Kaposi's SarcomaPhase 1NCT00287495
BAY 43-9006 (Sorafenib) to Treat Patients With Kaposi's Sarcoma
A Phase 1 study testing BAY 43-9006 in people with Kaposi's Sarcoma and HHV-8, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Kaposi's Sarcoma, HHV-8, KSHV
- What is being tested?
- BAY 43-9006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2006to 18 Oct 2017
- Phase
- Phase 1
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater.
- Kaposi's sarcoma (KS) pathologically confirmed by CCR Pathology. Patients with both HIV-associated and HIV-negative KS will be eligible.
- Either (1) at least 5 measurable cutaneous KS lesions with no previous local therapy, or (2) other measurable non-cutaneous disease that permits a response to be assessed.
- Patients with HIV-related KS must be receiving and be willing to comply with a regimen of highly active antiretroviral therapy (HAART) consistent with DHHS treatment guidelines that either (1) utilizes 3 or more drugs or (2) attains suppression of HIV below the limit of detection (50 copies HIV/ml using Roche Amplicor Monitor assay or similar standard test).
- For patients with HIV-associated KS, KS lesions must either (1) be increasing during the 3 months prior to screening while the patient is receiving HAART or has unchanged suppression of HIV to below the limits of detection; or (2) must be stable for at least four months while the patient is taking highly active antiretroviral therapy (HAART).
- ECOG performance status less than or equal to 2
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- Life expectancy greater than 6 months
- The following hematologic parameters:
- Hemoglobin greater than 9 g/l
- WBC greater than 1000/mm(3)
- Platelets greater than 75,000/mm(3)
- PT and PTT less than or equal to 120% of control, unless the patient has the presence of a lupus anticoagulant
- The following hepatic parameters:
- For patients not receiving protease inhibitor therapy: bilirubin less than or equal to 1.5 times the upper limit of normal (ULN). For patients receiving protease inhibitor therapy and for whom the elevated bilirubin is felt to be related to this therapy total bilirubin should be less than or equal to 3.7 mg/dl with a direct fraction less than or equal to 0.2 mg/dl.
- AST/GOT less than or equal to 2.5 times the ULN
- Either serum creatinine less than or equal to 1.5 mg/dl or measured creatinine clearance greater than 60 mL/min.
- Patients must be willing to use effective birth control.
Who cannot join
- Patients with extensive active or symptomatic pulmonary KS
- Patients with symptomatic visceral KS, except for that involving the oral cavity
- KS that appears to be improving after other therapy
- Inability to provide informed consent
- Patients requiring systemic therapy with ketoconazole or itraconazole
- Cytotoxic chemotherapy or other specific KS therapy (except for antiretroviral therapy) within the past 3 weeks.
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- Prior therapy with BAY 43-9006
- Known hypersensitivity to BAY 43-9006
- Supraphysiologic doses of corticosteroids within 3 weeks
- Pregnancy (because of unknown potential for fetal malformation)
- Breast feeding (because of unknown potential for adverse infant developmental considerations)
- Past or present history of malignant tumors other than KS unless: a) in complete remission for greater than or equal to 1 year from the time a response was first documented; b) completely resected basal cell carcinoma; or c) in situ squamous cell carcinoma of the cervix or anus
- Evidence of severe or life-threatening infection within 2 weeks of entry into the study
- Elevated lipase greater than 2 times the ULN or amylase greater than 2 times the ULN (unless documented to be of non-pancreatic origin or associated with macroamylasemia
- Patients with any other abnormality that would be scored as a grade 3 or greater toxicity, except:
- lymphopenia
- direct manifestation of KS
- direct manifestation of HIV infection, except for neurologic or cardiac manifestations.
- direct manifestation of HIV therapy, except for neurologic or cardiac manifestations or those addressed elsewhere in the eligibility requirements or that would be scored as grade 4.
- asymptomatic hyperuricemia
- Any condition that, in the opinion of the principal Investigator or Study Chairperson would preclude the inclusion of a patient into this research study.
- Patients must not have evidence of a bleeding diathesis.
- Patients must not be on therapeutic coagulation. Prophylactic anticoagulation (i.e. low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for PT and PTT are met.
- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, and Phenobarbital), rifampin, or St. Johns Wort.
