NCT00287495

BAY 43-9006 (Sorafenib) to Treat Patients With Kaposi's Sarcoma

Terminated Phase 1 Last updated 12 December 2019

What this trial tests

Phase 1 trial testing BAY 43-9006 in Kaposi's Sarcoma in 10 participants. Terminated before completion.

Timeline

2 February 2006

Primary endpoint
21 September 2012

18 October 2017

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	2 February 2006
Primary completion	21 September 2012
Estimated completion	18 October 2017
Sites	1 location across United States

Drugs / interventions tested

• BAY 43-9006 — full drug profile →

Conditions studied

• Kaposi's Sarcoma — all drugs for Kaposi's Sarcoma →
• HHV-8 — all drugs for HHV-8 →
• KSHV — all drugs for KSHV →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 110, any sex, with Kaposi's Sarcoma or HHV-8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Kaposi's sarcoma (KS) is a disease in which cancer cells are found in the tissues under the skin or mucous membranes that line the mouth, nose, and anus. KS causes red or purple patches (lesions) on the skin or mucous membranes and spreads to other organs in the body, such as the lungs, liver, or intestinal tract.
* BAY 43-9006 inhibits the activity of several proteins or protein receptors in cells that are thought to be important to the progression of KS. Blocking these mechanisms may cause KS to get better.

Objectives:

* To learn about the toxicity and blood levels of BAY 43-9006 in people with KS who are and are not taking the anti-retroviral drug ritonavir.
* To look for evidence of a beneficial treatment effect of BAY 43-9006

Eligibility:

* Adults with confirmed KS, both HIV-positive and HIV-negative.
* Patients must have either 1) at least five measurable KS lesions with no previous local therapy, or 2) other measurable non-skin disease that permits evaluation of a response to treatment.

Design:

* Patients are randomly assigned to a specific dose of BAY 43-9006. They take the drug by mouth either once or twice daily, depending on their dose group, for up to 54 weeks.
* Drug blood levels are determined after patients have been taking BAY 43-9006 for 1 to 2 weeks by blood collections immediately before the dose and at 1, 2, 4, 8, 12, 16 and 24 hours after the dose.
* Patients are evaluated every 3 weeks with review of a medication diary, interview about drug side effects, physical examination, and assessment of KS lesions.
* KS lesions are photographed on entering the study and at other time points during the study.
* CD4 cell counts and HIV viral load are tested every 12 weeks.
* Biopsies are done at the start of the study, on day 15, and if it appears that all of the lesions have resolved.
* Other procedures, such as CT or MRI scans, may be done if medically indicated.

Publications & conference data

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

1. Kaposi sarcoma-associated herpesvirus-associated malignancies: epidemiology, pathogenesis, and advances in treatment.
   Bhutani M, Polizzotto MN, Uldrick TS, Yarchoan R. · · 2015 · cited 108× · PMID 25843728 · DOI 10.1053/j.seminoncol.2014.12.027
2. BRAF mutation and its inhibitors in sarcoma treatment.
   Liu H, Nazmun N, Hassan S, Liu X, et al · · 2020 · cited 40× · PMID 32476297 · DOI 10.1002/cam4.3103
3. A Phase Ib Study of Sorafenib (BAY 43-9006) in Patients with Kaposi Sarcoma.
   Uldrick TS, Gonçalves PH, Wyvill KM, Peer CJ, et al · · 2017 · cited 20× · PMID 28341759 · DOI 10.1634/theoncologist.2016-0486
4. Potential of protein kinase inhibitors for treating herpesvirus-associated disease.
   Li R, Hayward SD. · · 2013 · cited 18× · PMID 23608036 · DOI 10.1016/j.tim.2013.03.005
5. Targeting Kaposi's Sarcoma-Associated Herpesvirus ORF21 Tyrosine Kinase and Viral Lytic Reactivation by Tyrosine Kinase Inhibitors Approved for Clinical Use.
   Beauclair G, Naimo E, Dubich T, Rückert J, et al · · 2020 · cited 15× · PMID 31826996 · DOI 10.1128/jvi.01791-19