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Refractory Solid TumorsPhase 1NCT00759928

PK Trial of Sorafenib & Erlotinib in Patients With Refractory Solid Tumors

A Phase 1 study testing Erlotinib and Sorafenib in people with Refractory Solid Tumors, run by SCRI Development Innovations, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Two cohorts of patients will be enrolled: Cohort A will consist of patients who are current smokers, and Cohort B will consist of patients who are current nonsmokers. There will be 24 patients enrolled in each cohort. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Solid Tumors
What is being tested?
Erlotinib and Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesUnited States
Study dates
Oct 2008to Jun 2014
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

None listed.

Who cannot join

  • Patients with untreated brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis. Patients who have a history of brain metastases that has been treated by surgery or radiation therapy > 4 weeks with no signs of Central Nervous System (CNS) progression are allowed.
  • Women who are pregnant or lactating.
  • Patients whose last dose of chemotherapy, immunotherapy, or investigational drug therapy was completed < 21 days prior to receiving study drug
  • Significant cardiac disease within 90 days of starting study treatment including:
  • superior vena cava syndrome;
  • new onset angina;
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  • congestive heart failure (CHF) > Class 2 per New York Heart Association (NYHA) classification (see Appendix B);
  • ventricular arrhythmia;
  • valvular heart disease.
  • Myocardial infarction (MI) within 6 months prior to initiation of study treatment.
  • Cardiomegaly on chest imaging or CHF > Class 2 per NYHA classification (see Appendix B) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution within 3 months of initiating therapy.
  • Poorly controlled hypertension (defined as systolic blood pressure [BP] >150 mmHg and/or diastolic blood pressure >90 mmHg on anti-hypertensive medications).
  • Unstable angina (anginal symptoms at rest).
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
  • A serious active infection (> grade 2) at the time of treatment
  • A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • A major surgical procedure within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
  • Any minor surgery must be completed within 7 days prior to beginning study treatment.
  • Use of rifampin, St. John's wort, or other potent inducers of CYP3A4 are not permitted from Day -14 through Day 15 of the study (see Appendix C).
  • Use of ketoconazole and other potent inhibitors of CYP3A4 are not permitted from Day -14 through Day 15 of the study (see Appendix C).
  • Stroke or transient ischemic attack (TIA) within the past 6 months.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • Pulmonary hemorrhage/bleeding event > grade 2 within 28 days of study treatment.
  • Any other non-pulmonary hemorrhage/bleeding event> grade 3 within 28 days of study treatment.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
  • Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease.
  • Patients who smoke 1-9 cigarettes per day during the year before study entry or patients who have smoked for <1 year will not be eligible for this study.
  • Any condition that impairs the patient's ability to swallow whole pills.
  • Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Tennessee Oncology

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Pharmacokinetic Trial of Sorafenib and Erlotinib in Patients With Refractory Solid Tumors

Two cohorts of patients will be enrolled: Cohort A will consist of patients who are current smokers, and Cohort B will consist of patients who are current nonsmokers. There will be 24 patients enrolled in each cohort. Nonsmokers are patients who have not consumed tobacco or nicotine-containing products for 1 year before the start of the study. Patients classified as current smokers must have smoked a minimum of 10 cigarettes per day for up to 1 year. Patients who have smoked 1-9 cigarettes per day for up to 1 year, or more than 10 cigarettes per day for less than 1 year will not be eligible for this study.

Read the detailed description

Compared with supportive care alone, erlotinib has been associated with improved overall survival in patients with Refractory Solid Tumors; however, this absolute benefit is limited for the majority of patients. Incorporating other biologic agents into the second- or third-line treatment setting may prove to be a successful strategy in improving treatment efficacy (which has been recently demonstrated in several tumor types). Additionally, recent data suggest that smoking may influence the pharmacokinetic (PK) profile of erlotinib by increasing the metabolic clearance. Data suggest that the geometric mean erlotinib AUC(0-inf) and C(24h) are significantly decreased in smokers compared with nonsmokers (Hamilton et al. 2006). For this reason, this trial will enroll separate cohorts of patients who are current smokers and patients who are nonsmokers. Nonsmokers are patients who have not consumed tobacco or nicotine-containing products for 1 year before the start of the study. Patients classified as current smokers must have smoked a minimum of 10 cigarettes per day for up to 1 year.

Being tested
Erlotinib, Sorafenib
Keywords
Refractory Solid Tumors, Unresectable Stage III/IV, Sorafenib, Erlotinib, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErlotinibDrug

    Also called Tarceva

    150 mg once daily by mouth

  • SorafenibDrug

    Also called Nexavar

    400 mg twice daily by mouth

Study groups in NCT00759928
Study groupRoleWhat they receive
Erlotinib/SorafenibExperimentalPatients will receive erlotinib 150 mg once daily by mouth and sorafenib 400 mg twice daily by mouth. The study will begin with a 2-week run-in period (which will begin on Day 14 of the study, and continue through Day 1 of the study), in which erlotinib will be dosed alone at 150 mg once daily. Patients will continue taking erlotinib as a single agent at 150 mg once daily through Day 1. After the 2-week run-in period, patients will receive continuous dosing of both agents (erlotinib 150 mg once daily and sorafenib 400 mg twice daily) in cycles of 28 days each. Toxicity will be assessed every cycle (every 4 weeks) for all patients. Because this is not an efficacy study, restaging tumor measurements will be at the discretion of the physician every 8 weeks during treatment. Patients with objective response or stable disease will continue therapy; patients with disease progression or unacceptable toxicity will be discontinued from the study.
Receives: Drug: Erlotinib; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the pharmacokinetics (PK) of erlotinib when administered in combination with sorafenib on a continuous schedule in Refractory Solid Tumors in patients who are smokers and in patients who are nonsmokers.

    Measured: 3 months

Secondary outcomes (1)

  1. To evaluate safety of this combination in patients with Refractory Solid Tumors.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionSep 2013
  4. Study completionJun 2014

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00759928
Sponsor's protocol ID
SCRI LUN 175
Status last verified
Jul 2014
First submitted
24 Sep 2008
Last updated
2 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erlotinib and Sorafenib in people with Refractory Solid Tumors, run by SCRI Development Innovations, LLC at 2 sites 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 0 inclusion and 32 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 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

To determine the pharmacokinetics (PK) of erlotinib when administered in combination with sorafenib on a continuous schedule in Refractory Solid Tumors in patients who are smokers and in patients who are nonsmokers. (time frame: 3 months). 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 NCT00759928.

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 2 Jul 2014.

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