Unspecified Adult Solid TumorPhase 1NCT01450384
Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing sorafenib tosylate, pemetrexed disodium and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor
- What is being tested?
- sorafenib tosylate, pemetrexed disodium and laboratory biomarker analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced solid tumor malignancy for which there is no potentially curative treatment; there is no limit to the number of prior lines of therapy
- Performance status Eastern Cooperative Oncology Group (ECOG) equal or less than 1
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper institutional limit (ULN)
- Total bilirubin =< 1.5 ULN
- Creatinine clearance (CrCl) >= 45 mL/min as measured by the standard Cockcroft-Gault equation
- International normalized ratio (INR) =< 1.5 (if not due to anticoagulants)
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- White blood cell count (WBC) >= 3,000 cells/mm3
- Absolute neutrophil count (ANC) >= 1,500 cells/mm3
- Platelets >= 100,000 cells/mm3
- Hemoglobin (Hgb) >= 8.5 g/dL
- Prior toxicities are allowed as long as they are stable and would not interfere with study drug toxicity assessment
- Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) (v 1.1)
- Ability to understand and the willingness to sign a written informed consent document; a signed informed consent must be obtained prior to any study specific procedures
- Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment; women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation; men must agree to use a medically accepted form of birth control for 2 months following completion of study treatment
Who cannot join
- Any investigational agent within 4 weeks of first dose of study treatment
- Unwillingness or inability to take folic acid, vitamin B12, or dexamethasone
- Known or presumed intolerance of pemetrexed or sorafenib; unable to swallow medication; suspected malabsorption
- Active illicit substance or alcohol abuse
- Contraindication to antiangiogenic agents, including:
- Pulmonary hemorrhage/bleeding event >= Grade 2 within 4 weeks or less prior to the first dose of study drug
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- Any other hemorrhage/bleeding event >= Grade 3 within 4 weeks or less prior to the first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Thrombolic or embolic events such as a myocardial infarction, cerebrovascular accident including transient ischemic attacks within the past 6 months
- Major cardiac dysfunction, such as uncontrolled angina, congestive heart failure with New York Heart Association (NYHA) class III or higher, ventricular arrhythmias requiring anti-arrhythmic therapy
- Systolic blood pressure > 160 mmHg or diastolic pressure > 100 mmHg despite optimal medical management
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5 day period
- Serious uncontrolled infection > Common Terminology Criteria for Adverse Events (CTCAE) (v 4) grade 2
- Peripheral motor or sensory neuropathy>CTCAE (v4) grade 2
- Uncontrolled metastatic brain disease
- Serum B12 or folate levels below the institution's lower limit of normal. Patients may begin B12/folic acid supplementation and can be reconsidered for study once levels meet the eligibility requirements
- Administration of non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to pemetrexed dosing (note: if a candidate routinely takes NSAIDs prior to enrollment, consider transition to alternate non-NSAID for duration of study treatment, if possible).
- Other condition(s) that in the opinion of the investigator might compromise the objectives of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Phase I Study of Pemetrexed and Sorafenib in Advanced Malignancy
This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib tosylate may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine doses for the combination of pemetrexed (pemetrexed disodium) with sorafenib (sorafenib tosylate) appropriate for Phase II study.
SECONDARY OBJECTIVES:
- To evaluate the safety, tolerance, and toxicity of the combination of pemetrexed and sorafenib.
II. To observe antitumor effects of the combination.
OUTLINE: This is a dose-escalation study of pemetrexed disodium and sorafenib tosylate.
Patients receive pemetrexed disodium intravenously (IV) on day 1 every 2 weeks and sorafenib tosylate orally (PO) twice daily (BID) on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
- Conditions
- Unspecified Adult Solid Tumor
- Being tested
- sorafenib tosylate, pemetrexed disodium, laboratory biomarker analysis, biopsy
- Keywords
- protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenib tosylateDrug
Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar
Given PO
pemetrexed disodiumDrug
Also called ALIMTA, LY231514, MTA
Given IV
laboratory biomarker analysisOther
Correlative studies
biopsyProcedure or surgery
Also called biopsies
Optional correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (enzyme inhibitor therapy, antiangiogenesis) | Experimental | Patients receive pemetrexed disodium IV on day 1 every 2 weeks and sorafenib tosylate PO BID for 4 weeks on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: sorafenib tosylate; Drug: pemetrexed disodium; Other: laboratory biomarker analysis; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2 doses for the combination of pemetrexed disodium with sorafenib tosylate
Maximum doses of pemetrexed and sorafenib, which, when administered in combination are determined to be tolerable and will be tested in a Phase 2 trial for efficacy.
