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A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular Carcinoma

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: NCT04194801
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetic and efficacy of fisogatinib (formerly known as BLU-554) in combination with CS1001 in patients with locally advanced or metastatic hepatocellular carcinoma (HCC)

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Fisogatinib in combination with CS1001 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Muti-center, Open-label, Multiple-dose Phase Ib/II Study to Assess the Safety, Tolerability, Pharmacokinetics, Anti-tumor Efficacy of Fisogatinib(BLU-554) in Combination With CS1001 in Subjects With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
Experimental: Fisogatinib in combination with CS1001 Drug: Fisogatinib in combination with CS1001
During the treatment period, the subjects will be administered the study drug once every 21 days (3 cycles). Fisogatinib is taken orally (PO) once daily (QD); CS1001 is administered intravenously once every 21 days (Q3W).




Primary Outcome Measures :
  1. incidence rate of Dose-limiting Toxicity (DLT) for phase Ib [ Time Frame: Cycle 1 (21 days) ]
  2. Overall response rate (ORR) based on RECIST v1.1. for phase II [ Time Frame: 2 years ]


Information from the National Library of Medicine

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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. Voluntarily participate in the clinical study. Fully understand and get informed of this study and sign the Informed Consent Form (ICF).
  2. ≥18 years of age on day of signing the informed consent.
  3. Unresectable locally advanced or metastatic hepatocellular carcinoma as confirmed by histology or cytology.
  4. Stage B or C based on Barcelona Clinic Liver Cancer (BCLC) staging system; In case of Stage B, subject must be ineligible for surgery and/or local therapy, or has progressed after surgery and/or local therapy or refuses surgery and/or local treatment.
  5. For Phase Ib, subject has failed after or is unsuitable for the standard systemic therapy against HCC. For Phase II, subject has not previously received systemic therapy.
  6. At least one measurable lesion as evaluable by RECIST version 1.1.
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 point.
  8. A-level Child-Pugh score.
  9. Expected survival≥3 months.
  10. For Phase Ib and II, fresh or archived tumor tissue should be provided for analysis in the central laboratory.
  11. The function of the main organs was basically normal and met the requirements of the protocol.
  12. For subject with HCV infection, HCV antiviral treatment with the locally approved and available HCV antiviral therapy can be received.
  13. For subjects with HBV infection, HBV DNA ≤ 2,000 IU/ml at Screening.
  14. For female subjects of childbearing potential, serum pregnancy test must be negative within 7 days prior to randomization. Except for female subjects who have been recorded as surgically sterilized or who are postmenopausal, female subjects of childbearing potential or male subjects and their partners must agree to use effective contraception from the signature of the informed consent form (ICF) until at least 6 months after the last dose of study drug.

Exclusion criteria:

  1. tumor thrombus in the main portal vein (VP4) by imaging, involving the inferior vena cava or the heart.
  2. Prior history of hepatic encephalopathy.
  3. History of liver surgery and/or local treatment for HCC (intervention, ablation therapy, absolute alcohol injection, etc.) or radiotherapy, etc. within 4 weeks prior to first dose.
  4. Active or documented gastrointestinal bleeding within 6 months (e.g. esophageal or gastric varices, ulcer bleeding).
  5. Presence of ascites detected by physical examination or clinical symptoms caused by ascites during the screening period, or ascites that need for special treatment, such as repeated drainage, intraperitoneal drug infusion, etc.
  6. Presence of meningeal metastasis or central nervous system (CNS) metastatic lesions.
  7. Subject has clinically significant, uncontrolled cardiovascular disease.
  8. History of definite interstitial lung disease or non-infectious pneumonia except that caused by local radiotherapy; history of active tuberculosis.
  9. Any serious acute, chronic infections that require systemic antimicrobial, antifungal or antiviral therapy at screening, excluding viral hepatitis.
  10. Malabsorption syndrome or inability to take the study drug orally for other reasons.
  11. Had primary malignancies other than HCC within 5 years.
  12. Subject has had major surgery within 4 weeks prior to first dose (procedures such as central venous cannulation, biopsy, and feeding tube placement are not considered as major surgery).
  13. Previously received FGFR4 inhibitor treatment.
  14. Blood transfusion, use of hematopoietic stimulating factors [including G-CSF (granulocyte colony stimulating factor), GM-CSF (granulocyte-macrophage colony stimulating factor), EPO (erythropoietin) and TPO (thrombopoietin)] and human albumin preparations within 14 days prior to first dose.
  15. Requiring corticosteroids (dose equivalent to > 10 mg/day of Prednisone) or other immunosuppressive drugs within 14 days prior to first dose for systemic therapy.
  16. Use of traditional Chinese medicine with anti-liver cancer indication within 14 days prior to the first dose.
  17. Subject has received potent CYP3A4 inhibitors and/or inducers within 2 weeks prior to first dose.
  18. Concurrent HBV and HCV infection.
  19. Subjects with known human immunodeficiency virus (HIV) infection.
  20. Lactating women.
  21. Subjects with a history of hypersensitivity or hypersensitivity to any of the components of the investigational drug.
  22. Circumstances that in the opinion of the investigator would preclude participation in the study.
  23. Subjects who are unwilling or unable to follow the study procedures as defined.

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): NCT04194801


Contacts
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Contact: Wendie YUAN +86 21 61097678 cstonera@cstonepharma.com

Locations
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China, Guangdong
Nanfang Hospital, Recruiting
Guangzhou, Guangdong, China
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150081
China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 201203
Sponsors and Collaborators
CStone Pharmaceuticals

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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04194801    
Other Study ID Numbers: CS3008-101
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases