NCT01098760: HATT

A Phase IV, Single-arm, Open-label Study of Sorafenib (Nexavar®) in Advanced Hepatocellular Carcinoma (HCC)

Completed Phase 4 Last updated 30 October 2013

What this trial tests

Phase 4 trial testing Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment in Hepatocellular Carcinoma in 151 participants. Completed in 1 October 2013.

Timeline

1 August 2010

Primary endpoint
1 March 2013

1 October 2013

Quick facts

Lead sponsor	Bayer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	151
Start date	1 August 2010
Primary completion	1 March 2013
Estimated completion	1 October 2013
Sites	7 locations across Taiwan

Drugs / interventions tested

• Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to progression
  Time frame: 30 months
• Progression-free survival
  Time frame: 30 months
• Overall survival
  Time frame: 30 months
• Adverse event and serious adverse event (SAE) profiles
  Time frame: 30 months
• Child-Pugh status progression
  Time frame: 30 months
• Plasma Sorafenib exposure (AUC0-12)
  Time frame: 30 months

Sponsor's own description

This is a single-arm, open-label and post-authorization study to evaluate the safety and efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with advanced HCC treated with sorafenib in Taiwan.

In a subgroup of patients (hand-foot skin reaction (HFSR) study subgroup), this study also aims to test if topical corticosteroids as preventive counter-measure applied to hands and feet for the first 3 weeks during sorafenib treatment reduce incidence and severity of HFSR compared to a matching, corticosteroid-free cosmetic ointment, measured over the first 3 and 6 weeks of sorafenib treatment.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor stroma as targets for cancer therapy.
   Zhang J, Liu J. · · 2013 · cited 139× · PMID 23064233 · DOI 10.1016/j.pharmthera.2012.10.003
2. SREBP Regulation of Lipid Metabolism in Liver Disease, and Therapeutic Strategies.
   Li N, Li X, Ding Y, Liu X, et al · · 2023 · cited 79× · PMID 38137501 · DOI 10.3390/biomedicines11123280
3. HATT: a phase IV, single-arm, open-label study of sorafenib in Taiwanese patients with advanced hepatocellular carcinoma.
   Lin SM, Lu SN, Chen PT, Jeng LB, et al · · 2017 · cited 13× · PMID 27909950 · DOI 10.1007/s12072-016-9774-x
4. Efficacy and safety of FLT3 inhibitors in monotherapy of hematological and solid malignancies: a systemic analysis of clinical trials.
   Zhao Y, Zhang X, Ding X, Wang Y, et al · · 2024 · cited 7× · PMID 38828446 · DOI 10.3389/fphar.2024.1294668
5. Small molecule tyrosine kinase inhibitors approved for systemic therapy of advanced hepatocellular carcinoma: recent advances and future perspectives.
   Liu J, Xia S, Zhang B, Mohammed DM, et al · · 2024 · cited 5× · PMID 38960980 · DOI 10.1007/s12672-024-01110-0