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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,467 Total Patients Enrolled
Oryzon Genomics S.A.Industry Sponsor
4 Previous Clinical Trials
254 Total Patients Enrolled
Namrata VijavergiaPrincipal InvestigatorFox Chase Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to iadademstat, paclitaxel, or their ingredients.I haven't had taxane-based treatments for my condition in the last 6 months, except as part of early cancer treatment.I can swallow pills and keep them down.I have not had surgery or significant injury within the last 4 weeks.I am a male willing to follow strict rules for preventing pregnancy during and 6 months after the study.I don't have another cancer that could affect this treatment's safety or results.I've had platinum-based chemo and up to 3 treatments for advanced cancer, but no taxane unless it was over 6 months ago.I am HIV-positive but in good health, or I have controlled Hepatitis B or C.I have never had severe drug-related brain side effects.I have lung disease and needed treatment for it in the last 3 months.I am not taking, nor expected to need, drugs that affect LSD1 within 3 weeks.I have not had radiotherapy in the last 2 weeks.I have undergone more than 3 different treatments.I have previously received anti-PD1 or anti-PD-L1 therapy.I have not been treated with platinum-based therapy.I am fully active or can carry out light work.I weigh at least 110 pounds.My cancer is advanced, cannot be surgically removed, and has specific aggressive features.I have at least one tumor that can be measured by standard criteria.I cannot or will not receive blood transfusions.I don't have stomach surgery or GI issues affecting drug absorption.I am older than 18 years.I am a woman who is either postmenopausal, surgically sterile, or willing to use contraception.I need assistance with my daily activities.I do not have any ongoing serious infections.My organ and bone marrow functions are normal.I have brain metastases that are not treated and may affect the trial treatment.My brain cancer has not worsened 4 weeks after treatment.I have a bleeding disorder or am on blood-thinning medication.I have had severe nerve damage from previous treatments that hasn't fully improved.I have not had significant bleeding or brain hemorrhage in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Iadademstat plus Paclitaxel
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still able to apply for this research trial?
"Evidenced by the information on clinicaltrials.gov, this trial is presently accepting applicants. This research was initially posted on December 21st 2022 and its details were most recently revised on January 5th 2023."
Answered by AI
How many participants are currently a part of this research program?
"Affirmative. According to the information on clinicaltrials.gov, this medical trial is presently accepting volunteers for participation. This project was originally uploaded on December 21st 2022 and has been amended as recently as January 5th 2023; furthermore, it requires 42 individuals from a single site."
Answered by AI
Are there health hazards associated with utilizing Iadademstat in conjunction with Paclitaxel?
"Our team at Power gave Iadademstat plus Paclitaxel a score of 2 on their safety assessment scale, as there is evidence to support its security but no data that proves it efficacy."
Answered by AI
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