Measured: At least 4 weeks
Secondary outcomes (4)
Number of subjects in whom study treatment produces antitumor effects of the combination
Tumor masses will be evaluated for response according to the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria v 1.1
Measured: Up to 4 years
Number of biopsy specimens that successfully stain for Beclin1
Determine if biopsy specimens can be stained and analyzed for Beclin1. Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
Measured: Baseline up to 4 weeks
Number of biopsy specimens that can be analyzed for PDGFRb expression
Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
Measured: Baseline up to 4 weeks
Analysis of pTEN expression in biopsy specimens
Assessed by use of a repeated measure analysis through a linear mixed model, as well as an ordinal regression analysis.
Measured: Baseline up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid TumorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew Poklepovic, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450384
- Sponsor's protocol ID
- MCC-13874
- Other IDs
- NCI-2011-03035, P30CA016059
- Status last verified
- Feb 2016
- First submitted
- 30 Sep 2011
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pemetrexed and Sorafenib in Advanced Malignancy
- ClinicalTrials.gov ID
- NCT01450384
- Acronym / sponsor ID
- MCC-13874
- Conditions
- Unspecified Adult Solid Tumor
- Keywords
- protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Oct 2011 (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.
This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of solid tumors by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib tosylate may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To determine doses for the combination of pemetrexed (pemetrexed disodium) with sorafenib (sorafenib tosylate) appropriate for Phase II study.
SECONDARY OBJECTIVES:
- To evaluate the safety, tolerance, and toxicity of the combination of pemetrexed and sorafenib.
II. To observe antitumor effects of the combination.
OUTLINE: This is a dose-escalation study of pemetrexed disodium and sorafenib tosylate.
Patients receive pemetrexed disodium intravenously (IV) on day 1 every 2 weeks and sorafenib tosylate orally (PO) twice daily (BID) on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (enzyme inhibitor therapy, antiangiogenesis) | Experimental | Drug: sorafenib tosylate, Drug: pemetrexed disodium, Other: laboratory biomarker analysis, Procedure: biopsyPatients receive pemetrexed disodium IV on day 1 every 2 weeks and sorafenib tosylate PO BID for 4 weeks on days 1-5. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Advanced solid tumor malignancy for which there is no potentially curative treatment; there is no limit to the number of prior lines of therapy
- Performance status Eastern Cooperative Oncology Group (ECOG) equal or less than 1
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper institutional limit (ULN)
- Total bilirubin =< 1.5 ULN
- Creatinine clearance (CrCl) >= 45 mL/min as measured by the standard Cockcroft-Gault equation
Key exclusion criteria (18 listed)
- Any investigational agent within 4 weeks of first dose of study treatment
- Unwillingness or inability to take folic acid, vitamin B12, or dexamethasone
- Known or presumed intolerance of pemetrexed or sorafenib; unable to swallow medication; suspected malabsorption
- Active illicit substance or alcohol abuse
- Contraindication to antiangiogenic agents, including:
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 |
|---|---|---|
| sorafenib tosylateAlso: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, NexavarGiven PO | Drug | Treatment (enzyme inhibitor therapy, antiangiogenesis) |
| pemetrexed disodiumAlso: ALIMTA, LY231514, MTAGiven IV | Drug | Treatment (enzyme inhibitor therapy, antiangiogenesis) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (enzyme inhibitor therapy, antiangiogenesis) |
| biopsyAlso: biopsiesOptional correlative studies | Procedure or surgery | Treatment (enzyme inhibitor therapy, antiangiogenesis) |
Primary outcome
Recommended phase 2 doses for the combination of pemetrexed disodium with sorafenib tosylate
Time frame: At least 4 weeks
Maximum doses of pemetrexed and sorafenib, which, when administered in combination are determined to be tolerable and will be tested in a Phase 2 trial for efficacy.
4 secondary outcomes
Number of subjects in whom study treatment produces antitumor effects of the combination
Time frame: Up to 4 years
Number of biopsy specimens that successfully stain for Beclin1
Time frame: Baseline up to 4 weeks
Number of biopsy specimens that can be analyzed for PDGFRb expression
Time frame: Baseline up to 4 weeks
Analysis of pTEN expression in biopsy specimens
Time frame: Baseline up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Andrew Poklepovic principal investigator
Massey Cancer Center
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 sorafenib tosylate, pemetrexed disodium and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, run by Virginia Commonwealth University 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 14 inclusion and 18 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: finished, as of the sponsor's last update on 23 Feb 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recommended phase 2 doses for the combination of pemetrexed disodium with sorafenib tosylate (time frame: At least 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.