Study on Iadademstat and Paclitaxel for Treating Relapsed or Hard-to-Treat Small Cell Lung Cancer and High-Grade Neuroendocrine Tumors
Sponsor: Fox Chase Cancer Center
ClinicalTrials ID:NCT05420636
This clinical trial is testing a combination of two drugs, iadademstat and paclitaxel, to see if they can help treat patients with small cell lung cancer (SCLC) or high-grade neuroendocrine tumors (NET) that have returned or are difficult to treat after initial therapies.
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Program Overview
The study aims to evaluate the effectiveness of combining iadademstat with paclitaxel in patients whose small cell lung cancer (SCLC) or high-grade neuroendocrine tumors (NET) have not responded to previous treatments. A total of 42 patients will participate, with 21 patients having SCLC and 21 having high-grade NET. The trial will include a safety phase with 12 patients to ensure the treatment is safe before proceeding with the full study.
Description
This clinical trial is designed for patients with small cell lung cancer (SCLC) or high-grade neuroendocrine tumors (NET) that have spread or cannot be removed by surgery. These patients must have already tried platinum-based chemotherapy but need further treatment. The study will test a combination of two drugs: iadademstat, taken orally, and paclitaxel, given through an IV. Iadademstat will be taken for five days in a row, followed by two days off, each week. Paclitaxel will be given once a week. The study will start with a safety phase involving 12 patients to ensure the treatment is safe. In total, 42 patients will be enrolled, with half having SCLC and the other half having high-grade NET. The goal is to see if this combination can help control the cancer and improve patient outcomes.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic or unresectable small cell lung cancer (SCLC) or high-grade neuroendocrine tumors (NET), including prostate or bladder cancer with these features.
- Previously treated with platinum-based chemotherapy (e.g., cisplatin, carboplatin).
- Have measurable disease that can be tracked using standard criteria.
- Be 18 years or older.
- Have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Weigh at least 50 kg (110 lbs).
- Have normal organ and bone marrow function, including specific blood cell counts and liver and kidney function.
- Be able to swallow oral medications.
- Have treated brain metastases that are stable for at least four weeks.
- Understand and agree to sign informed consent.
- HIV, Hepatitis B, and C patients can participate if their disease is controlled.
- Male participants must agree to use contraception and not donate sperm during and after the study.
- Female participants must be postmenopausal, surgically sterile, or agree to use contraception and not donate eggs during and after the study.
Exclusion Criteria
- Have received more than three lines of therapy.
- Have not received any platinum-based therapy.
- Have received previous taxane therapy, unless it was more than six months ago in a different treatment setting.
- Have a performance status of 2 or higher, indicating more severe physical limitations.
- Have another cancer that could interfere with the study.
- Have had recent radiotherapy, surgery, or investigational treatments.
- Have gastrointestinal issues that affect drug absorption.
- Are taking medications that interfere with the study drugs.
- Have a history of severe allergic reactions to the study drugs.
- Have untreated or symptomatic brain metastases.
- Have severe or uncontrolled medical conditions, including heart issues or infections.
- Are unable to receive blood products.
- Have a history of significant bleeding or current bleeding disorders.
- Are pregnant or breastfeeding.
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