GNS561-CL-I-Q-0211: Phase 1/2 Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients with Primary Liver Cancer which includes Intrahepatic cholangiocarcinoma patients

Study Name
GNS561-CL-I-Q-0211: Phase 1/2 Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients with Primary Liver Cancer which includes Intrahepatic cholangiocarcinoma patients
ClinicalTrials.gov Identifier (if applicable)
NCT03316222
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Chemotherapy
  • Other Novel Therapy
Study Center
Institution Name
Memorial Sloan Kettering
Institution Address
300 E 53rd St
City
New York
State
New York
Zip Code
10065
Study Contacts
Principal Investigator
Pr James Harding
P.I. Phone
(646) 888-4314
P.I. Email
hardinj1@mskcc.org
List additional Principal Investigators (include phone number and email)
Pr Ghassan Abou-Alfa, (646) 888-4184, abou-alg@mskcc.org
Study Coordinator
Amanda Simms
Study Coordinator Phone
(646) 888-4314
Study Coordinator Email
simmsa@mskcc.org
List additional Study Coordinators (include phone number and email)
Brittanie Millans, millangb@mskcc.org
OVERVIEW – in layman’s terms (150 words max)
This is a multicenter, open-label, uncontrolled, repeat-dose phase 1/2a study designed to evaluate the safety profile and to determine the Recommended Dose of GNS561 in patients with advanced primary liver cancer (Hepatocarcinoma, Intrahepatic Cholangiocarcinoma). This study consists of 2 parts: escalation and expansion phase.
Enrollment
50 patients, recruiting
Study Start Date
04/04/2018
Estimated Completion Date
01/15/2020
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • • To characterize the safety and tolerability of GNS561 + To identify the recommended Phase 2 dose + To identify evidence of antitumor activity
Inclusion Criteria – Patients Must:
  • 1.Males or females ≥ 18 years of age. 2.Histologically confirmed and documented locally advanced or metastatic HCC that is deemed not appropriate for curative therapy or histologically confirmed and documented locally advanced or metastatic intrahepatic cholangiocarcinoma. 3. Previously exposed, intolerant or refractory to at least one prior dose of sorafenib and for which no curative therapy is available for HCC patients or Previously exposed, intolerant or refractory to at least one first line chemotherapy and for which no curative therapy is available for intrahepatic patients.
Exclusion Criteria – Patients Must NOT:
  • Pregnant or breast-feeding mothers
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • this is a first-in-human trial
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