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Copanlisib Dihydrochloride

Copanlisib Dihydrochloride, also known as Aliqopa, is an investigational drug being studied in various clinical trials for its potential in treating different types of cancer. This article explores the ongoing research into Copanlisib Dihydrochloride’s efficacy and safety in combination with other treatments for conditions such as lymphomas, breast cancer, and other advanced solid tumors.

Table of Contents

What is Copanlisib Dihydrochloride?

Copanlisib Dihydrochloride, also known as Copanlisib, is an investigational anti-cancer drug that belongs to a class of medications called PI3K inhibitors. It is being studied for its potential to treat various types of cancers, particularly those that have not responded well to other treatments or have come back after initial treatment[1][2].

This drug is also known by several other names, including:

  • Aliqopa
  • BAY 80-6946 Dihydrochloride
  • BAY-80-6946 Dihydrochloride
  • 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2)
These alternative names may be used in medical literature or by healthcare providers[3].

How Does Copanlisib Dihydrochloride Work?

Copanlisib Dihydrochloride works by blocking certain enzymes in cancer cells that are needed for their growth. Specifically, it targets proteins called PI3K (phosphatidylinositol-3-kinase), which are involved in cell growth and survival. By inhibiting these proteins, Copanlisib may help to stop or slow down the growth of cancer cells[1].

This mechanism of action makes Copanlisib particularly interesting for cancers that have mutations in the PI3K pathway, as these cancers may be more dependent on this pathway for their growth and survival[4].

What Conditions Does Copanlisib Dihydrochloride Treat?

Copanlisib Dihydrochloride is being studied for the treatment of several types of cancer, including:

  • Lymphomas: Particularly non-Hodgkin lymphoma and mantle cell lymphoma that have come back or are resistant to other treatments[1][2]
  • Solid tumors: Including advanced or metastatic cancers that have specific genetic mutations, such as PIK3CA mutations or PTEN loss[3][5]
  • Breast cancer: Especially hormone receptor-positive, HER2-negative metastatic breast cancer[6]
  • Ovarian cancer: Particularly in cases that are resistant to platinum-based chemotherapy[4]

It’s important to note that Copanlisib is still being studied for these conditions, and its effectiveness may vary depending on the specific type and stage of cancer.

How is Copanlisib Dihydrochloride Administered?

Copanlisib Dihydrochloride is typically given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein. The specific dosing schedule can vary depending on the study or treatment plan, but common schedules include:

  • Once weekly for three weeks, followed by one week off[1]
  • On days 1, 8, and 15 of a 28-day cycle[3]

The infusion usually takes about one hour. Your healthcare team will monitor you closely during and after the infusion to watch for any side effects or reactions[6].

Current Clinical Trials

Copanlisib Dihydrochloride is currently being studied in several clinical trials. These trials are investigating its use:

  • In combination with other cancer drugs, such as venetoclax for mantle cell lymphoma[1]
  • Together with immunotherapy drugs like nivolumab for various solid tumors[2][5]
  • In combination with hormone therapy and targeted therapy for breast cancer[6]
  • As part of a combination therapy for ovarian cancer that has become resistant to other treatments[4]

These trials aim to determine the safety and effectiveness of Copanlisib in different cancer types and in combination with other treatments.

Potential Side Effects

As with any medication, Copanlisib Dihydrochloride can cause side effects. Common side effects observed in clinical trials include:

  • High blood sugar levels (hyperglycemia)
  • High blood pressure (hypertension)
  • Diarrhea
  • Decreased white blood cell count, which can increase the risk of infections
  • Fatigue
  • Nausea

Your healthcare team will monitor you closely for these and other potential side effects. It’s important to report any new symptoms or changes in your health to your doctor[4][6].

Future Prospects

The ongoing clinical trials are exploring the potential of Copanlisib Dihydrochloride in various cancer types and in combination with other treatments. Researchers are particularly interested in its effectiveness in cancers with specific genetic mutations, such as PIK3CA mutations or PTEN loss[3].

If these trials show promising results, Copanlisib could become an important treatment option for patients with certain types of cancer, especially those who have not responded well to other treatments. However, more research is needed to fully understand its benefits and risks[5].

