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Imifoplatin

Imifoplatin, also known as PT-112, is an innovative drug currently being studied in clinical trials for the treatment of advanced solid tumors, particularly metastatic castration-resistant prostate cancer (mCRPC). This article explores the ongoing research into Imifoplatin’s safety, effectiveness, and potential benefits for patients with advanced prostate cancer who have undergone multiple prior treatments.

Table of Contents

What is IMIFOPLATIN?

IMIFOPLATIN, also known as PT-112, is a new drug being studied for the treatment of advanced prostate cancer[1]. It belongs to a class of drugs called platinum-containing therapies, which are known for their potential in fighting cancer. IMIFOPLATIN is currently undergoing clinical trials to evaluate its safety and effectiveness in patients with advanced solid tumors, particularly those with metastatic castration-resistant prostate cancer (mCRPC)[1].

Other names for IMIFOPLATIN include[1]:

  • (R,R)-1,2-CYCLOHEXANEDIAMINE PYROPHOSPHATOPLATINUM(II)
  • PT-112
  • CYCLOHEXANE-(1R,2R)-DIAMINEPLATINUM(II) DIPHOSPHATE

Medical Condition Treated

IMIFOPLATIN is being studied specifically for the treatment of metastatic castration-resistant prostate cancer (mCRPC)[1]. This is an advanced form of prostate cancer that:

  • Has spread (metastasized) to other parts of the body beyond the prostate
  • Continues to grow despite treatments that lower testosterone levels (castration)

This type of prostate cancer is particularly challenging to treat, as it has become resistant to standard hormone therapies[1].

How IMIFOPLATIN Works

While the exact mechanism of action for IMIFOPLATIN is not fully described in the provided information, as a platinum-containing therapy, it likely works by damaging the DNA of cancer cells, preventing them from dividing and ultimately leading to their death[1]. This approach is similar to other platinum-based chemotherapy drugs, but IMIFOPLATIN may have unique properties that researchers hope will make it effective against resistant forms of prostate cancer.

Current Clinical Trial

IMIFOPLATIN is currently being studied in a Phase 1 clinical trial[1]. The main objectives of this trial are:

  • To determine the safe and effective dose of IMIFOPLATIN
  • To evaluate how well patients tolerate the drug
  • To assess how effective the drug is in controlling the disease

The trial is testing different dosing schedules to find the best balance between effectiveness and side effects[1]. The primary measure of effectiveness is the disease control rate at 4 months (DCR4), which refers to the percentage of patients whose cancer does not worsen during this period.

Eligibility for the Trial

The trial is open to men aged 18 and older with confirmed metastatic castration-resistant prostate cancer. Some key eligibility criteria include[1]:

  • Having received at least three prior life-prolonging therapies for metastatic disease
  • Having evidence of disease progression
  • Being in generally good health with adequate organ function
  • Not having certain other medical conditions that might interfere with the study

How IMIFOPLATIN is Administered

IMIFOPLATIN is given as an intravenous infusion, which means it’s delivered directly into the bloodstream through a vein[1]. The current trial is testing two main dosing schedules:

  • 250 mg/m² on Days 1 and 15 of each 28-day cycle
  • 360 mg/m² on Days 1 and 15 of the first cycle, then 250 mg/m² on Day 15 of subsequent cycles

Safety and Potential Side Effects

As with all cancer treatments, IMIFOPLATIN may cause side effects. The clinical trial is carefully monitoring patients for any adverse reactions[1]. While specific side effects are not listed in the provided information, patients should be aware that platinum-based therapies can sometimes cause:

  • Nausea and vomiting
  • Fatigue
  • Decreased blood cell counts
  • Kidney problems

The trial is designed to find the dose that provides the best balance between effectiveness and tolerability[1].

Future Prospects

If the current Phase 1 trial shows promising results, IMIFOPLATIN may proceed to larger clinical trials. The goal is to determine if this new drug can provide a meaningful benefit to patients with advanced prostate cancer who have limited treatment options[1]. However, it’s important to note that many drugs in early-stage trials do not ultimately receive approval, and more research is needed to fully understand the potential of IMIFOPLATIN.

Aspect Details
Drug Name Imifoplatin (PT-112)
Trial Phase Phase 1, Open-Label
Target Condition Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Administration Intravenous Infusion
Dosing Schedule 250 mg/m² or 360 mg/m² on specific days of 28-day cycles
Primary Objective Determine recommended dose and schedule for future studies
Key Eligibility Criteria Men ≥18 years, confirmed mCRPC, ≥3 prior therapies, disease progression
Main Endpoints Disease Control Rate at 4 months, Safety, Pharmacokinetics

FAQ

  • What is Imifoplatin and how does it work? Imifoplatin, also known as PT-112, is a new drug being tested for advanced solid tumors, especially metastatic castration-resistant prostate cancer. It's a platinum-based therapy that may work differently from other cancer treatments, but its exact mechanism is still being studied in clinical trials.
  • Who is eligible for the Imifoplatin clinical trial? The trial is open to men 18 years or older with confirmed metastatic castration-resistant prostate cancer. Patients must have received at least three prior life-prolonging therapies and show evidence of disease progression. They also need to meet specific health criteria and have adequate organ function.
  • How is Imifoplatin administered in the trial? Imifoplatin is given as an intravenous infusion. The trial is testing different dosing schedules, including 250 mg/m² on days 1 and 15 of each 28-day cycle, or 360 mg/m² on days 1 and 15 of the first cycle, followed by 250 mg/m² on day 15 of subsequent cycles.
  • What are the main goals of the Imifoplatin clinical trial? The primary goal is to determine the recommended dose and schedule for Imifoplatin in future studies. The trial also aims to assess its safety, how the body processes the drug (pharmacokinetics), and its effects on the cancer, including tumor response and survival rates.
  • How long does the Imifoplatin clinical trial last? The trial duration varies for each patient. Participants receive treatment in 28-day cycles and continue as long as they benefit from the treatment and don't experience severe side effects. Regular assessments are conducted throughout the study to monitor the patient's response and overall health.

Ongoing Clinical Trials on Imifoplatin

  • Study on the Safety and Effects of PT-112 for Patients with Advanced Prostate Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    France

Glossary

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC): A type of advanced prostate cancer that has spread beyond the prostate to other parts of the body and continues to grow despite treatments that lower testosterone levels.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Pharmacokinetics: The study of how the body processes a drug, including its absorption, distribution, metabolism, and excretion.
  • Disease Control Rate (DCR): The percentage of patients whose cancer shrinks or remains stable in response to treatment.
  • RECIST Criteria: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Circulating Tumor Cells (CTCs): Cancer cells that have detached from a tumor and are found in the bloodstream.
  • Prostate-Specific Antigen (PSA): A protein produced by the prostate gland; elevated levels may indicate prostate cancer or other prostate conditions.
  • GnRH Analog: A type of hormone therapy used to suppress testosterone production in prostate cancer treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-pt-112-for-patients-with-advanced-prostate-cancer/