi-center, single-arm phase II study. Patients must have histologically proven metastatic/unresectable SCLC or extrapulmonary G3 NEC (Ki-67 index > 20% with poorly differentiated histology), or metastatic/unresectable prostate or bladder cancer with high-grade neuroendocrine or small cell component. Patients must have received at least 1, but no more than 3 prior lines of therapy, which must include a platinum based agent. 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 and weekly paclitaxel at a dose of 80 mg/m2 IV). This fix dose of 150 microgram (liquid formulation) is in line with the 90 mg /m2/d BSA adjusted dose selected as RP2D in a 5d on, 2d off weekly schedule for iadademstat liquid formulation in combination with azacitidine per the ALICE AML Ph2 trial that showed to consistently achieve on average 90% target engagement. A safety lead-in phase with 12 patients will be conducted and these patients will be included in the final analysis. 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05420636
Study type	Interventional
Source	Fox Chase Cancer Center
Contact	Namrata Vijavergia
Phone	2152141676
Email	Namrata.Vijayvergia@fccc.edu
Status	Recruiting
Phase	Phase 2
Start date	December 21, 2022
Completion date	August 7, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms