TerminatedPhase 2

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

Stopped: Closed to accrual due to low probability of successful outcomes

United States20 participantsStarted 2022-12-21

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients must have histologically or cytologically confirmed metastatic or unresectable, extrapulmonary G3 NEC (Ki-67 index \> 20% with poorly-differentiated histology), SCLC, or prostate or bladder cancer with high-grade neuroendocrine or small cell component
. Patients must have been previously treated with platinum-based chemotherapy regimens (cisplatin, carboplatin or oxaliplatin). Patients may have received up to 3 lines of treatment in the metastatic setting that might include immune checkpoint inhibitors, but no previous taxane based therapy. However, patients who have received neoadjuvant/adjuvant therapy with taxanes more than six months from enrollment are allowed to participate.
. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 11.0
. Patients who have received prior anti-PD1 or anti-PD-L1 therapy are eligible to enroll 5 Age \> 18 years. 6 ECOG performance status 0-1 7 Body weight \>/= 50 kg (110 lbs) 8 Patients must have normal organ and marrow function as defined below

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 2 years

Trial details

NCT IDNCT05420636

SponsorFox Chase Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-23

View on ClinicalTrials.gov More Small-cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients must have histologically or cytologically confirmed metastatic or unresectable, extrapulmonary G3 NEC (Ki-67 index \> 20% with poorly-differentiated histology), SCLC, or prostate or bladder cancer with high-grade neuroendocrine or small cell component
. Patients must have been previously treated with platinum-based chemotherapy regimens (cisplatin, carboplatin or oxaliplatin). Patients may have received up to 3 lines of treatment in the metastatic setting that might include immune checkpoint inhibitors, but no previous taxane based therapy. However, patients who have received neoadjuvant/adjuvant therapy with taxanes more than six months from enrollment are allowed to participate.
. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 11.0
. Patients who have received prior anti-PD1 or anti-PD-L1 therapy are eligible to enroll 5 Age \> 18 years. 6 ECOG performance status 0-1 7 Body weight \>/= 50 kg (110 lbs) 8 Patients must have normal organ and marrow function as defined below

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria