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Carcinoma, HepatocellularPhase 2NCT03008512

A Phase II Study of Weekly Genexol-PM in Patients With Hepatocelluar Carcinoma After Failure of Sorafenib

A Phase 2 study testing Genexol-PM in people with Carcinoma, Hepatocellular, run by Gachon University Gil Medical Center at 2 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Genexol-PM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesSouth Korea
Study dates
Oct 2016to Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Previous sorafenib treatment for at least 14 days and discontinuation of sorafenib treatment prior to inclusion
  • 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
Show all 16Show fewer
  • ≥ 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Gachon University Gil Medical Center

    Incheon

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: A Phase II Study of Weekly Genexol-PM in Patients With Advanced Hepatocelluar Carcinoma After Failure of Sorafenib

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.

Read the detailed description

Hepatocelluar carcinoma (HCC) is a highly vascular neoplasm characterized by arterial enhancement on CT or MRI. Angiogenesis provides a target for novel prognostic and therapeutic approaches to HCC. Sorafenib is the standard 1st-line therapy shown to significantly improve overall survival in advanced HCC. However, sorafenib benefits are mostly transient and modest. In addition, sorafenib is associated with major toxicities, and about 30% of patients stop it because of intolerance. Effective therapies are needed for patients who experience progression during or after receiving sorafenib or who have sorafenib intolerance. Paclitaxel has an antiagiogenic activity and weekly administration of paclitaxel is considered to have enhanced efficacy over 3-weekly administration due to greater drug exposure or a direct antiangiogenic effect. A previous phase I study showed that weekly paclitaxel has activity in hepatocellular carcinoma and further investigation in phase II trials is warranted. Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, is believed to be superior to conventional paclitaxel in terms of the obviation of premedication and the delivery of higher paclitaxel doses without additional toxicity.

Being tested
Genexol-PM
Keywords
Liver Neoplasms, Antineoplastic Agents, Carcinoma, Hepatocellular, Genexol-PM, Neoplasms by Site, Sorafenib, Liver Diseases, Digestive System Neoplasms
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasms by Site, Liver Diseases, Digestive System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genexol-PMDrug

    Also called Cremophor-free, polymeric micelle-formulated paclitaxel

Study groups in NCT03008512
Study groupRoleWhat they receive
Genexol-PMExperimentalGenexol-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.
Receives: Drug: Genexol-PM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival rate at 6 months

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

Secondary outcomes (4)

  1. Progression-free survival

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

  2. Overall survival

    Measured: Baseline to Death from Any Cause (Approximately 12 Months)

  3. Objective response rate

    Measured: Baseline to Objective Progression (Approximately 12 Months)

  4. Adverse events

    NCI-CTCAE V4.03

    Measured: Cycle 1 through Follow Up (Approximately 12 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionFeb 2021
  4. Study completionFeb 2021

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008512
Sponsor's protocol ID
weGePM-HCC
Status last verified
Feb 2021
First submitted
29 Dec 2016
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15173077

  • 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.

    PubMed 9849493

  • 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.

    PubMed 23389639

  • 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.

    PubMed 20683437

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Genexol-PM in people with Carcinoma, Hepatocellular, run by Gachon University Gil Medical Center at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Poor accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate at 6 months (time frame: Baseline to Objective Progression or Death from Any Cause (Approximately 12 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008512, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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