Study of PM14 and Irinotecan for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment combination for patients with certain types of advanced cancers, known as solid tumors. The study involves two medications: PM14, which is a new drug being tested, and irinotecan, a medication already used in cancer treatment. The purpose of the study is to find the best dose of PM14 when used with irinotecan and to see how well this combination works against these cancers.

The study is divided into two main parts. In the first part, different doses of PM14 will be tested to find the highest dose that patients can tolerate without severe side effects. This is known as the dose escalation stage. In the second part, called the expansion stage, the dose found in the first part will be used to treat more patients to see how effective the combination is in shrinking tumors. Patients will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein.

The study will include patients who have already tried other treatments for their cancer but did not have success. The types of cancers being studied include various advanced solid tumors such as certain lung, gastrointestinal, and gynecological cancers, among others. The study aims to understand how well the combination of PM14 and irinotecan works in treating these cancers and to gather information on any side effects experienced by the patients.

1 joining the study

Upon joining the study, the patient must provide a signed and dated written informed consent. This is a formal agreement to participate in the trial after understanding its details.

The patient must be at least 18 years old and have a performance status that allows them to carry out daily activities with minimal assistance.

2 initial assessment

The patient will undergo an initial assessment to confirm the presence of selected advanced solid tumors. This includes various types of cancers such as gastrointestinal, lung, sarcoma, gynecological, breast, genitourinary, and others.

The patient must have adequate bone marrow, renal, hepatic, and metabolic function, which will be assessed through blood tests.

3 phase I: dose escalation

In this phase, the patient will receive increasing doses of PM14 in combination with irinotecan to determine the maximum tolerated dose (MTD) and the recommended dose (RD).

The medications are administered through intravenous infusion. The dose escalation may involve the use of a granulocyte colony-stimulating factor to manage potential side effects related to low white blood cell counts.

4 phase II: expansion

Once the recommended dose is established, the patient will continue to receive PM14 and irinotecan at this dose to evaluate the treatment’s effectiveness.

The patient’s response to the treatment will be monitored using criteria that assess changes in tumor size and progression.

5 treatment administration

The patient will receive PM14 and irinotecan as a powder for concentrate, which is then prepared for infusion. The frequency and duration of administration will be determined by the study protocol and the patient’s response to treatment.

6 safety and efficacy evaluation

Throughout the trial, the patient will be monitored for any adverse effects. These will be graded according to established criteria to ensure safety.

The effectiveness of the treatment will be evaluated based on the patient’s clinical or radiological tumor assessments.

7 pharmacokinetic and pharmacogenetic analysis

Blood samples will be collected to analyze how the body processes the medications. This includes studying the distribution, metabolism, and excretion of PM14.

Genetic analysis may be performed to understand individual differences in response to the treatment.

Who Can Join the Study?

You must sign a written consent form before any study procedures begin.
You need to be at least 18 years old.
Your overall health should be good enough to perform daily activities, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1. This means you are fully active or have some symptoms but can still do light work.
You must have a confirmed diagnosis of certain advanced solid tumors, which means the cancer has spread and is not responding to standard treatments. These tumors include:
- Gastrointestinal cancers like esophageal, stomach, pancreatic, liver, and certain neuroendocrine tumors.
- Lung cancers, both non-small cell and small cell types.
- Types of sarcoma, such as liposarcoma and Ewing’s sarcoma.
- Gynecological cancers, including ovarian, endometrial, and cervical cancers.
- Breast cancers, both ductal and lobular types.
- Genitourinary cancers, like bladder, kidney, and prostate cancers.
- Other cancers like malignant pleural mesothelioma and adrenocortical carcinoma.
For the expansion stage of the study, your disease must be measurable and have shown progression during or right after your last treatment.
You need to have a break from previous treatments:
- At least three weeks since your last chemotherapy, high-dose radiation, or certain antibody treatments.
- At least two weeks since your last biological or experimental treatment, or low-dose radiation.
- If you have hormone-sensitive breast cancer, you must stop all hormone therapies at least one week before starting the study treatment, except for certain medications in pre-menopausal women.
- If you have prostate cancer that no longer responds to hormone therapy, you can continue hormone therapy during the study.
Your body must be functioning well enough, which includes:
- Having enough blood cells, with a platelet count of at least 100, hemoglobin of at least 9.0, and a certain type of white blood cell count of at least 2.0.
- Liver enzymes (AST and ALT) should be no more than three times the normal limit, even if you have liver metastases.
- Alkaline phosphatase should be no more than 2.5 times the normal limit, or 5 times if related to liver disease.
- Total bilirubin should be no more than 1.5 times the normal limit, or direct bilirubin should be normal.
- Your kidneys should be able to clear creatinine at a rate of at least 30 mL per minute.
- Creatine phosphokinase should be no more than 2.5 times the normal limit.
- Serum albumin should be at least 3.0.
You should have recovered from any side effects of previous treatments to a mild level or back to your normal state, except for hair loss, skin issues, nerve damage, or mild fatigue.

Who Cannot Join the Study?

Patients who have not been diagnosed with advanced solid tumors. These are types of cancer that form in solid organs or tissues, like the lungs or liver, and have progressed to a more severe stage.
Patients who are not within the specified age range for the study. The study may have specific age requirements that participants must meet.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care, such as children or those with certain disabilities.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients who are pregnant or breastfeeding, as the study may involve medications that could affect the baby.
Patients who have allergies or reactions to the study medications or similar drugs.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Fqalfsoyt Pmva Lp Itbhgoriqnstc Briesehhx Dvs Hcavwpan Uzjmdystsslpa Ln Pmt	Madrid	Spain
Hxyywrjp Vbgw ddzsupgq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	25.01.2021

Trial locations

Investigated drugs:

Irinotecan

PM14 is an investigational medication being studied for its potential to treat advanced solid tumors. In this clinical trial, PM14 is being tested to find the best dose that patients can tolerate when used in combination with another cancer treatment. Researchers are also looking at how well PM14 works in shrinking tumors or stopping them from growing.

Irinotecan is a chemotherapy drug that is already used to treat certain types of cancer. In this trial, it is combined with PM14 to see if the two medications together can be more effective in treating advanced solid tumors. Irinotecan works by interfering with the DNA of cancer cells, which can stop them from growing and dividing.

Investigated diseases:

Neoplasm malignant

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body through the bloodstream or lymphatic system. The progression of these tumors often leads to symptoms related to the affected organ, such as pain, swelling, or dysfunction. The complexity of these tumors can vary, and they may exhibit different growth rates and patterns. Understanding the specific characteristics of each tumor type is crucial for determining appropriate management strategies.

Trial ID:

2024-514890-24-00

Protocol code:

PM14-A-002-20

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of PM14 and Irinotecan for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?