- Patients are excluded if they have uncontrolled hypertension (diastolic blood pressure greater than 99 mm Hg or systolic blood pressure greater than 159 mm Hg)
- Patients are excluded if they have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must be able to understand and be willing to sign a written informed consent document, and express willingness and the ability to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Phase I and Pharmacokinetic Study of BAY 43-9006 (Sorafenib) in Patients With Kaposi's Sarcoma
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.
Read more
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.
Read the detailed description
BACKGROUND: This study is designed to test the toxicity and pharmacokinetics of different doses of BAY 43-9006 (Sorafenib) in patients with Kaposi s sarcoma (KS). It will also assess, in a preliminary manner, the activity of BAY 43-9006 in this disease and its effect on biological markers. BAY 43-9006 is a potent inhibitor of wild-type and mutant c-Raf kinase isoforms. In addition, this agent also inhibits p38, c-kit, vascular endothelial growth factor receptor 2(VEGFR2), VEGF-R3, and platelet derived growth factor receptor beta (PDGFR-B). There is evidence that several of these receptors, and especially VEGF-R2, VEGF-R3, and PDGF-RB, are important in KS pathogenesis. The principle tumor cells of KS lesions are spindle cells, which are derived from endothelial cells. Spindle cells proliferate in response to VEGF, VEGF-C (a ligand for VEGF-R3), and PDGF, and the stimulation of spindle cells by these factors appears to be an important component in the pathogenesis of KS. There is also evidence that c-kit is important in KS. Because BAY 43-9006 can inhibit the function of these receptors and c-kit, it may have specific activity against this tumor. BAY 43-9006 is metabolized at least in part by CYP 3A4, and ritonavir, an HIV protease inhibitor commonly used in AIDS patients, is an inhibitor of CYP 3A4. Also, AIDS patients are often quite sensitive to drug toxicities. Thus, patients with AIDS-KS on ritonavir may be particularly sensitive to BAY 43-9006.
OBJECTIVES: To assess the toxicity profile and pharmacokinetics of BAY 43-9006 at oral dose regimens of 200 mg once daily, 200mg twice daily, or 400 mg twice daily, up to the toxic dose, in patients with HIV-associated Kaposi s sarcoma (KS) who are receiving ritonavir. Also, to assess in a preliminary manner the pharmacokinetics and toxicity profile of BAY 43-9006 in patients who are not receiving ritonavir.
ELIGIBILITY: Key eligibility criteria are as follows: patients 18 years of age or older, with or without HIV infection, and with KS and at least 5 cutaneous lesions untreated by local therapy; patients with HIV infection must have KS that is progressing or stable on highly active antiretroviral therapy (HAART); patients with extensive active, visceral, or symptomatic KS are excluded.
DESIGN: Patients with AIDS-KS who are receiving ritonavir will be administered BAY 43-9006. An initial group of patients will be administered 200 mg BAY 43-9006 once daily, and subsequent groups will receive 200 mg twice daily and 400 mg twice daily respectively. Also two groups of patients with KS and not on ritonavir will be administered 200 mg and 400 mg BAY 43-9006 twice daily respectively. Patients will be studied for toxicity, pharmacokinetics, KS response, the effect on biological markers such as target receptor kinase phosphorylation and signaling molecules in KS tissue. Other parameters that will be assessed will include VEGF levels, the viral load of KSHV, and KS lesion blood flow by non-invasive techniques. If patients tolerate BAY 43-9006, they will receive it for up to 24 weeks. If they have evidence of stable KS or a tumor response, they may receive the drug for up to 54 weeks total.
- Conditions
- Kaposi's Sarcoma, HHV-8, KSHV
- Being tested
- BAY 43-9006
- Keywords
- AIDS, HIV, Antiangiogenesis, VEGF, AIDS Malignancy, Kaposi Sarcoma, KS
- Medical subject headings
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 43-9006Drug
BAY 43-9006 200 mg once daily with dose escalation up to 400 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients with AIDS-KS receiving ritonavir will be given 200 mg BAY 43-9006 once daily with dose escalation up to 400 mg twice daily Receives: Drug: BAY 43-9006 |
| B | Experimental | Patients with AIDS-KS not receiving ritonavir will be given 200 mg BAY 43-9006 once daily with dose escalation up to 400 mg twice daily Receives: Drug: BAY 43-9006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess toxicity profile and pharmacokinetics of BAY 43-9006
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study start2 Feb 2006
- Primary completion21 Sep 2012
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kaposi's SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert Yarchoan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287495
- Sponsor's protocol ID
- 060083
- Other IDs
- 06-C-0083
- Status last verified
- 18 Oct 2017
- First submitted
- 4 Feb 2006
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Gao SJ, Kingsley L, Li M, Zheng W, Parravicini C, Ziegler J, Newton R, Rinaldo CR, Saah A, Phair J, Detels R, Chang Y, Moore PS. KSHV antibodies among Americans, Italians and Ugandans with and without Kaposi's sarcoma. Nat Med. 1996 Aug;2(8):925-8. doi: 10.1038/nm0896-925.
