You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR SAMARIUM SM-153 LEXIDRONAM PENTASODIUM


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Samarium Sm-153 Lexidronam Pentasodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00245011 ↗ Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma Completed National Cancer Institute (NCI) Phase 2 2004-10-01 RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
NCT00245011 ↗ Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma Completed Sidney Kimmel Comprehensive Cancer Center Phase 2 2004-10-01 RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
NCT00245011 ↗ Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma Completed Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Phase 2 2004-10-01 RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
NCT00316940 ↗ Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma Completed Oncotherapeutics Phase 1 2005-12-01 RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also make tumor cells more sensitive to radiation. Giving samarium 153 together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of samarium 153 when given together with bortezomib in treating patients with relapsed or refractory multiple myeloma.
NCT00365105 ↗ Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer Completed National Cancer Institute (NCI) Phase 3 2006-07-11 RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
NCT00365105 ↗ Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer Completed NRG Oncology Phase 3 2006-07-11 RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
NCT00365105 ↗ Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer Completed Radiation Therapy Oncology Group Phase 3 2006-07-11 RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Samarium Sm-153 Lexidronam Pentasodium

Condition Name

Condition Name for Samarium Sm-153 Lexidronam Pentasodium
Intervention Trials
Multiple Myeloma and Plasma Cell Neoplasm 4
Pain 2
Breast Cancer 1
Lung Cancer 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Samarium Sm-153 Lexidronam Pentasodium
Intervention Trials
Plasmacytoma 4
Neoplasms, Plasma Cell 4
Multiple Myeloma 4
Prostatic Neoplasms 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Samarium Sm-153 Lexidronam Pentasodium

Trials by Country

Trials by Country for Samarium Sm-153 Lexidronam Pentasodium
Location Trials
United States 39
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Samarium Sm-153 Lexidronam Pentasodium
Location Trials
Maryland 3
Minnesota 3
Florida 2
California 2
Kentucky 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Samarium Sm-153 Lexidronam Pentasodium

Clinical Trial Phase

Clinical Trial Phase for Samarium Sm-153 Lexidronam Pentasodium
Clinical Trial Phase Trials
Phase 3 1
Phase 2 1
Phase 1/Phase 2 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Samarium Sm-153 Lexidronam Pentasodium
Clinical Trial Phase Trials
Completed 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Samarium Sm-153 Lexidronam Pentasodium

Sponsor Name

Sponsor Name for Samarium Sm-153 Lexidronam Pentasodium
Sponsor Trials
National Cancer Institute (NCI) 5
Mayo Clinic 3
Sidney Kimmel Comprehensive Cancer Center 1
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Samarium Sm-153 Lexidronam Pentasodium
Sponsor Trials
Other 7
NIH 5
Industry 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Samarium SM-153 Lexidronam Pentasodium: Clinical Trials, Market Analysis, and Projections

Overview of Samarium SM-153 Lexidronam Pentasodium

Samarium SM-153 lexidronam pentasodium, marketed under the brand name Quadramet, is a radiopharmaceutical used to relieve bone pain associated with osteoblastic skeletal metastases. It is a chelated complex of the samarium isotope and EDTMP, which concentrates in areas of high bone turnover, such as sites of metastases, to provide pain relief[5].

Clinical Trials Update

Current Status and Phases

Samarium SM-153 lexidronam pentasodium has undergone various clinical trials to evaluate its efficacy and safety in different patient populations.

  • Phase 1 and 2 Trials: These trials have focused on the drug's use in combination with other treatments. For example, a Phase 1 trial combined samarium-153 with total androgen suppression, bicalutamide, and goserelin acetate in patients with prostate cancer. Another Phase 2 trial evaluated the use of samarium-153 in conjunction with stem cell transplantation[4].
  • Specific Studies: A notable Phase 3 trial was not specifically mentioned, but earlier phases have shown promising results. For instance, a study involving the Radiation Therapy Oncology Group (RTOG 0622) included samarium-153 treatment as part of the protocol, emphasizing its integration into comprehensive cancer treatment plans[3].

