Small-cell Lung CancerPhase 2NCT05420636
Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC and Extrapulmonary High Grade NET
A Phase 2 study testing Iadademstat and Paclitaxel in people with Small-cell Lung Cancer and Neuroendocrine Carcinoma, run by Fox Chase Cancer Center at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-cell Lung Cancer, Neuroendocrine Carcinoma
- What is being tested?
- Iadademstat and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Dec 2022to 23 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Absolute neutrophil count > 1,500/mcL
- Hemoglobin > 9 mg/dl
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- Platelets > 100,000/mcL (patients cannot receive platelet transfusions to meet eligibility criteria)
- Total bilirubin < 1.5 X ULN (Pts with Gilbert's can enroll if conjugated bilirubin is within normal limits)
- AST/ALT (SGOT/SGPT) < 3 x ULN if not disease related. If liver metastasis, AST/ALT up to 5 x ULN allowed.
- Creatinine <1.5 X ULN OR
- Creatinine clearance > 60 ml/min/1.73 m2 for patients
- 9 Patient is able to swallow oral medications and retain orally administered study treatment.
- 10 Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- 11 Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
- 12 HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. Similarly, Hepatitis B and C infected patients are allowed if disease is controlled (testing not required for eligibility assessment) 13 Male patients even if surgically sterilized (i.e., status post-vasectomy) who agree to:
- Practice true abstinence or highly effective barrier contraception during the entire study treatment period and through 180 days after the last dose of study drug.
- Not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug.
- 14 Female patients who:
- Are postmenopausal for at least 1 year before the initial consent is signed, OR b. Are documented as surgically sterile (at least 1 month prior to consenting), OR c. If they are of childbearing potential, agree to: i. use of two methods of contraception (e.g., one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g., combined oral contraceptives, patch, vaginal ring, injectable and implants]) during the trial and 180 days after the end of treatment.
- practice true abstinence during the trial and 180 days after the end of treatment.
- have a negative urine pregnancy test at screening iv. not to donate or freeze egg(s) during the course of this study or within 180 days after receiving their last dose of study drug.
Who cannot join
- Patients who have received more than 3 lines of therapy
- Patients who have not received any platinum-based therapy
- Patients who have received previous therapy with taxanes, unless received in the neoadjuvant/adjuvant setting and longer than six months from last taxane treatment.
- ECOG performance status >/=2
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen as per treating MD
- Patients who have received radiotherapy less than 2 weeks prior to first dose of study medication.
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- Surgical procedure or clinically significant trauma within 4 weeks of first dose of study treatment.
- Treatment with any investigational agent ≤ 3 weeks prior to first dose of study treatment.
- Patients with gastrectomy or pre-existing gastrointestinal (GI) disorders that may interfere with the proper absorption of the drug(s), as per conclusion of the clinical Investigator.
- Patients medicated with, or the expected need for treatment with agents reported to have LSD1 inhibitory activity (such as tranylcypromine or phenelzine) within 3 weeks of treatment start also refer to section 5.2 for the list of concomitant medications.
- History of allergic reactions attributed to components of the formulated product(s). (see appendix)
- Patients with prior history of NCI CTCAE Grade ≥ 3 drug-related central nervous system (CNS) toxicity.
- Patients with untreated, symptomatic CNS metastases likely to interfere with the experimental therapy as per the investigator-sponsor
- Patients with prior history of grade ≥2 neurotoxicity that was not resolved to grade ≤1 (prior therapy toxicity)
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or pose a higher risk of toxicities as per discretion of the treating physician in agreement with the investigator-sponsor (including but not limited to:)
- Unstable angina, symptomatic or otherwise uncontrolled arrhythmia (does not include stable, lone atrial fibrillation), QTcF > 480 ms based on the average of 3 screening electrocardiograms (ECGs), symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study treatment, cerebrovascular accidents ≤ 6 months before study treatment start.
- Patient has evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Any other serious and uncontrolled medical illnesses, uncontrolled seizures that may affect study participation or patient safety, as assessed by investigator.
- Patients who refuse or are unable to potentially receive blood products
- Any medical condition which, in the opinion of the Investigator, places the patient at an unacceptable risk for toxicities if entered into the clinical study.
- Patients with history of clinically significant bleeding, specifically any history of intracranial hemorrhage / hemorrhagic cardiovascular accident (CVA), or patients with gastrointestinal bleeding within the 3 months prior to study entry.
- Patients with current interstitial lung disease, requiring systemic therapy within the last 3 months.
- Patients with hypersensitivity to iadademstat, paclitaxel, or to any of its excipients.
- Patients with known irreversible bleeding disorders or receiving antiplatelet therapy for other indications. Use of low dose aspirin (<100 mg) is allowed.
- Patients pregnant or breast feeding. Refer to section 4.4 for further detail. Female patient must agree not to breastfeed at screening and throughout the study period and for 60 days after the final study drug administration.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
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
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).
Read the detailed 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).
- Conditions
- Small-cell Lung Cancer, Neuroendocrine Carcinoma
- Being tested
- Iadademstat, Paclitaxel
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IadademstatDrug
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)
PaclitaxelDrug
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 group | Role | What they receive |
|---|---|---|
| Iadademstat plus Paclitaxel | Experimental | 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. Receives: Drug: Iadademstat; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: 2 years
Secondary outcomes (2)
To determine the Rate of grade III or higher toxicities
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
Measured: 2 years
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.
To determine Progression Free Survival as per RECIST 1.1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start21 Dec 2022
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Why it stopped: Closed to accrual due to low probability of successful outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oryzon Genomics S.A.
- Responsible party
- Sponsor
- Investigators
- Namrata Vijavergia, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420636
- Sponsor's protocol ID
- GI-203
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05420636
- Acronym / sponsor ID
- GI-203
- Conditions
- Small-cell Lung Cancer, Neuroendocrine Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed to accrual due to low probability of successful outcomes
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Oryzon Genomics S.A.
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iadademstat plus Paclitaxel | Experimental | Drug: Iadademstat, Drug: PaclitaxelIadademstat 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- 9 Patient is able to swallow oral medications and retain orally administered study treatment.
Key exclusion criteria (25 listed)
- Patients who have received more than 3 lines of therapy
- Patients who have not received any platinum-based therapy
- Patients who have received previous therapy with taxanes, unless received in the neoadjuvant/adjuvant setting and longer than six months from last taxane treatment.
- ECOG performance status >/=2
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen as per treating MD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IadademstatPatients 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) | Drug | Iadademstat plus Paclitaxel |
| PaclitaxelPatients 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). | Drug | Iadademstat plus Paclitaxel |
Primary outcome
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).
2 secondary outcomes
To determine the Rate of grade III or higher toxicities
Time frame: 2 years
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
Results and safety
The study was stopped early (reason given: Closed to accrual due to low probability of successful outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namrata Vijavergia principal investigator
Fox Chase Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iadademstat and Paclitaxel in people with Small-cell Lung Cancer and Neuroendocrine Carcinoma, run by Fox Chase Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closed to accrual due to low probability of successful outcomes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.