PubMed 8705864Biggar RJ, Rosenberg PS, Cote T. Kaposi's sarcoma and non-Hodgkin's lymphoma following the diagnosis of AIDS. Multistate AIDS/Cancer Match Study Group. Int J Cancer. 1996 Dec 11;68(6):754-8. doi: 10.1002/(SICI)1097-0215(19961211)68:63.0.CO;2-0.
PubMed 8980179Antman K, Chang Y. Kaposi's sarcoma. N Engl J Med. 2000 Apr 6;342(14):1027-38. doi: 10.1056/NEJM200004063421407. No abstract available.
PubMed 10749966Uldrick TS, Goncalves PH, Wyvill KM, Peer CJ, Bernstein W, Aleman K, Polizzotto MN, Venzon D, Steinberg SM, Marshall V, Whitby D, Little RF, Wright JJ, Rudek MA, Figg WD, Yarchoan R. A Phase Ib Study of Sorafenib (BAY 43-9006) in Patients with Kaposi Sarcoma. Oncologist. 2017 May;22(5):505-e49. doi: 10.1634/theoncologist.2016-0486. Epub 2017 Mar 24.
PubMed 28341759
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I and Pharmacokinetic Study of BAY 43-9006 (Sorafenib) in Patients With Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00287495
- Acronym / sponsor ID
- 060083
- Conditions
- Kaposi's Sarcoma, HHV-8, KSHV
- Keywords
- AIDS, HIV, Antiangiogenesis, VEGF, AIDS Malignancy, Kaposi Sarcoma, KS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Feb 2006
- Primary completion
- 21 Sep 2012 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND: This study is designed to test the toxicity and pharmacokinetics of different doses of BAY 43-9006 (Sorafenib) in patients with Kaposi s sarcoma (KS). It will also assess, in a preliminary manner, the activity of BAY 43-9006 in this disease and its effect on biological markers. BAY 43-9006 is a potent inhibitor of wild-type and mutant c-Raf kinase isoforms. In addition, this agent also inhibits p38, c-kit, vascular endothelial growth factor receptor 2(VEGFR2), VEGF-R3, and platelet derived growth factor receptor beta (PDGFR-B). There is evidence that several of these receptors, and especially VEGF-R2, VEGF-R3, and PDGF-RB, are important in KS pathogenesis. The principle tumor cells of KS lesions are spindle cells, which are derived from endothelial cells. Spindle cells proliferate in response to VEGF, VEGF-C (a ligand for VEGF-R3), and PDGF, and the stimulation of spindle cells by these factors appears to be an important component in the pathogenesis of KS. There is also evidence that c-kit is important in KS. Because BAY 43-9006 can inhibit the function of these receptors and c-kit, it may have specific activity against this tumor. BAY 43-9006 is metabolized at least in part by CYP 3A4, and ritonavir, an HIV protease inhibitor commonly used in AIDS patients, is an inhibitor of CYP 3A4. Also, AIDS patients are often quite sensitive to drug toxicities. Thus, patients with AIDS-KS on ritonavir may be particularly sensitive to BAY 43-9006.
OBJECTIVES: To assess the toxicity profile and pharmacokinetics of BAY 43-9006 at oral dose regimens of 200 mg once daily, 200mg twice daily, or 400 mg twice daily, up to the toxic dose, in patients with HIV-associated Kaposi s sarcoma (KS) who are receiving ritonavir. Also, to assess in a preliminary manner the pharmacokinetics and toxicity profile of BAY 43-9006 in patients who are not receiving ritonavir.
ELIGIBILITY: Key eligibility criteria are as follows: patients 18 years of age or older, with or without HIV infection, and with KS and at least 5 cutaneous lesions untreated by local therapy; patients with HIV infection must have KS that is progressing or stable on highly active antiretroviral therapy (HAART); patients with extensive active, visceral, or symptomatic KS are excluded.
