Study on Lurbinectedin and Irinotecan for Patients with Certain Advanced Cancers

Sponsor: PharmaMar

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02611024

Provider View

This clinical trial is testing a combination of two drugs, Lurbinectedin and Irinotecan, to find the best dose and see how well they work together in treating certain advanced cancers. The study is divided into two parts: finding the right dose and then expanding to more patients if the treatment shows promise.

Patient Parameters

Program Overview

The study aims to determine the best dose and effectiveness of combining Lurbinectedin and Irinotecan for treating advanced solid tumors. It consists of two stages: Phase I, where different doses are tested to find the safest and most effective one, and Phase II, where the treatment is given to more patients to see how well it works.

Description

In the first part of the study (Phase I), patients with advanced solid tumors will be divided into groups to test different doses of Lurbinectedin and Irinotecan. The goal is to find the highest dose that patients can tolerate without severe side effects. Patients will receive treatment every three weeks, and the dose will be increased gradually until the best dose is found.

Once the best dose is determined, the study will move to Phase II, where more patients will receive the treatment to see if it helps shrink tumors. If the treatment shows promise in certain types of cancer, more patients with those cancers will be included.

The study will also include a special group of patients with neuroendocrine tumors, who will receive the treatment at the determined best dose. This group will be divided into two: one with poorly differentiated neuroendocrine cancer and another with well-differentiated neuroendocrine tumors.

Additionally, the study will expand to include more patients with small cell lung cancer and soft tissue sarcoma if the treatment shows effectiveness. An independent committee will review the results to ensure accurate assessment of the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced cancer from a specific list of types, such as glioblastoma, soft tissue sarcoma, or small cell lung cancer.
  • Have a good overall health status, with a performance score of 0 or 1.
  • Have a life expectancy of at least 3 months.
  • Have received no more than two prior chemotherapy treatments for advanced cancer.
  • For Phase II, must have measurable disease and documented progression after the last therapy.
  • Must have adequate blood counts and organ function.
  • Must have recovered from any side effects of previous treatments.
  • Women of childbearing potential must agree to use effective contraception during and after the study.

Exclusion Criteria

  • Have certain heart conditions or uncontrolled arrhythmias.
  • Have muscle disorders causing high levels of CPK.
  • Have ongoing alcohol abuse or severe liver disease.
  • Have active infections like HIV or hepatitis.
  • Have chronic inflammatory bowel or liver disease.
  • Have severe lung conditions or rapidly increasing fluid around the lungs or heart.
  • Have any major illness that increases risk.
  • Have active COVID-19.
  • Have allergies to study drugs.
  • Have had prior treatment with Lurbinectedin or similar drugs.
  • Have had bone marrow or stem cell transplants.
  • Have untreated brain metastases, unless stable and not requiring steroids.
  • Are pregnant or breastfeeding, or not using effective contraception if fertile.

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