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Rigosertib Sodium

Rigosertib Sodium is an investigational drug being studied in clinical trials for various types of cancer and blood disorders. This article summarizes key information about ongoing clinical trials evaluating the safety, efficacy, and optimal dosing of rigosertib in conditions like myelodysplastic syndromes (MDS), leukemias, and solid tumors. The trials are exploring both intravenous and oral formulations of rigosertib across different patient populations.

Table of Contents

What is Rigosertib?

Rigosertib sodium, also known as ON 01910.Na, is an investigational anti-cancer drug that is being studied for its potential to treat various types of cancer and blood disorders[1]. It is a novel small molecule that targets cellular signaling pathways involved in cancer cell growth and survival[2].

Conditions Treated

Rigosertib is being investigated for the treatment of several conditions, including:

  • Myelodysplastic Syndromes (MDS): A group of blood disorders where the bone marrow doesn’t produce enough healthy blood cells[3]
  • Acute Myeloid Leukemia (AML): A type of blood cancer that starts in the bone marrow[4]
  • Acute Lymphoblastic Leukemia (ALL): A type of blood cancer that affects lymphocytes, a type of white blood cell[4]
  • Chronic Myeloid Leukemia (CML): A slow-growing type of blood cancer that starts in the bone marrow[4]
  • Chronic Lymphocytic Leukemia (CLL): A type of cancer that affects lymphocytes and progresses slowly[4]
  • Solid Tumors: Various types of cancers that form solid masses[1]

Administration

Rigosertib can be administered in two main forms:

  1. Intravenous (IV) Infusion: Rigosertib is given as a continuous infusion over 24 to 72 hours, typically every two weeks[1][3]. The dosage is usually based on the patient’s body surface area (BSA) and can range from 650 mg/m² to 2400 mg/m² per day[4].
  2. Oral Capsules: Rigosertib is also available in oral form, typically given as 560 mg in the morning and 280 mg in the afternoon, taken on an empty stomach[5]. The oral form is often given for 21 consecutive days of a 21-day cycle[6].

Efficacy

Clinical trials have shown promising results for rigosertib in treating various conditions:

  • In patients with high-risk MDS who had failed or progressed on hypomethylating agent therapy, rigosertib showed potential to improve overall survival[3].
  • For low-risk MDS patients who were transfusion-dependent and refractory to erythropoiesis-stimulating agents, oral rigosertib demonstrated the potential to reduce transfusion dependency[6].
  • In studies involving patients with various types of leukemia, rigosertib showed anti-tumor activity and potential for improving blood cell counts[4].

Safety and Side Effects

As with any medication, rigosertib can cause side effects. Common adverse events reported in clinical trials include:

  • Fatigue
  • Nausea and vomiting
  • Diarrhea
  • Decreased blood cell counts (which can lead to increased risk of infection, bleeding, or anemia)
  • Urinary symptoms (such as dysuria or difficulty urinating)[5]

The severity and frequency of side effects can vary depending on the dosage and method of administration. Researchers are continuously monitoring and evaluating the safety profile of rigosertib in ongoing clinical trials[1][3].

Ongoing Research

Rigosertib is still under investigation, and numerous clinical trials are ongoing to further evaluate its efficacy and safety in various cancer types and blood disorders. These studies aim to determine the optimal dosing regimens, identify the most responsive patient populations, and assess long-term outcomes[1][3][6].

Researchers are also studying the drug’s mechanism of action, its effects on specific cellular pathways, and its potential combinations with other cancer therapies[2].

As an investigational drug, rigosertib is not yet approved for general use. Patients interested in accessing rigosertib should consult with their healthcare providers about the possibility of participating in clinical trials.

Aspect Details
Drug Name Rigosertib Sodium (also known as ON 01910.Na)
Formulations Intravenous infusion, Oral capsules
Conditions Studied Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Advanced solid tumors
Key Trial Objectives Determine safety, optimal dosing, pharmacokinetics, efficacy
Common Endpoints Adverse events, drug concentration in plasma, hematologic improvement, overall response rate, duration of response
Dosing Strategies IV: 24-120 hour continuous infusions, various doses (e.g., 650-4450 mg/m2)
Oral: Twice or thrice daily dosing, various doses (e.g., 560 mg BID)
Patient Populations Refractory/relapsed leukemias, high-risk MDS, transfusion-dependent low-risk MDS, advanced solid tumors

FAQ

  • What is rigosertib sodium? Rigosertib sodium is an investigational anti-cancer drug being studied for the treatment of various blood cancers and solid tumors. It is being evaluated in both intravenous and oral formulations in clinical trials.
  • What conditions is rigosertib being studied for? Rigosertib is being studied for conditions like myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and advanced solid tumors.
  • How is rigosertib administered in clinical trials? Rigosertib is being studied in both intravenous and oral formulations. Intravenous rigosertib is typically given as continuous infusions over 24-120 hours. Oral rigosertib is given as capsules, usually twice or three times daily.
  • What are the main goals of the rigosertib clinical trials? The main goals are to determine the safety, optimal dosing, and efficacy of rigosertib. Trials are evaluating side effects, pharmacokinetics, and clinical responses like reductions in transfusion needs or improvements in blood counts.
  • Are there any common side effects of rigosertib reported in trials? While specific side effects vary between trials, some reported effects include nausea, vomiting, diarrhea, fatigue, and changes in blood cell counts. The trials closely monitor patients for any adverse events to determine the drug's safety profile.

Ongoing Clinical Trials on Rigosertib Sodium

  • Study on Rigosertib Sodium for Patients with Recessive Dystrophic Epidermolysis Bullosa and Advanced Squamous Cell Carcinoma

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

Glossary

  • Myelodysplastic Syndromes (MDS): A group of blood disorders where the bone marrow does not produce enough healthy blood cells. MDS can progress to acute myeloid leukemia in some cases.
  • Acute Myeloid Leukemia (AML): A type of blood cancer that starts in the bone marrow and often moves quickly into the blood. It affects the myeloid line of blood cells.
  • Acute Lymphocytic Leukemia (ALL): A type of blood cancer that starts in the bone marrow and often moves quickly into the blood. It affects the lymphoid line of blood cells.
  • Chronic Myeloid Leukemia (CML): A type of blood cancer that starts in the bone marrow and develops slowly. It affects the myeloid line of blood cells.
  • Chronic Lymphocytic Leukemia (CLL): A type of blood cancer that starts in the bone marrow and develops slowly. It affects the lymphoid line of blood cells.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it is absorbed, distributed, metabolized, and excreted.
  • 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.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Erythropoiesis-stimulating agents (ESAs): Medications that stimulate the bone marrow to produce more red blood cells.
  • Transfusion-dependent: A condition where a patient requires regular blood transfusions to maintain adequate blood cell levels.

References

  1. https://clinicaltrials.gov/study/NCT01538537
  2. https://clinicaltrials.gov/study/NCT01538563
  3. https://clinicaltrials.gov/study/NCT01928537
  4. https://clinicaltrials.gov/study/NCT00854646
  5. https://clinicaltrials.gov/study/NCT01168011
  6. https://clinicaltrials.gov/study/NCT01904682