Ignite Creation Date:
2024-05-06 @ 7:30 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02549937
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2015-07-13
Brief Title:
A Multi-Center Open-Label Study of Surufatinib HMPL-012 in Patients With Advanced Solid Tumors
Sponsor:
Hutchmed
Organization:
Hutchmed
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04814732
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 33 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 50100 200 300 and 400 mgday
Expansion phase
Approximately 115 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 investigators discretion for a favorable benefit to risk balance
The study consists of two phases
Dose escalation phase - A 33 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 50100 200 300 and 400 mgday
Expansion phase
Approximately 115 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 investigators discretion for a favorable benefit to risk balance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None