NCT00101036

A Phase II Study of GW572016 (Lapatanib) in Locally Advanced or Metastatic Hepato-Biliary Cancers

Completed Phase 2 Results posted Last updated 22 March 2018

What this trial tests

Phase 2 trial testing lapatinib ditosylate in Adult Primary Hepatocellular Carcinoma in 57 participants. Completed in 1 January 2009.

Timeline

1 November 2004

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	1 November 2004
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	1 location across United States

Drugs / interventions tested

• lapatinib ditosylate — full drug profile →
• laboratory biomarker analysis — full drug profile →

Conditions studied

• Adult Primary Hepatocellular Carcinoma — all drugs for Adult Primary Hepatocellular Carcinoma →
• Advanced Adult Primary Liver Cancer — all drugs for Advanced Adult Primary Liver Cancer →
• Localized Unresectable Adult Primary Liver Cancer — all drugs for Localized Unresectable Adult Primary Liver Cancer →
• Recurrent Adult Primary Liver Cancer — all drugs for Recurrent Adult Primary Liver Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Adult Primary Hepatocellular Carcinoma or Advanced Adult Primary Liver Cancer. 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.

• Response Rate
  Time frame: Up to 5 years
  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Sponsor's own description

This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

1. Targeted therapy for hepatocellular carcinoma: novel agents on the horizon.
   Cervello M, McCubrey JA, Cusimano A, Lampiasi N, et al · · 2012 · cited 139× · PMID 22470194 · DOI 10.18632/oncotarget.466
2. Overview of current targeted therapy in gallbladder cancer.
   Song X, Hu Y, Li Y, Shao R, et al · · 2020 · cited 123× · PMID 33028805 · DOI 10.1038/s41392-020-00324-2
3. The Role of Autophagy in Liver Cancer: Crosstalk in Signaling Pathways and Potential Therapeutic Targets.
   Cui J, Shen HM, Lim LHK. · · 2020 · cited 45× · PMID 33260729 · DOI 10.3390/ph13120432
4. Promising Molecular Targets for the Targeted Therapy of Biliary Tract Cancers: An Overview.
   Yang W, Sun Y. · · 2021 · cited 17× · PMID 33658799 · DOI 10.2147/ott.s297643
5. Targeted therapies in the treatment of advanced hepatocellular carcinoma.
   Wei Z, Doria C, Liu Y. · · 2013 · cited 16× · PMID 23761989 · DOI 10.4137/cmo.s7633
6. The Role of HER2 Status in the Biliary Tract Cancers.
   Ayasun R, Ozer M, Sahin I. · · 2023 · cited 11× · PMID 37174094 · DOI 10.3390/cancers15092628
7. Targeted therapies for extrahepatic cholangiocarcinoma: preclinical and clinical development and prospects for the clinic.
   Cadamuro M, Lasagni A, Lamarca A, Fouassier L, et al · · 2021 · cited 6× · PMID 33622120 · DOI 10.1080/13543784.2021.1880564
8. Research on Targeted Therapy for Malignant Tumors of the Biliary Tract.
   Yang Y, Zhong H, Zhang J, Wang P. · · 2026 · PMID 42146765 · DOI 10.2147/ott.s593457