| 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
|
