A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
Sponsor: Bayer
Listed as NCT00108953, this PHASE2 trial focuses on Carcinoma, Hepatocellular and remains completed. Sponsored by Bayer, it has been updated 8 times since 2005, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.
The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.
The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).
In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.
The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.
The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Apr 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bayer
For direct contact, visit the study record on ClinicalTrials.gov .