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Non-small Cell Lung Cancer (NSCLC), RecurrentPhase 1NCT01515969

Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)

A Phase 1 study testing Erlotinib hydrochloride and Dovitinib lactate in people with Non-small Cell Lung Cancer (NSCLC), Recurrent and Non-small Cell Lung Cancer (NSCLC), Stage IV, run by Heather Wakelee at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer and dovitinib blocks the fibroblast growth… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Erlotinib hydrochloride and Dovitinib lactate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Jul 2012to Dec 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

  • Histologically-confirmed metastatic non-small cell lung cancer
  • One or more primary or metastatic lesions measurable in at least one dimension by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v1.1) within 4 weeks prior to entry of study
  • Patients who have failed any number of prior therapies, including those previously treated with erlotinib
  • Life expectancy > 2 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500/mm^3)
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  • Platelets (PLT) >= 100,000/mm^3
  • Hemoglobin (Hgb) >= 9 g/dL
  • Serum creatinine =< 1.5 x upper limit of normal (ULN)
  • Serum bilirubin =< 1.5 x ULN (regardless of whether liver metastases are present at baseline)
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) =< 3.0 x ULN (regardless of whether liver metastases are present at baseline)
  • Ability to understand and the willingness to provide verbal and written informed consent
  • Patients - both males and females- with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Who cannot join

  • Patients who have received the last administration of chemotherapy or immunotherapy =< the timeframe defined below after the end of the cycle of the last treatment, prior to starting study drug, or who have not recovered from the side effects of such therapy:
  • Patients who have received the last administration of chemotherapy/immunotherapy in a daily schedule =< 7 days prior to starting study drug
  • Patients who have received the last administration of chemotherapy/immunotherapy in a weekly schedule =< 2 weeks prior to starting study drug
  • Patients who have received the last administration of chemotherapy/immunotherapy in a 2-weekly schedule =< 3 weeks prior to starting study drug
  • Patients who have received the last administration of chemotherapy/immunotherapy in a 3-weekly schedule =< 4 weeks prior to starting study drug
  • Patients who have received the last administration of chemotherapy/immunotherapy in a 4-weekly schedule =< 5 weeks prior to starting study drug
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  • Patients who have received the last administration of nitrosourea, mitomycin-C =< 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who have undergone major surgery =< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • If history of other primary cancer, subject will be eligible only if she or he has:
  • Curatively resected non-melanomatous skin cancer, basal cell carcinoma, squamous cell carcinoma
  • Curatively treated cervical carcinoma in situ
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
  • Subjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT > 2.5 x ULN)
  • History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
  • Patients who continue to smoke (given that smoking decreases serum levels of erlotinib)
  • Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to enrollment
  • Any of the following concurrent severe and/or uncontrolled medical conditions within 6 months of enrollment which could compromise participation in the study:
  • Unstable angina pectoris
  • Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication; initiation or adjustment of antihypertensive medication(s) is allowed prior to study entry
  • Left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever is higher)
  • Myocardial infarction
  • Serious uncontrolled ventricular arrhythmia
  • Clinically significant resting bradycardia
  • Uncontrolled diabetes
  • Transient Ischemic Attach (TIA)
  • Cerebrovascular accident (CVA)
  • Pulmonary embolism (PE)
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Serious active or uncontrolled infection
  • Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • Chronic renal disease
  • Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin or enoxaparin
  • Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment; oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test =< 14 days prior to starting study treatment
  • Patients unwilling to or unable to comply with the protocol
  • There may be danger of harm to study participants because of human immunodeficiency virus (HIV) comorbidity or drug interactions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase I Study of Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer

This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may be important to treat lung cancer. The combination of both drugs may work better than either drug alone, but may also have increased side effects. This trial will look at the side effects of combining the drugs and look for how effective the combination may be.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To characterize the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and dovitinib (dovitinib lactate), assessing for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

II. To determine the maximum tolerated dose (MTD) of the combination of erlotinib and dovitinib.

SECONDARY OBJECTIVES:

  1. To evaluate overall response rate (ORR), progression free survival (PFS), and overall survival (OS) of patients receiving the combination of erlotinib and dovitinib, although this phase will allow for patients who received any number of prior treatments, including prior treatment with erlotinib.

II. To evaluate the potential impact of dovitinib on erlotinib pharmacokinetics (PK).

OUTLINE: This is a dose-escalation study.

Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months.

Being tested
Erlotinib hydrochloride, Dovitinib lactate
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Recurrence

What participants receive

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

  • Erlotinib hydrochlorideDrug

    Also called Erlotinib HCl, Tarceva, CP-358,774, OSI-774

    Given PO

  • Dovitinib lactateDrug

    Also called CHIR-258, Receptor tyrosine kinase (RTK) inhibitor TKI258, TKI258

    Given PO

Study groups in NCT01515969
Study groupRoleWhat they receive
Treatment (enzyme inhibitor therapy)ExperimentalPatients receive erlotinib hydrochloride PO QD. Starting on day 15, patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Erlotinib hydrochloride; Drug: Dovitinib lactate

What is being measured

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

  1. Measure toxicity to determine the MTD of the combination of erlotinib hydrochloride and dovitinib lactate

    Dose limiting toxicity (DLT) is defined as a CTCAE v4.0 toxicity >= grade 3 or 4 occurring after 3 weeks of treatment. If 2 of 6 patients experience a DLT, then the MTD will be defined as the dose tolerated by the cohort preceding the cohort experiencing the DLT.

    Measured: 1 year

Secondary outcomes (3)

  1. ORR (complete response [CR]+ partial response [PR])

    Measured: 1 year

  2. PFS

    Measured: 1 year

  3. OS

    Measured: 1 year

Timeline

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

  1. First posted24 Jan 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionFeb 2013
  4. Study completionDec 2014

Why it stopped: Patient safety - Unacceptable toxicity

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
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515969
Sponsor's protocol ID
IRB-21659
Other IDs
IRB-18952, LUN0044, NCI-2011-03333, SU-08012011-8166
Status last verified
Jul 2016
First submitted
16 Dec 2011
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erlotinib hydrochloride and Dovitinib lactate in people with Non-small Cell Lung Cancer (NSCLC), Recurrent and Non-small Cell Lung Cancer (NSCLC), Stage IV, run by Heather Wakelee 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 13 inclusion and 37 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 Jul 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 was stopped early (reason given: Patient safety - Unacceptable toxicity). 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?

Measure toxicity to determine the MTD of the combination of erlotinib hydrochloride and dovitinib lactate (time frame: 1 year). 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 NCT01515969.

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 Jul 2016.

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