NCT03008512

Brief Summary

This study evaluate activity and safety profile of weekly Genexol-PM in patients with advanced hepatocellular carcinoma for whom sorafenib treatment failed. Patients will receive Genexol-PM on days 1, 8, and 15 every 4 weeks.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

4.3 years

First QC Date

December 29, 2016

Last Update Submit

February 2, 2021

Conditions

Carcinoma, Hepatocellular

Keywords

Liver NeoplasmsAntineoplastic AgentsCarcinoma, HepatocellularGenexol-PMNeoplasms by SiteSorafenibLiver DiseasesDigestive System Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival rate at 6 months

    Baseline to Objective Progression or Death from Any Cause (Approximately 12 Months)

Secondary Outcomes (4)

  • Progression-free survival

    Baseline to Objective Progression or Death from Any Cause (Approximately 12 Months)

  • Overall survival

    Baseline to Death from Any Cause (Approximately 12 Months)

  • Objective response rate

    Baseline to Objective Progression (Approximately 12 Months)

  • Adverse events

    Cycle 1 through Follow Up (Approximately 12 Months)

Study Arms (1)

Genexol-PM

EXPERIMENTAL

Genexol-PM 100 mg/m2 intravenously for 1 hour on days 1, 8, and 15 of a 28-day cycle up to 8 cycles. Patients will receive study treatment until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Genexol-PM

Interventions

Genexol-PMDRUG
Also known as: Cremophor-free, polymeric micelle-formulated paclitaxel
Genexol-PM

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of hepatocellular carcinoma (HCC) based on either
  • histopathologic or cytologic findings
  • a diagnosis of cirrhosis and HCC with classical imaging characteristics (at least a 3-phase liver protocol CT or MRI and a lesion that demonstrates arterial enhancement and washes out in the venous phase)
  • Radiologic confirmation of disease progression during or after discontinuation of sorafenib treatment or discontinuation of sorafenib due to intolerance despite appropriate supportive care
  • Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B disease not amenable to locoregional therapy or refractory to locoregional therapy
  • ≥ 1 measurable lesion according to RECIST Version 1.1
  • ≥ 20 year of age
  • ECOG performance status ≤ 2
  • Child-Pugh score ≤ 7
  • Informed consent prior to study
  • Adequate organ function
  • Hepatic: bilirubin ≤ 1.5 times upper limit of institutional normal value (ULN), AST or ALT ≤ 5 x ULN
  • Renal: estimated creatinine clearance ≥ 60 mL/min
  • Hematologic: hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500/μL, platelets ≥ 75,000/μL (In case of thrombocytopenia associated with hypersplenism in chronic liver disease, platelets ≥ 50,000/μL is allowed for participation at the physician's discretion.)
  • Coagulation: prothrombin time (INR) ≤ 1.5, partial thrombin time (PTT) ≤ 5 seconds above the ULN

You may not qualify if:

  • Previous systemic chemotherapy for advanced disease (except previous biologic agents including VEGF inhibitors, TGF-beta inhibitors, or PD-1/PD-L1 blockers)
  • A history o f or current hepatic encephalopathy or clinically meaningful ascites
  • Grade 2 or more peripheral neuropathy
  • Prior liver transplant
  • History of any other cancer within 2 years (Patients with carcinoma in situ of any origin and patients with prior malignancy who are in remission and whose likelihood of recurrence is very low, may be eligible.)
  • A history of treatment with taxanes (paclitaxel or docetaxel)
  • Females who are pregnant or lactating
  • A know allergy or hypersensitivity reaction to any of the treatment components
  • Serious preexisting medical conditions that cannot adequately controlled with appropriate therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gachon University Gil Medical Center

Incheon, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (4)

  • Kim TY, Kim DW, Chung JY, Shin SG, Kim SC, Heo DS, Kim NK, Bang YJ. Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies. Clin Cancer Res. 2004 Jun 1;10(11):3708-16. doi: 10.1158/1078-0432.CCR-03-0655.

    PMID: 15173077BACKGROUND

  • Strumberg D, Erhard J, Harstrick A, Klaassen U, Muller C, Eberhardt W, Wilke H, Seeber S. Phase I study of a weekly 1 h infusion of paclitaxel in patients with unresectable hepatocellular carcinoma. Eur J Cancer. 1998 Jul;34(8):1290-2. doi: 10.1016/s0959-8049(98)00054-9.

    PMID: 9849493BACKGROUND

  • Bocci G, Di Paolo A, Danesi R. The pharmacological bases of the antiangiogenic activity of paclitaxel. Angiogenesis. 2013 Jul;16(3):481-92. doi: 10.1007/s10456-013-9334-0. Epub 2013 Feb 7.

    PMID: 23389639BACKGROUND

  • Baird RD, Tan DS, Kaye SB. Weekly paclitaxel in the treatment of recurrent ovarian cancer. Nat Rev Clin Oncol. 2010 Oct;7(10):575-82. doi: 10.1038/nrclinonc.2010.120. Epub 2010 Aug 3.

    PMID: 20683437BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsNeoplasms by SiteLiver DiseasesDigestive System Neoplasms

Interventions

genexol-PM

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System Diseases

Study Officials

  • Dong Bok Shin, Professor

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 2, 2017

Study Start

October 1, 2016

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

KR(2)