42 Participants Needed

Iadademstat + Paclitaxel for Lung Cancer

Recruiting at 2 trial locations
NV
Ts
Overseen ByTanu singh
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Fox Chase Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications with LSD1 inhibitory activity (like tranylcypromine or phenelzine) within 3 weeks of starting the trial. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination Iadademstat and Paclitaxel for lung cancer?

Paclitaxel has shown effectiveness in treating lung cancer, with studies reporting response rates of up to 41% in non-small cell lung cancer. It is often used in combination with other drugs, like platinum compounds, to enhance its effectiveness.12345

Is the combination of Iadademstat and Paclitaxel safe for humans?

Paclitaxel, also known as Taxol, has been used in various cancer treatments and is generally considered safe with manageable side effects like neutropenia (low white blood cell count) and neuropathy (nerve damage). Abraxane, a form of Paclitaxel, has been shown to be safe in treating lung cancer, with side effects reduced by premedication.12567

How is the drug combination of Iadademstat and Paclitaxel unique for treating lung cancer?

The combination of Iadademstat and Paclitaxel for lung cancer is unique because it involves Iadademstat, a novel drug that may work differently from traditional chemotherapy agents, potentially offering a new mechanism of action. Paclitaxel is already known for its effectiveness in lung cancer, and combining it with Iadademstat could enhance its effects or provide benefits not seen with existing treatments.12589

Research Team

NV

Namrata Vijavergia

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I can swallow pills and keep them down.
I am a male willing to follow strict rules for preventing pregnancy during and 6 months after the study.
I've had platinum-based chemo and up to 3 treatments for advanced cancer, but no taxane unless it was over 6 months ago.
See 11 more

Exclusion 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 have not had surgery or significant injury within the last 4 weeks.
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

A safety lead-in phase with 12 patients to assess initial safety and tolerability

6 weeks
Weekly visits for treatment and monitoring

Treatment

Participants receive iadademstat and paclitaxel in a 21-day cycle with weekly administration

2 years
Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • Iadademstat
  • Paclitaxel
Trial OverviewThe 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.
Participant Groups
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.

Iadademstat is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Iadademstat for:
  • Orphan drug designation for Acute Myeloid Leukemia (AML)
🇪🇺
Approved in European Union as Iadademstat for:
  • Orphan drug designation for Acute Myeloid Leukemia (AML)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Oryzon Genomics S.A.

Industry Sponsor

Trials
5
Recruited
350+

Findings from Research

Paclitaxel has demonstrated strong antitumor activity in various cancers, including ovarian, breast, and lung carcinoma, especially when combined with platinum compounds like cisplatin and carboplatin.
Recent large randomized trials in Europe have explored the effectiveness of paclitaxel in combination with platinum for treating non-small cell lung cancer, showing promising results and leading to ongoing studies on its use in preoperative settings and with radiotherapy.
European perspectives on paclitaxel/platinum-based therapy for advanced non-small cell lung cancer.Novello, S., Le Chevalier, T.[2019]
Paclitaxel (TAXOL) has shown promising efficacy in treating lung cancer, with objective response rates of 21% and 24% in patients with non-small cell lung cancer, and a higher response rate of 34% in patients with extensive-stage small cell lung cancer.
Further research is necessary to explore the effectiveness of paclitaxel as a standalone treatment for small cell lung cancer and its potential as a radiosensitizer or in combination with other therapies.
Overview of paclitaxel (Taxol) in advanced lung cancer.Ettinger, DS.[2015]
The combination of paclitaxel and vinorelbine was effective as a first-line treatment for untreated patients with metastatic lung adenocarcinoma, with a response rate of 50% and a median survival of 10 months based on a study of 54 patients.
While myelotoxicity was a common side effect affecting 87% of patients, severe neutropenia (grade 4) occurred in only 14.8%, indicating that the treatment regimen was manageable and did not require dose reductions for most patients.
Paclitaxel and vinorelbine combination in advanced inoperable adenocarcinoma of the lung: a phase II study.Stathopoulos, GP., Veslemes, M., Georgatou, N., et al.[2018]

References

European perspectives on paclitaxel/platinum-based therapy for advanced non-small cell lung cancer. [2019]
Overview of paclitaxel (Taxol) in advanced lung cancer. [2015]
Paclitaxel and vinorelbine combination in advanced inoperable adenocarcinoma of the lung: a phase II study. [2018]
Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial. [2022]
Single-agent paclitaxel and paclitaxel/non-platinum combination therapy in advanced non-small cell lung cancer. [2022]
Efficacy and safety of Abraxane in treatment of progressive and recurrent non-small cell lung cancer patients: A retrospective clinical study. [2019]
Paclitaxel (Taxol): a review of its antitumor activity in clinical studies Minireview. [2015]
Combination paclitaxel and platinum in the treatment of lung cancer: US experience. [2015]
Defining the role of paclitaxel in lung cancer: summary of recent studies and implications for future directions. [2015]