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Phase II Study of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma With FGFR2 Fusion

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: NCT04353375
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 tartrate in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusion.

Condition or disease Intervention/treatment Phase
Advanced Bile Duct Cancer Drug: HMPL-453 Phase 2

Detailed Description:
Around 29 patients with metastatic or local advanced intrahepatic cholangiocarcinoma with FGFR2 fusion, who have failed at least one systemic therapy will be treated with HMPL-453 till disease progression or death.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Multicenter, Open-label Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma With FGFR2 Fusion
Estimated Study Start Date : July 30, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: HMPL-453
HMPL-453 150mg QD
Drug: HMPL-453
HMPL-453 150mg QD




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes first ]
    Evaluating ORR of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma


Secondary Outcome Measures :
  1. Desease control rate (DCR) at week 12 [ Time Frame: Measured up to 6 months after the last patient has been enrolled or all patients have finished their last PFS follow up, whichever comes first ]
    Evaluating DCR of week 12 of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma

  2. 12 weeks DCR [ Time Frame: Measured on 12 weeks ]
    Evaluating 12 weeks DCR of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma

  3. TTR [ Time Frame: 4 weeks ]
    Evaluating TTR of HMPL-453 in patients who achieved partial response or complete response according to mRECIST 1.1

  4. DoR [ Time Frame: 20 weeks ]
    Evaluating DoR of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma

  5. 12 weeks PFS [ Time Frame: Measured on 12 weeks ]
    Evaluating 12 weeks PFS of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma

  6. PFS [ Time Frame: 20 weeks ]
    Evaluating PFS of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma

  7. OS [ Time Frame: 30 weeks ]
    Evaluating OS of HMPL-453 in patients with advanced intrahepatic cholangiocarcinoma



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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

Inclusion Criteria:

  1. Signed written informed consent;
  2. 18 years of age or older;
  3. Histologically diagnosed as intrahepatic cholangiocarcinoma with FGFR2 fusion, and cannot be cured radically;
  4. Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression or intolerable toxicity;
  5. Measurable disease by RECIST version 1.1 criteria;
  6. ECOG performance status ≤ 1.

Exclusion Criteria:

  1. Previous treatment with selected FGFR2 inhibitors;
  2. Received systemic anti-cancer therapy within 2 weeks of the first dose of HMPL-453;
  3. Major surgery within 4 weeks of the first dose of HMPL-453;
  4. Use of a strong inducer or inhibitor of cytochrome P450 3A4 (CYP3A4) within 1 week of the first dose of HMPL-453;
  5. Inadequate liver or kidney insufficiency;
  6. Clinical significant liver diseases;
  7. Known human immunodeficiency virus (HIV) infection;
  8. Previous history of retinal detachment;
  9. Unable to swallow the study drug.

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): NCT04353375


Contacts
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Contact: Chen Yu +86 21 2067 1890 cheny@hmplglobal.com
Contact: Jessica Zhang +86 21 2067 3063 Jessicaz@hmplglobal.com

Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Jianming Xu Beijing People's Liberation Army 307 Hospital
Study Chair: Weiguo Su, PhD Hutchison MediPharma Ltd
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04353375    
Other Study ID Numbers: 2019-453-00CH2
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchison Medipharma Limited:
FGFR
Additional relevant MeSH terms:
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Cholangiocarcinoma
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Adenocarcinoma
Carcinoma
Biliary Tract Diseases
Digestive System Diseases