Tumors Clinical Trial
Official title:
A Multi-Center, Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Surufatinib (HMPL-012), Previously Named Sulfatinib in Advanced Solid Tumors
Primary Objective Dose Escalation: To evaluate the safety and tolerability of surufatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D). Primary Objective Dose Expansion: To evaluate the anticancer activity of surufatinib in patients with advanced Biliary Tract Cancer (BTC), patients with advanced pancreatic neuroendocrine tumors (pNETs), patients with locally advanced, unresectable, metastatic extra-pancreatic neuroendocrine tumors (EP-NETs), and patients with soft tissue sarcomas (STS) treated at a dose of 300 mg QD. Secondary Objective: To evaluate the pharmacokinetic profile of multiple dose surufatinib in patients with advanced solid tumors and to evaluate the anti cancer activity of surufatinib in patients with advanced solid tumors.
The study is an open-label, dose escalation and expansion clinical trial of surufatinib orally once daily (QD) in patients with advanced solid tumors. The study consists of two phases: Dose escalation phase - A 3+3 design will be used for this portion of the study. - Approximately 15 to 35 evaluable patients will be enrolled. The actual number of patients depends on the Dose-limiting toxicity (DLT) situation as well as the RP2D dose level reached in this trial. - The trial will approximately evaluate five surufatinib dose levels at 50,100, 200, 300 and 400 mg/day. Expansion phase: Approximately 105 patients will be enrolled into one of four open-label treatment arms during this phase: at least 30 patients with advanced BTC that has progressed on standard first-line chemotherapy will be assigned to Arm A, at least 15 patients with advanced pNET that has progressed on either everolimus, sunitinib, or both will be assigned to Arm B, at least 15 patients with advanced EP-NET that has progressed on everolimus will be assigned to Arm C, and at least 45 patients with Soft Tissue Sarcoma will be assigned to Arm D. Subjects enrolled in this phase are to be evaluated for the safety, tolerability and pharmacokinetic (PK) characteristics to confirm the selected surufatinib dose. Subjects will receive surufatinib daily treatment continuously with every 28-day treatment cycle until disease progression, death, or intolerable toxicity at the investigator's discretion for a favorable benefit to risk balance. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT01562626 -
Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00435669 -
A Phase I Study to Determine Absorption, Distribution, Metabolism, and Elimination of a Single Radiolabeled Dose of Brivanib (BMS-582664)
|
Phase 1 | |
| Completed |
NCT00375245 -
Rapamycin With Grapefruit Juice for Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00400023 -
A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00372437 -
A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine
|
Phase 1/Phase 2 | |
| Completed |
NCT00395434 -
Safety Study of Increasing Doses of Combretastatin in Combination With Bevacizumab (Avastin) in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00410696 -
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
|
Phase 2 | |
| Recruiting |
NCT00553033 -
Laparoscopic Liver Resection
|
N/A | |
| Completed |
NCT00248404 -
NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)
|
Phase 1/Phase 2 | |
| Completed |
NCT00207103 -
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00222443 -
Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
|
Phase 1 | |
| Terminated |
NCT03251924 -
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05103969 -
Cohort of Tumors With POLE/D1 Mutation
|
||
| Completed |
NCT00446446 -
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
|
Phase 2 | |
| Completed |
NCT02275910 -
Phase 1 Study of E7090 in Subjects With Solid Tumor
|
Phase 1 | |
| Terminated |
NCT02271516 -
to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
|
Phase 1 | |
| Completed |
NCT01448759 -
Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel
|
N/A | |
| Terminated |
NCT01081808 -
Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00389480 -
Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies
|
Phase 1 | |
| Completed |
NCT00398814 -
Phase I Study of Perifosine + Sorafenib for Patients With Advanced Cancers
|
Phase 1 |