Aspect Details
Drug Name Copanlisib Dihydrochloride (also known as Aliqopa, BAY 80-6946 Dihydrochloride)
Mechanism of Action PI3K inhibitor, blocks enzymes needed for cancer cell growth
Administration Intravenous (IV) infusion, typically over 1 hour
Cancer Types Studied Mantle cell lymphoma, diffuse large B-cell lymphoma, breast cancer, ovarian cancer, advanced solid tumors
Combination Therapies Studied with venetoclax, nivolumab, ipilimumab, olaparib, abemaciclib, fulvestrant
Key Outcomes Measured Progression-free survival, overall response rate, overall survival, safety profile
Common Side Effects High blood sugar, high blood pressure, diarrhea, decreased white blood cell counts
Trial Phases Phase I, II, and III studies ongoing
Patient Populations Often focuses on relapsed or refractory cancers, or those with specific genetic mutations
Biomarker Studies Investigations into PI3K pathway mutations, PTEN loss, and other potential predictive markers

FAQ

  • What is Copanlisib Dihydrochloride? Copanlisib Dihydrochloride, also known as Aliqopa, is an investigational drug that works by blocking certain enzymes called PI3K that are involved in cancer cell growth. It is being studied in clinical trials for its potential to treat various types of cancer.
  • What types of cancer is Copanlisib Dihydrochloride being studied for? Copanlisib Dihydrochloride is being investigated for several types of cancer, including mantle cell lymphoma, diffuse large B-cell lymphoma, breast cancer, ovarian cancer, and other advanced solid tumors. It is often studied in combination with other cancer treatments.
  • How is Copanlisib Dihydrochloride administered? In most clinical trials, Copanlisib Dihydrochloride is given intravenously (through a vein) over a period of about 1 hour. The frequency of administration varies depending on the specific trial, but it's often given on certain days within treatment cycles that typically last 28 days.
  • What are some common side effects of Copanlisib Dihydrochloride? While side effects can vary, some common ones observed in clinical trials include high blood sugar, high blood pressure, diarrhea, and decreased white blood cell counts. However, it's important to note that side effects are closely monitored in clinical trials and can be managed by healthcare professionals.
  • How can I participate in a clinical trial involving Copanlisib Dihydrochloride? If you're interested in participating in a clinical trial involving Copanlisib Dihydrochloride, you should discuss this with your oncologist. They can help determine if you might be eligible for any ongoing trials and guide you through the process of enrolling if appropriate for your specific situation.

Ongoing Clinical Trials on Copanlisib Dihydrochloride

  • Study on Copanlisib and Rituximab for Patients with Marginal Zone Lymphoma Needing Treatment After Local Therapy Failure or Relapse

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Copanlisib with Rituximab and CHOP for Untreated Diffuse Large B-Cell Lymphoma in Patients Aged 18-80

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • PI3K: PI3K stands for Phosphatidylinositol-3-Kinase, which is an enzyme involved in cellular functions such as cell growth, proliferation, and survival. In cancer, PI3K can become overactive, contributing to tumor growth. Copanlisib Dihydrochloride works by inhibiting PI3K.
  • Intravenous (IV): A method of administering medication directly into a vein using a needle or tube. This allows the medication to enter the bloodstream quickly and circulate throughout the body.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage. In clinical trials, DLTs help determine the maximum tolerated dose of a new drug.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without the disease getting worse. PFS is often used to measure the effectiveness of cancer treatments in clinical trials.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment. It includes patients with partial response (tumor shrinkage) and complete response (disappearance of all signs of cancer).
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted. Understanding a drug's pharmacokinetics helps determine the best dosing and administration methods.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Biomarkers can be used to see how well the body responds to a treatment for a disease or condition.
  • PARP inhibitor: A type of targeted therapy that blocks an enzyme called poly (ADP-ribose) polymerase (PARP). PARP helps repair DNA damage in cells. Blocking PARP may help prevent cancer cells from repairing their damaged DNA, causing them to die.
  • Immunotherapy: A type of cancer treatment that helps the immune system fight cancer. It uses substances made by the body or in a laboratory to improve or restore immune system function.
  • Monoclonal antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. Monoclonal antibodies can be used alone or to carry drugs, toxins, or radioactive substances directly to cancer cells.

References

  1. https://clinicaltrials.gov/study/NCT04939272
  2. https://clinicaltrials.gov/study/NCT03484819
  3. https://clinicaltrials.gov/study/NCT05490771
  4. https://clinicaltrials.gov/study/NCT05295589
  5. https://clinicaltrials.gov/study/NCT04317105
  6. https://clinicaltrials.gov/study/NCT03939897