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Histone Methyltransferase Inhibitor

Iadademstat + Paclitaxel for Lung Cancer

Phase 2

Recruiting

Led By Namrata Vijavergia

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is able to swallow oral medications and retain orally administered study treatment.

Patients who have received prior anti-PD1 or anti-PD-L1 therapy are eligible to enroll

Must not have

Patients with hypersensitivity to iadademstat, paclitaxel, or to any of its excipients.

Patients with prior history of NCI CTCAE Grade ≥ 3 drug-related central nervous system (CNS) toxicity.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trialwill test a new drug combo in patients with lung and other cancers. 42 people will take part, including those in the safety lead-in.

Who is the study for?

This trial is for adults over 18 with certain types of advanced cancers, including relapsed/refractory SCLC and high-grade extrapulmonary neuroendocrine carcinomas. Participants must have had platinum-based chemo but no taxane therapy unless it was over six months prior as neoadjuvant/adjuvant treatment. They should be able to swallow pills, not have severe infections or other health conditions that could interfere with the study, and agree to use effective contraception.

What is being tested?

The trial tests iadademstat combined with weekly paclitaxel in patients who've seen their cancer return or resist previous treatments. It's a phase II study involving two groups: one with small cell lung cancer (SCLC) and another with grade 3 neuroendocrine carcinomas (G3 NEC), each having 21 patients.

What are the potential side effects?

Potential side effects include reactions related to iadademstat or paclitaxel such as fatigue, nausea, hair loss from chemotherapy, low blood counts leading to increased infection risk or bleeding tendencies, nerve damage causing numbness or tingling in hands and feet, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills and keep them down.

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I have previously received anti-PD1 or anti-PD-L1 therapy.

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I am fully active or can carry out light work.

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I weigh at least 110 pounds.

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My cancer is advanced, cannot be surgically removed, and has specific aggressive features.

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I have at least one tumor that can be measured by standard criteria.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to iadademstat, paclitaxel, or their ingredients.

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I have never had severe drug-related brain side effects.

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I have undergone more than 3 different treatments.

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I have not been treated with platinum-based therapy.

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I cannot or will not receive blood transfusions.

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I need assistance with my daily activities.

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I do not have any ongoing serious infections.

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I have brain metastases that are not treated and may affect the trial treatment.

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I have a bleeding disorder or am on blood-thinning medication.

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I have had severe nerve damage from previous treatments that hasn't fully improved.

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I have not had significant bleeding or brain hemorrhage in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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 the Rate of grade III or higher toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Iadademstat plus PaclitaxelExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

0 / 18Eligibility criteria met