Testing a New Anti-Cancer Drug, M3814 (Peposertib), with Radiation Therapy for Locally Advanced Pancreatic Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04172532

Provider View

This clinical trial is exploring whether adding a new drug, M3814 (Peposertib), to the usual radiation therapy can safely and effectively treat pancreatic cancer that has spread to nearby tissues or lymph nodes.

Patient Parameters

Program Overview

This study is testing a new treatment approach for pancreatic cancer that has spread locally. It combines a new drug, M3814 (Peposertib), with a type of radiation therapy that delivers higher doses over a shorter time. The goal is to see if this combination is safe, tolerable, and more effective than radiation alone in stopping tumor growth.

Description

The study is divided into two phases. In Phase I, the focus is on determining the safety and best dose of M3814 when used with radiation therapy. In Phase II, researchers will compare how well patients do with the combination treatment versus radiation alone.

Primary Goals:

  • Assess the safety and tolerability of M3814 with radiation in patients with locally advanced pancreatic cancer.
  • Compare the time patients live without the cancer getting worse between those receiving the combination treatment and those receiving only radiation.

Secondary Goals:

  • Observe the anti-tumor effects of the treatment.
  • Study how the body processes M3814 during treatment.
  • Compare overall survival rates and tumor response rates between the two treatment groups.
  • Investigate genetic patterns in tumors that might predict response to the treatment.

Exploratory Goals:

  • Explore changes in genetic markers in the blood caused by the treatment.

Study Design:

  • Phase I involves gradually increasing doses of M3814 with radiation over two weeks.
  • Phase II involves randomly assigning patients to receive either the combination treatment or radiation with a placebo.

Participants will have blood samples and tissue biopsies taken, and undergo CT and MRI scans during the study. Follow-up visits will occur at 30, 60, and 90 days after treatment, and then every three months for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of pancreatic cancer.
  • Completed 4-6 months of initial chemotherapy with specific drugs.
  • Cancer must be locally advanced, as defined by specific medical guidelines.
  • At least 18 years old.
  • Good overall health with specific blood counts and organ function levels.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C patients must have controlled or cured infections.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Completed initial chemotherapy less than 2 weeks or more than 8 weeks before joining the study.
  • Not fully recovered from previous cancer treatment side effects.
  • Taking other experimental drugs.
  • Allergic to similar drugs as M3814.
  • Cancer has spread to distant parts of the body.
  • More than one line of chemotherapy for pancreatic cancer.
  • Previous abdominal radiation.
  • Active bowel or connective tissue diseases.
  • Unable to swallow pills or have digestive issues.
  • Severe allergic reaction to contrast used in imaging.
  • Taking certain medications that interact with the study drug.
  • Received a live vaccine within 30 days of starting the study.
  • Uncontrolled health issues or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • Other cancers that could interfere with the study.

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