Expanded Access Program of Surufatinib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04814732|
Expanded Access Status : Available
First Posted : March 24, 2021
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment|
|Neuroendocrine Tumors||Drug: Surufatinib|
Prior to any assessments, all subjects must provide a signed ICF. Prior to inclusion in the program, the patients must undergo all appropriate screening procedures to check for eligibility.
Once eligibility is confirmed, patients will receive treatment with surufatinib 300mg, orally (PO), daily (QD). All patients will undergo continuous monitoring for safety until the end of treatment.
There is no pre-defined duration of treatment for each patient. Patients will be treated until progressive disease (as defined by treating physician), unacceptable toxicity, death, withdrawal from program, the treatment becomes commercially available, or halting of product development.
A follow-up clinic visit is recommended for all patients approximately 30 days after last dose of treatment to complete the final safety assessments, as applicable.
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients, Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors|
- Drug: Surufatinib
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814732
|Contact: Leslie Callahan, BSN,MS||+1 973-826-5578||ExpandedAccess@hmplglobal.com|
|Contact: Monica Gonzalez, MS||210-508-5059||Monica.Gonzalez@syneoshealth.com|
|Study Chair:||John Kauh, MD||Hutchison Medipharma Limited|