Clinical trial · Expanded Access
Expanded Access Program of Surufatinib
An Expanded Access Program of Surufatinib for Patients With Advanced or Metastatic Neuroendocrine Tumors
NCT04814732CI-TRIAL-00076009no longer availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This treatment protocol is intended to provide early access of surufatinib to patients with locally advanced or metastatic NETs for whom, in the opinion of their treating physician, other treatment options or surufatinib clinical trials in this indication are unsuitable. This EAP is currently available in the US only.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surufatinib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically documented, well differentiated, locally advanced or metastatic NETs 2. The patient or parent/legal guardian (as appropriate) is willing and able to provide informed consent, and where required, the patient is willing to provide assent 3. ≥12 years of age 4. In the opinion of the patient's treating physician, other treatment options or clinical trials in this indication are unsuitable 5. Patient has adequate bone marrow and organ function 6. Urine dipstick ≤1+ for proteinuria or ≤30 mg/dL in urinalysis, 7. ECOG ≤2 for adult patients (≥18 years of age), Karnofsky ≥60 for patients \>16 and \<18 years of age, and Lansky ≥60 for pediatric patients ≤16 years of age 8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and partner) to use a highly effective form(s) of contraception Exclusion Criteria: 1. Uncontrollable hypertension, as defined by local institution 2. Gastrointestinal disease or condition that the physician suspects may affect drug absorption 3. History or presence of a serious hemorrhage 4. Clinically significant cardiovascular disease 5. Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy 6. High risk of bleeding at screening due to tumor invasion 7. Arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing or thromboembolic events (including stroke and/or transient ischemic attack) within 6 months prior to first dosing 8. Received treatment with anticancer therapy, including investigational therapy, within 7 days or 5 half-lives (whichever is longer) 9. Received prior treatment with surufatinib 10. Inability to take medication orally 11. Any other clinically significant comorbidities that, in the judgment of the treating physician, could predispose the patient to safety risks
References
Publications (0)
Data not yet available
No reference posted for this study.