Study on L-DOS47 and Doxorubicin for Advanced Pancreatic Cancer

Sponsor: Helix BioPharma Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04203641

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combining L-DOS47 with doxorubicin for patients with advanced pancreatic cancer who have already received other treatments.

Patient Parameters

Program Overview

The study aims to find out if combining L-DOS47 with doxorubicin is safe and can help shrink tumors in patients with advanced pancreatic cancer. It will start by testing different doses of L-DOS47 to find the best amount to use with doxorubicin. Once the best dose is found, the study will continue to see how well this combination works in reducing tumors and ensuring patient safety.

Description

The study is divided into two parts. In the first part, researchers will test different doses of L-DOS47 combined with a fixed dose of doxorubicin to find the safest and most effective dose. Patients will be divided into groups, with each group receiving a higher dose of L-DOS47. If any serious side effects occur, more patients will be added to that group to ensure safety. Up to 18 patients may participate in this part.

In the second part, the study will focus on how well the treatment works in shrinking tumors and continue to monitor safety. An additional 11 patients will be included to see if the treatment shows enough promise to be tested in a larger trial. Patients will receive the dose of L-DOS47 determined in the first part, along with doxorubicin. Tumor markers and scans will be used to track the cancer's response to the treatment.

Safety will be monitored through reports of any side effects, physical exams, heart tests, and various lab tests to check blood and organ function.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have one or more tumors that can be measured by scans, consistent with pancreatic cancer.
  • Be in good general health with a performance status of 70% or higher.
  • Have a life expectancy of at least 3 months.
  • Be able to understand the study and provide written consent.
  • Women of childbearing potential must have a negative pregnancy test.
  • Have acceptable liver and kidney function based on specific blood tests.
  • Have adequate blood cell counts and normal blood clotting times.
  • Agree to use effective contraception during the study if of childbearing potential.
  • Have normal heart function as shown by specific heart tests.

Exclusion Criteria

  • Have severe heart disease or recent heart attack.
  • Have abnormal heart function on specific tests.
  • Have active, uncontrolled infections.
  • Be pregnant or breastfeeding.
  • Have received certain treatments like radiation, surgery, or chemotherapy recently.
  • Have had major surgery within the last 4 weeks.
  • Be unable or unwilling to follow study procedures.
  • Have known infections like HIV or hepatitis.
  • Have serious non-cancerous diseases that could affect the study.
  • Be taking other experimental treatments.
  • Have uncontrolled brain cancer or cancer in the brain's lining.
  • Have a prolonged QT interval on heart tests.

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