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Trial record 1 of 1 for:    NCT02549937
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A Multi-Center, Open-Label Study of Surufatinib (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 : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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.


Condition or disease Intervention/treatment Phase
Tumors Drug: surufatinib Phase 1 Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escalation 50 mg
Escalation cohort at 50 mg/day
Drug: surufatinib
orally once daily (QD) in patients with advanced solid tumor.
Other Names:
  • HMPL-012
  • sulfatinib

Experimental: Escalation 100mg
Escalation cohort at 100 mg/day
Drug: surufatinib
orally once daily (QD) in patients with advanced solid tumor.
Other Names:
  • HMPL-012
  • sulfatinib

Experimental: Escalation 200 mg
Escalation cohort at 200 mg/day
Drug: surufatinib
orally once daily (QD) in patients with advanced solid tumor.
Other Names:
  • HMPL-012
  • sulfatinib

Experimental: Escalation 300 mg
Escalation cohort at 300 mg/day
Drug: surufatinib
orally once daily (QD) in patients with advanced solid tumor.
Other Names:
  • HMPL-012
  • sulfatinib

Experimental: Escalation 400 mg
Escalation cohort at 400 mg/day
Drug: surufatinib
orally once daily (QD) in patients with advanced solid tumor.
Other Names:
  • HMPL-012
  • sulfatinib

Experimental: Expansion
Subjects will receive RP2D surufatinib daily treatment continuously with every 28-day treatment cycle. Four expansion cohorts will enroll BTC, pNET, EP-NET, and STS patients, respectively.
Drug: surufatinib
orally once daily (QD) in patients with advanced solid tumor.
Other Names:
  • HMPL-012
  • sulfatinib




Primary Outcome Measures :
  1. Incidence of DLT [ Time Frame: From date of enrollment through end of Cycle 1, up to 28 days ]
    The primary outcome during dose escalation will be the incidence rate of DLTs

  2. Progression Free Survival (PFS) rate [ Time Frame: From date of enrollment to progression or death up to 18 months ]
    The primary outcome during dose expansion will be the PFS rate for each cohort


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Objective response rate [ Time Frame: within 30 days after the last dose ]
    the proportion of subjects who have a Complete Response or Partial Response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Fully understand the study and voluntarily sign the informed consent form;
  • At least 18 years old;
  • Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type during the dose escalation phase, that has progressed on available standard systemic therapy, and for whom no effective therapy or standard of care exists; and locally advanced or metastatic BTC that has progressed on standard first-line chemotherapy; locally advanced or metastatic pNET that has progressed on everolimus, sunitinib or both; locally advanced or metastatic EP-NET that has progressed on everolimus; advanced STS that has progressed on at least one line of standard therapy or refused standard frontline cytotoxic chemotherapy during the expansion phase;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Hypertension that is not controlled by antihypertension medication, defined as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
  • History or presence of digestive tract diseases, including active gastric/duodenal ulcer or ulcerative colitis, or active hemorrhage of an unresected gastrointestinal tumor, or an evaluation by investigators of having any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation;
  • History or presence of serious hemorrhage , hemoptysis or hematemesis within 3 months or a thromboembolic event (including Deep Vein Thrombosis (DVT), stroke and/or transient ischemic attack) within 6 months;
  • Patients with squamous Non Small Cell Lung Cancer (NSCLC) should be excluded;
  • Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris or coronary artery bypass grafting, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment or left ventricular ejection fraction (LVEF) < 50%;
  • Systemic anti-neoplastic therapies within 4 weeks prior to the initiation of investigational treatment, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
  • Palliative radiotherapy for bone metastasis/lesion within 2 weeks;
  • Known Human immunodeficiency virus (HIV) infection;
  • Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis;
  • Women who are pregnant or lactating;
  • Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; Subjects requiring steroids within 4 weeks prior to start of study treatment will be excluded;
  • Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
  • Received investigational treatment in another clinical study within 4 weeks prior to the initiation of investigational treatment;
  • Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at high risk.

Information from the National Library of Medicine

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


Contacts
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Contact: Alberto Fernandez +1 201 218 0368 albertof@hmplglobal.com

Locations
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United States, California
City of Hope Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 91010
Contact: Daneng Li, MD         
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Denver, Colorado, United States, 80218
Contact: Allen Cohn, MD         
SCRI at HealthONE Recruiting
Denver, Colorado, United States, 80218
Contact: Gerald Falchook, MD         
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Judy Wang, MD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Max Sung, MD         
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10072
Contact: Sujana Moova, MD         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Erika Hamilton, MD         
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Scott Paulson, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Arvind Dasari, MD         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Study Director: John Kauh, MD Hutchison MediPharma
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02549937    
Other Study ID Numbers: 2015-012-00US1
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchison Medipharma Limited:
biliary
pancreatic
neuroendocrine
carcinoid
PNET
EP-NET
extrapancreatic
sarcoma
soft tissue sarcoma
STS
BTC