Patients With High-grade Pancreatic Neuroendocrine Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

Lurbinectedin 4 MG Injection [Zepzelca]: Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity.

Study summary

* Pancreatic neuroendocrine tumor (pNET) is a rare form of cancer. Treatment options such as hormonal therapy (octreotide) and targeted therapy (everolimus and sunitinib) may be considered for grade 1 or 2 pNETs; however, cytotoxic chemotherapy is essential in cases with grade 3 pNETs or pNECs.
* Cisplatin/etoposide remains the treatment of choice for high-grade pNET/pNEC. Other irinotecan-based therapies, such as FOLFIRI (cisplatin/irinotecan), FOLFOX, and temozolomide ± capecitabine, have been employed; however, a standard of care remains to be established.

Eligibility

Primary outcome measure(s)

• The overall response rate — From date of first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24months"
  The proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by the investigators according to the Response Evaluation Criteria in Solid Tumors

Trial sites (1)

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