Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 198 for:    colon cancer | ( Map: Colorado, United States )

Phase I Evaluation of Safety, Tolerability, and Pharmacokinetics for Fruquintinib in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251378
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors and metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Metastatic Colon Cancer Drug: Fruquintinib (HMPL-013) Phase 1

Detailed Description:

The study is an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study will consist of two phases:

  • A dose escalation phase - A 3+3 design will be used for this portion of the study.
  • A dose expansion phase - Two cohorts will be evaluated in Dose Expansion. Cohort A will evaluate the MTD/RP2D in patients with advanced solid tumors. Cohort B will evaluate the MTD/RP2D in metastatic colorectal cancer patients.

Study will be conducted in up to 9 sites in the US.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Fruquintinib in Advanced Solid Tumors and Metastatic Colorectal Cancer
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : June 15, 2020

Arm Intervention/treatment
Experimental: 3 mg Dose Escalation
3 mg of Fruquintinib (HMPL-013), tablet taken daily, 3 weeks on, 1 week off
Drug: Fruquintinib (HMPL-013)
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class.
Other Name: HMPL-013

Experimental: 5 mg Dose Escalation
5 mg of Fruquintinib (HMPL-013), tablet taken daily, 3 weeks on, 1 week off
Drug: Fruquintinib (HMPL-013)
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class.
Other Name: HMPL-013

Experimental: Fruquintinib Expansion Phase
The fruquintinib dose as the recommended tolerated dose from the safety run-in arms. Dose: Fruquintinib (HMPL-013), (dose to be determined) mg, tablet taken daily, 3 weeks on, 1 week off.
Drug: Fruquintinib (HMPL-013)
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class.
Other Name: HMPL-013

Experimental: Metastatic Colorectal Cancer Expansion Phase
5 mg fruquintinib (HMPL-013) tablet taken daily, 3 weeks on, 1 week off in patients with metastatic colorectal cancer
Drug: Fruquintinib (HMPL-013)
Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class.
Other Name: HMPL-013




Primary Outcome Measures :
  1. The incidence of DLT in each cohort [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

    The primary endpoint of the dose escalation phase is the incidence of DLT in each cohort. DLT is defined as:

    • Any Grade 4 non-hematologic toxicity;
    • Any Grade 3 non-hematologic toxicity related to study drug except for nausea/vomiting, diarrhea, constipation, hypertension and electrolyte imbalances downgraded within 3 days with appropriate supportive treatment;
    • Grade 4 neutropenia lasting >3 days;
    • Grade 3 febrile neutropenia (absolute neutrophil count [ANC]) <1.0 × 109/L with a single temperature of >38.3°C or a sustained temperature of ≥38°C for more than one hour;
    • Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with bleeding;
    • Dose interruption for >14 days due to toxicity.

  2. Progression free survival (PFS) at 12 weeks [ Time Frame: From first dose of study drug through 12 weeks of treatment ]
    Primary outcome expansion: progression free survival (PFS) at 12 weeks


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: every 4 weeks or every 8 weeks depending on cohort, through study completion, an average of 6 months ]
    the proportion of 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.


Layout table for eligibility information
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 ICF;
  • ≥18years of age;

Dose Escalation Phase:

• Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type (except squamous NSCLC) that has progressed on approved systemic therapy, and for whom no effective therapy or standard of care exists. This cohort is closed to enrollment.

Dose Expansion Phase:

  • Cohort A: Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type (except squamous NSCLC), that has progressed on approved systemic therapy, and for whom no effective therapy or standard of care exists. This cohort is closed to enrollment.
  • Cohort B: Histologically or cytologically documented mCRC in patients that have progressed on, or had intolerable toxicity with at least 1 FDA-approved third-line systemic therapy (trifluridine/tipiracil or regorafenib). Patients must also have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and an anti-EGFR therapy for patients who had KRAS wild-type tumors. This cohort is currently enrolling.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

Key Exclusion Criteria:

  • Patients will be excluded from the study, if any of the following criteria is met:
  • Severe anemia, neutropenia, thrombocytopenia
  • Moderate to severe renal or hepatic impairment
  • Uncontrolled hypertension
  • Risk of, or active hemorrhage: history or presence of active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation of fistulas; or any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation within 6 months prior to screening;
  • History of a thromboembolic event (including deep vein thrombosis [DVT], pulmonary embolism, stroke and/or transient ischemic attack) within 12 months prior to screening;
  • Patients with squamous NSCLC;
  • Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) <50%;
  • Patients who have ever received a VEGFR inhibitor, except for patients with m CRC enrolled in the dose expansion phase;
  • Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
  • Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
  • Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study drug;
  • Brachytherapy (ie, implantation of radioactive seeds) within 60 days prior to the first dose of study drug;
  • Known human immunodeficiency virus (HIV) infection;
  • Known clinically significant history of liver disease, including cirrhosis, current alcohol abuse or active viral hepatitis. For patients with evidence of chronic hepatitis B (HBV), the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV who are currently on treatment, they are eligible if they have an undetectable HCV viral load;
  • Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava.;
  • 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; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded;
  • No other malignancy, except for non-melanoma skin cancer, during the 5 years prior to screening;
  • Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
  • 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 undue risk of harm based on the investigator's assessment;
  • Known hypersensitivity to fruquintinib or any of its excipients.

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): NCT03251378


Contacts
Layout table for location contacts
Contact: Alberto Fernandez 973 567 3891 albertof@hmplglobal.com
Contact: Maria Karvois 973 257 5440 maria.karvois@iqvia.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Tanios Bekaii-Saab         
Principal Investigator: Tanios Bekaii-Saab         
United States, California
California Cancer Care Associates for Research & Excellence, Inc. Recruiting
San Marcos, California, United States, 92069
Contact: Michael Kosmo    760-747-8935 ext 507      
Principal Investigator: Michael Kosmo         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Christopher Lieu         
Principal Investigator: Christopher Lieu         
United States, Florida
St. Joseph Heritage Healthcare Recruiting
Miami, Florida, United States, 33018
Contact: Thomas Stanton    707-521-3830      
Principal Investigator: Thomas Stanton         
Hem-Onc Associates of the Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact: Heather Yeckes-Rodin    772-335-0102      
Principal Investigator: Heather Yeckes-Rodin         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amit Mahipal         
Principal Investigator: Amit Mahipal         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Andrea Wang-Gillam    314-362-5740      
Principal Investigator: Andrea Wang-Gillam         
United States, Tennessee
Vanderbilt Ingram Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Jordan Berlin         
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Arvind Dasari         
Principal Investigator: Arvind Dasari         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
Layout table for investigator information
Study Director: William Schelman Hutchison MediPharma (US) Inc.

Layout table for additonal information
Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT03251378     History of Changes
Other Study ID Numbers: 2015-013-00US1
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchison Medipharma Limited:
VEGF
colorectal
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases