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Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT04798781
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : September 21, 2021
Sponsor:
Collaborator:
EOC Pharma
Information provided by (Responsible Party):
Andrew Hendifar, MD, Cedars-Sinai Medical Center

Brief Summary:
This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.

Condition or disease Intervention/treatment Phase
Gastric Cancer Hepatocellular Carcinoma Drug: Telatinib Drug: Keytruda Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Safety and Efficacy of Telatinib in Combination With Keytruda in Subjects With Advanced Stomach and Gastroesophageal Junction Cancers or Hepatocellular Carcinoma
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: telatinib + Keytruda Drug: Telatinib
900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent

Drug: Keytruda
200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
Other Name: pembrolizumab




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: from the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years ]
    Duration of time from start of treatment until progression or death, whichever comes first


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: from the start of treatment until the end of treatment, approximately 12 months ]
    The percentage of patients who have a partial or complete response to treatment

  2. Disease control rate [ Time Frame: from the start of treatment until the end of treatment, approximately 12 months ]
    The percentage of patients who have stable disease, partial response, or complete response to treatment

  3. Overall survival [ Time Frame: from the start of treatment until the end of follow-up, approximately 18 months ]
    The length of time from the start of treatment that patients are still alive

  4. Incidence and severity of adverse events [ Time Frame: from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months ]
    Incidence and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5



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:

  • Diagnosis: Histologically confirmed gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy, indicated for Keytruda therapy. OR: Histologically confirmed hepatocellular carcinoma, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy.
  • At least 1 measurable metastatic lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and be documented by radiological evaluation within 28 days prior to registration. For subjects with locally advanced disease: at least one measurable lesion that has not been irradiated, documented by radiological evaluation within 28 days prior to registration.
  • Any prior radiation therapy must be completed at least 28 days prior to the first dose of study treatment.
  • Eighteen years of age or older.
  • Adequate bone marrow, liver, and renal function
  • Negative urine or serum pregnancy test for women of childbearing potential.
  • Women and men of childbearing potential must agree to use adequate contraception prior to registration, for the duration of study participation and until 4 months after the last study drug dosing.
  • Able to swallow tablets.

Exclusion Criteria:

  • Clinical or radiographic evidence of current brain metastasis. History of treated brain metastases is allowable.
  • Cardiac disease
  • Uncontrolled hypertension
  • Severe hemorrhage/bleeding event within 28 days prior to the first dose of study treatment
  • Major surgery, open biopsy, or significant traumatic injury within 42 days prior to the first dose of study treatment
  • Current serious, nonhealing wound, ulcer, or bone fracture within 42 days prior to the first dose of study treatment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment.
  • Presence of an uncontrolled infection or infection that required intravenous antibiotics, antifungals, or antivirals within 14 days prior to the first dose of study treatment.
  • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. The safety of telatinib in this subject population has not been studied.
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment or has been diagnosed with an autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine [T4], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.
  • History of (non-infectious) pneumonitis that required steroids, or current pneumonitis, or has a history of interstitial lung disease.
  • Has received a live-virus vaccination within 30 days of planned treatment start.
  • Known history of proteinuria > 1gr/24 hours.
  • Previous or concurrent cancer that is distinct in primary site or histology from the current stomach or liver cancer. Subjects with cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated are not excluded.
  • Anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent within 28 days prior to the first dose of study treatment.
  • Known or suspected allergy to any component of telatinib or Keytruda
  • Prior or current history of substance abuse, or medical, psychological, or social condition that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study result.
  • Women who are pregnant or breastfeeding.
  • Prior history of thromboembolic disease, e.g., deep vein thrombosis (DVT), pulmonary emboli (PE), within 6 months prior to the first dose of study treatment that has required continued medical intervention.
  • Baseline peripheral neuropathy.

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): NCT04798781


Contacts
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Contact: Amy Oppenheim 310-423-3713 Amy.Oppenheim@cshs.org

Locations
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United States, California
Tower Hematology Oncology Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact: Kortnee Calkins    310-285-7210    Kortnee.Calkins@cshs.org   
Sub-Investigator: David Hoffman, MD         
Sub-Investigator: Jeremy Lorber, MD         
Sub-Investigator: Kevin Scher, MD         
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: Jamie Perez       jperez@theangelesclinic.org   
Sub-Investigator: Vi Chiu, MD         
Sub-Investigator: Ani Balmanoukian, MD         
Sub-Investigator: Cathie Chung, MD         
Sub-Investigator: Rodolfo Gutierrez, MD         
Sub-Investigator: Omid Hamid, MD         
Sub-Investigator: Kristopher Wentzel, MD         
Sub-Investigator: Michelle Offner, NP         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Amy Oppenheim    310-423-3713    Amy.Oppenheim@cshs.org   
Principal Investigator: Andrew Hendifar, MD         
Sub-Investigator: Jun Gong, MD         
Sub-Investigator: Arsen Osipov, MD         
Sub-Investigator: Ju Dong Yang, MD         
Torrance Memorial Physician Network Cancer Care Physicians Recruiting
Torrance, California, United States, 90505
Contact: Courtney Steeneken, RN       Courtney.Steeneken@tmphysicians.com   
Sub-Investigator: Syed Jilani, MD         
Sub-Investigator: David Chan, MD         
Sub-Investigator: Vanessa Dickey, MD         
Sub-Investigator: Hugo Hool, MD         
Sub-Investigator: Andrew Horodner, MD         
Sub-Investigator: Thomas Lowe, MD         
Sub-Investigator: Swati Sikaria, MD         
Sponsors and Collaborators
Andrew Hendifar, MD
EOC Pharma
Investigators
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Principal Investigator: Andrew Hendifar, MD, MPH Cedars-Sinai Medical Center
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Responsible Party: Andrew Hendifar, MD, Assistant Professor, Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04798781    
Other Study ID Numbers: IIT2020-11-Hendifar-TELAT
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
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
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
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents