A Multi-Center, Open-Label Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02549937|
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : August 29, 2018
To evaluate the safety and tolerability of sulfatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D).
Secondary Objective： To evaluate the pharmacokinetic profile of multiple dose sulfatinib in patients with advanced solid tumors and to evaluate the anti cancer activity of sulfatinib in patients with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Tumors||Drug: sulfatinib||Phase 1|
The study is an open-label, dose escalation clinical trial of sulfatinib orally once daily (QD) in patients with advanced solid tumor.
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 30 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 sulfatinib dose levels at 50,100, 200, 300 and 400 mg/day.
The expansion phase will confirm the MTD with an additional 6 patients enrolled in the 400 mg/day escalation cohort. In consultation with the study investigators, observed toxicities, tolerability, and drug exposure will be evaluated.
Approximately 30 patients will be enrolled into one of two open-label treatment arms during this phase: at least 15 patients with advanced BTC that has progressed on standard ﬁrst-line chemotherapy will be assigned to Arm A, and at least 15 patients with advanced pNET that has progressed on either everolimus, sunitinib, or both will be assigned to Arm B. Subjects enrolled in this phase are to be evaluated for the safety, tolerability and pharmacokinetic (PK) characteristics to confirm the selected sulfatinib dose.
Subjects will receive sulfatinib 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics of Sulfatinib in Advanced Solid Tumors|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Dose escalation phase:five sulfatinib dose levels at 50,100, 200, 300 and 400 mg/day will be dosed; Expansion phase: Subjects will receive RP2D sulfatinib daily treatment continuously with every 28-day treatment cycle.
orally once daily (QD) in patients with advanced solid tumor.
Other Name: HMPL-012
- adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 [ Time Frame: From first dose to within 30 days after the last dose ]The safety and tolerability of sulfatinib will be evaluated based on adverse events data. Other safety parameters include physical examination, vital signs, laboratory test results (i.e., hematology, chemistry panel, and urinalysis), 12-lead electrocardiogram, and ultrasonic cardiogram.
- maximum plasma concentration calculated with Blood samples [ Time Frame: within 30 days after the first dose ]Blood samples will be taken to measure the levels of study drug.
- time to reach maximum concentration calculated with Blood samples [ Time Frame: within 30 days after the first dose ]Blood samples will be taken to measure the levels of study drug
- Objective response rate [ Time Frame: within 30 days after the last dose ]the proportion of subjects who have a Complete Response or Partial Response
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): NCT02549937
|Contact: Neo Li||+86 21-2067 3222||Jingli@hmplglobal.com|
|United States, Colorado|
|SCRI at HealthONE||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Gerald Falchook, Dr. 720-754-2610 Gerald.Falchook@scresearch.net|
|United States, Florida|
|Florida Cancer Specialists||Recruiting|
|Sarasota, Florida, United States, 34232|
|Contact: Judy Wang, Dr. 239-349-8989 firstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Erika Hamilton, Dr. 615-329-7274 email@example.com|
|Study Director:||Charlie Qi, MD||Hutchison Medi Pharma|