DESIGN: Patients with AIDS-KS who are receiving ritonavir will be administered BAY 43-9006. An initial group of patients will be administered 200 mg BAY 43-9006 once daily, and subsequent groups will receive 200 mg twice daily and 400 mg twice daily respectively. Also two groups of patients with KS and not on ritonavir will be administered 200 mg and 400 mg BAY 43-9006 twice daily respectively. Patients will be studied for toxicity, pharmacokinetics, KS response, the effect on biological markers such as target receptor kinase phosphorylation and signaling molecules in KS tissue. Other parameters that will be assessed will include VEGF levels, the viral load of KSHV, and KS lesion blood flow by non-invasive techniques. If patients tolerate BAY 43-9006, they will receive it for up to 24 weeks. If they have evidence of stable KS or a tumor response, they may receive the drug for up to 54 weeks total.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: BAY 43-9006Patients with AIDS-KS receiving ritonavir will be given 200 mg BAY 43-9006 once daily with dose escalation up to 400 mg twice daily |
| B | Experimental | Drug: BAY 43-9006Patients with AIDS-KS not receiving ritonavir will be given 200 mg BAY 43-9006 once daily with dose escalation up to 400 mg twice daily |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Hemoglobin greater than 9 g/l
- WBC greater than 1000/mm(3)
- Platelets greater than 75,000/mm(3)
- PT and PTT less than or equal to 120% of control, unless the patient has the presence of a lupus anticoagulant
- For patients not receiving protease inhibitor therapy: bilirubin less than or equal to 1.5 times the upper limit of normal (ULN). For patients receiving protease inhibitor therapy and for whom the elevated bilirubin is felt to be related to this therapy total bilirubin should be less than or equal to 3.7 mg/dl with a direct fraction less than or equal to 0.2 mg/dl.
Key exclusion criteria (27 listed)
- Patients with extensive active or symptomatic pulmonary KS
- Patients with symptomatic visceral KS, except for that involving the oral cavity
- KS that appears to be improving after other therapy
- Inability to provide informed consent
- Patients requiring systemic therapy with ketoconazole or itraconazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY 43-9006BAY 43-9006 200 mg once daily with dose escalation up to 400 mg twice daily | Drug | A, B |
Primary outcome
Assess toxicity profile and pharmacokinetics of BAY 43-9006
Time frame: 3 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 8705864Gao SJ, Kingsley L, Li M, Zheng W, Parravicini C, Ziegler J, Newton R, Rinaldo CR, Saah A, Phair J, Detels R, Chang Y, Moore PS. KSHV antibodies among Americans, Italians and Ugandans with and without Kaposi's sarcoma. Nat Med. 1996 Aug;2(8):925-8. doi: 10.1038/nm0896-925.
- Background: PubMed 8980179Biggar RJ, Rosenberg PS, Cote T. Kaposi's sarcoma and non-Hodgkin's lymphoma following the diagnosis of AIDS. Multistate AIDS/Cancer Match Study Group. Int J Cancer. 1996 Dec 11;68(6):754-8. doi: 10.1002/(SICI)1097-0215(19961211)68:63.0.CO;2-0.
- Background: PubMed 10749966Antman K, Chang Y. Kaposi's sarcoma. N Engl J Med. 2000 Apr 6;342(14):1027-38. doi: 10.1056/NEJM200004063421407. No abstract available.
- Derived from this study: PubMed 28341759Uldrick TS, Goncalves PH, Wyvill KM, Peer CJ, Bernstein W, Aleman K, Polizzotto MN, Venzon D, Steinberg SM, Marshall V, Whitby D, Little RF, Wright JJ, Rudek MA, Figg WD, Yarchoan R. A Phase Ib Study of Sorafenib (BAY 43-9006) in Patients with Kaposi Sarcoma. Oncologist. 2017 May;22(5):505-e49. doi: 10.1634/theoncologist.2016-0486. Epub 2017 Mar 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Yarchoan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY 43-9006 in people with Kaposi's Sarcoma and HHV-8, run by National Cancer Institute (NCI) at 1 site in United States.
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 17 inclusion and 27 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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. 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?
Assess toxicity profile and pharmacokinetics of BAY 43-9006 (time frame: 3 weeks). 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 NCT00287495, 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 12 Dec 2019.