Efficacy and Safety

Clinical trials have demonstrated the efficacy of samarium-153 lexidronam pentasodium in relieving bone pain. The drug has shown to provide pain relief as early as one week in the majority of patients. However, it also comes with side effects, including a decrease in white blood cell and platelet counts, which typically nadir 3 to 5 weeks after administration[1].

Ongoing and Future Trials

While specific ongoing trials are not detailed in the available sources, the continued interest in radiopharmaceuticals for cancer treatment suggests that further research is likely. Future trials may focus on optimizing dosages, exploring combination therapies, and expanding the drug's indications to other types of cancer.

Market Analysis

Cost-Effectiveness

Studies have shown that samarium-153 lexidronam pentasodium is cost-effective compared to conventional therapies for managing bone pain in patients with prostate cancer and bone metastases. A cost-effectiveness analysis revealed that the cost of pain control per patient was significantly lower with samarium-153 therapy (€5,595.52) compared to conventional therapy (€12,515.39)[2].

Market Demand

The demand for effective treatments for bone pain in cancer patients is high, given the prevalence of bone metastases in various cancers. Samarium-153 lexidronam pentasodium fills a critical need by providing a targeted and relatively quick-acting solution for pain relief.

Competitive Landscape

The radiopharmaceutical market includes other agents like radium-223, which also targets bone metastases but with different mechanisms and indications. Samarium-153 lexidronam pentasodium's unique profile, including its medium-energy beta particles and imageable gamma photons, positions it as a valuable option in the treatment arsenal[4].

Market Projections

Growth Potential

Given its cost-effectiveness and efficacy, samarium-153 lexidronam pentasodium is likely to see continued growth in the market. As cancer treatment protocols evolve, the integration of radiopharmaceuticals like Quadramet is expected to increase.

Expanding Indications

Future market growth may also come from expanding the drug's indications to other types of cancer with bone metastases. Clinical trials exploring its use in breast cancer, lung cancer, and other malignancies could further broaden its market reach.

Regulatory Environment

The drug's approval in the US since 1997 and its ongoing use in various countries suggest a favorable regulatory environment. Continued regulatory support and potential approvals in additional regions will be crucial for market expansion[5].

Key Takeaways

  • Efficacy: Samarium SM-153 lexidronam pentasodium is effective in relieving bone pain in patients with osteoblastic skeletal metastases.
  • Cost-Effectiveness: The drug is cost-effective compared to conventional therapies for managing bone pain.
  • Clinical Trials: Ongoing and future trials are expected to optimize its use and explore new indications.
  • Market Demand: High demand for effective treatments for bone pain in cancer patients supports market growth.
  • Competitive Landscape: The drug's unique profile positions it well in the radiopharmaceutical market.

FAQs

What is Samarium SM-153 Lexidronam Pentasodium used for?

Samarium SM-153 lexidronam pentasodium is used to relieve bone pain associated with osteoblastic skeletal metastases in cancer patients.

How does Samarium SM-153 Lexidronam Pentasodium work?

The drug is a chelated complex of samarium isotope and EDTMP, which concentrates in areas of high bone turnover, such as sites of metastases, to provide pain relief through radiation.

What are the common side effects of Samarium SM-153 Lexidronam Pentasodium?

Common side effects include a decrease in white blood cell and platelet counts, which typically nadir 3 to 5 weeks after administration.

Is Samarium SM-153 Lexidronam Pentasodium cost-effective?

Yes, studies have shown that it is cost-effective compared to conventional therapies for managing bone pain in patients with prostate cancer and bone metastases.

What is the current market status of Samarium SM-153 Lexidronam Pentasodium?

The drug is approved in the US and other countries and is expected to see continued growth in the market due to its efficacy and cost-effectiveness.

Sources

  1. EMA: Quadramet, INN-Samarium [153Sm] lexidronam pentasodium - EPAR - Product Information.
  2. PubMed: Cost-effectiveness analysis of samarium [153Sm-EDTMP] (Quadramet) for the treatment of pain in patients with prostate cancer and bone metastases.
  3. RTOG 0622: Radiation Therapy Oncology Group - RTOG 0622.
  4. Patsnap: Samarium SM-153 Lexidronam Pentasodium.
  5. DrugBank: Samarium (153Sm) lexidronam - DrugBank.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.