Yondelis Clinical Trials

Browse 7 Yondelis Medical Studies Across 22 Cities

2 Phase 3 Trial · 34 Yondelis Clinics

Reviewed by Michael Gill, B. Sc.
7 Yondelis Clinical Trials Near Me
Top Cities for Yondelis Clinical Trials
Image of Santa Monica in California.
Santa Monica
5Active Trials
Sarcoma Oncology Research Center, LLCTop Active Site
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New York
3Active Trials
Columbia University/Herbert Irving Cancer CenterTop Active Site
Yondelis Clinical Trials by Phase of Trial
Phase 1 & 2 Yondelis Clinical Trials
2Active Yondelis Clinical Trials
2Number of Unique Treatments
7Number of Active Locations
Most Recent Yondelis Clinical Trials
Clinical Trial
Began Recruiting Date
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What are Yondelis Clinical Trials?

Yondelis is the brand name of trabectedin, an antitumor medication. It is used to treat advanced ovarian cancer and soft-tissue sarcoma, which has metastasized, spreading over to other parts of the body. It is the last resort when other chemotherapy treatments have proven ineffective and surgical resection is impossible.

Manufactured and sold by Pharma Mar S.A. and Johnson and Johnson, Yondelis was FDA-approved in 2016 and is classified as an orphan drug, which means it is manufactured by government assistance because it is for such a rare condition that it is not profitable.

Side effects of Yondelis include nausea, vomiting, constipation, diarrhea, headaches, decreased appetite, and shortness of breath. Severe side effects can be fatal, including severe infections due to decreased white blood cell counts, muscle problems (rhabdomyolysis), liver problems, heart muscle problems, and capillary leak syndrome.

Why Is Yondelis Being Studied Through Clinical Trials?

For patients with metastatic ovarian cancer, the five-year survival is only 18%, and for metastatic soft tissue sarcoma, it is 16%. These low rates make drugs such as Yondelis important for slowing down the spread of cancerous cells that cannot be surgically removed, thus increasing the survival rate.

Clinical trials are currently underway to study the long-term safety of Yondelis and its effectiveness in treating other cancers that have metastases, such as breast, prostate, and pediatric cancers.

How Does Yondelis Treatment Work?

Although not completely understood, trabectedin blocks the action of DNA transcription of tumors, thus slowing down cancerous growth. However, because of its life-threatening side effects, it is prescribed as a last resort. By the time cancer has spread to other parts of the body, its benefits outweigh the risks, and it can give a patient a few more livable years.

15 mg/m2 of Yondelis is administered intravenously through a central venous line over 24 hours as there is a risk of the medication leaking from the site, which can damage cells in that area. This is repeated every three weeks until the cancer progresses or the side effects have reached an unacceptable level.

What are Some Recent Yondelis Clinical Trial Breakthroughs?

2010: This multicenter clinical trial studied the effects and safety of trabectedin in patients with advanced relapsed ovarian cancer. Sponsored by Johnson & Johnson Pharmaceutical Research & Development, 637 patients were enrolled, and the survival rates were compared between trabectedin + DOXIL with DOXIL monotherapy. Results showed that patients with limited treatment options could benefit from trabectedin, which decreased the symptoms associated with cancer, improving progression-free survival.

2021: This clinical trial studied the effectiveness of trabectedin with doxorubicin as a first-line treatment for soft tissue sarcoma leiomyosarcoma. One hundred fifty patients were enrolled in this trial, and they received 60 mg/m2 of intravenous doxorubicin, then 1.1 mg/m2 of trabectedin on day 1 and the next day pegfilgrastim, every three weeks for six consecutive cycles. Results showed that the combination drug was effective in both progression-free survival and overall survival.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: September 9th, 2023

References1 Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. doi: 10.1200/JCO.2015.62.4734. Epub 2015 Sep 14. https://pubmed.ncbi.nlm.nih.gov/263711432 Gordon EM, Sankhala KK, Chawla N, Chawla SP. Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives. Adv Ther. 2016 Jul;33(7):1055-71. doi: 10.1007/s12325-016-0344-3. Epub 2016 May 27. Review. https://pubmed.ncbi.nlm.nih.gov/272349893 Gordon EM, Sankhala KK, Chawla N, Chawla SP. Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives. Adv Ther. 2016 Jul;33(7):1055-71. doi: 10.1007/s12325-016-0344-3. Epub 2016 May 27. https://pubmed.ncbi.nlm.nih.gov/272349894 Gordon EM, Sankhala KK, Stumpf N, Tseng WW, Chawla SP. Cancer immunotherapy with sequential administration of trabectedin and nivolumab in advanced soft tissue sarcoma. Presented at the Society of Immunotherapy for Cancer/ ITOC, Prague, Czech Republic, March, 2017 5 www.accessdata.fda.gov/drugsatfda_docs (Trabectedin, Gemcitabine, Dacarbazine) 6 Maiti R. Metronomic chemotherapy. J Pharmacol Pharmacother. 2014 Jul;5(3):186-92. doi: 10.4103/0976-500X.136098. Review. https://pubmed.ncbi.nlm.nih.gov/252103987 Chawla SP, Sankhala KK, Ravicz J, Kang G, Liu S, Stumpf N, Leong B, Kim S, Arasheben S, Tseng WW, Gordon EM. Clinical experience with combination chemo-/immunotherapy using trabectedin and nivolumab for advanced soft tissue sarcoma. J Sarcoma Res. 2018; 2(1):1009. 8 Maiti R. Metronomic chemotherapy. J Pharmacol Pharmacother. 2014 Jul;5(3):186-92. doi: 10.4103/0976-500X.136098. https://pubmed.ncbi.nlm.nih.gov/252103989 Hellman MD, Gettinger SN, Goldman JW, et al. CheckMate 012: Safety and efficacy of first-line (1L) NIVOLUMAB (nivo;N) and IPILIMUMAB (ipi;I) in advanced (adv) NSCLC. J Clin Oncol 2016, 34: (suppl; abstr 3001).