Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC and Extrapulmonary High Grade NET
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05420636|
Recruitment Status : Recruiting
First Posted : June 15, 2022
Last Update Posted : January 9, 2023
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer Neuroendocrine Carcinoma||Drug: Iadademstat Drug: Paclitaxel||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Iadademstat in Combination With Paclitaxel in Relapsed or Refractory Small Cell Lung Cancer and Extrapulmonary High Grade Neuroendocrine Carcinomas|
|Actual Study Start Date :||December 21, 2022|
|Estimated Primary Completion Date :||August 5, 2024|
|Estimated Study Completion Date :||August 7, 2026|
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.
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)
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).
- 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 ]To determine Overall response rate (ORR) per RECIST1.1 ORR is defined as patients who meet criteria for Complete Response (CR) or Partial response (PR).
- To determine the Rate of grade III or higher toxicities [ Time Frame: 2 years ]To evaluate the safety of iadademstat in combination with paclitaxel in relapsed/refractory SCLC and extrapulmonary high grade neuroendocrine cancers using CTCAE version 5.0
- Progression free survival (PFS), defined as the time from initiation of study drug until documented radiographic progression, clinical progression, death, or the end of follow-up, whichever occurs first. [ Time Frame: 2 years ]To determine Progression Free Survival as per RECIST 1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05420636
|Contact: Namrata Vijavergia||2152141676||Namrata.Vijayvergia@fccc.edu|
|Contact: Tanu firstname.lastname@example.org|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Namrata Vijayvergia, MD 215-214-1515 Namrata.Vijayvergia@fccc.edu|
|Principal Investigator:||Namrata Vijavergia||Fox Chase Cancer Center|