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Non-Small-Cell Lung CancerPhase 1NCT00491699

Safety Study of XL999 in Adults With Non-Small-Cell Lung Cancer

A Phase 1 study testing XL999 in people with Non-Small-Cell Lung Cancer, run by Symphony Evolution, Inc. at 5 sites 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

The purpose of this study is to determine the safest dose of XL999 and how well subjects with Non-Small-Cell Lung Cancer tolerate XL999. XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
XL999
Type of treatment
Injection or infusion
How many people
2 participants
Where
5 sitesUnited States
Study dates
Aug 2007to May 2008
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

  • The subject has a confirmed histological diagnosis of NSCLC.
  • The subject has previously been treated with a platinum- or taxane-containing regimen.
  • The subject has stage IIIB NSCLC with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy).
  • The subject is at least 18 years old.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • The subject has a life expectancy of ≥3 months.
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  • The subject has adequate organ and marrow function.
  • The subject has cardiac-specific enzyme levels (creatine phosphokinase [CPK] total, CPK-MB, and troponin) below the institution's ULN.
  • The subject is capable of understanding the protocol and has signed the informed consent document.
  • Sexually active subjects (male and female) must use medically accepted methods of contraception during the entire course of the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
  • If a subject has received more than three prior regimens of cytotoxic chemotherapy, or more than two biological or targeted therapies, or more than 3000 cGy to >25% of his or her bone marrow, the investigator must discuss with the sponsor regarding subject suitability prior to enrollment.
  • The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥5 years ago, and has had no evidence of disease for 5 years prior to screening for this study).

Who cannot join

  • The subject has received systemic anticancer therapy (eg, chemotherapy, biologic therapy, targeted therapy, cytokines, or hormones) within 14 days before the first dose of study drug.
  • The subject has received radiation to >25% of his or her bone marrow within 30 days of XL999 treatment.
  • The subject has not recovered to Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
  • The subject has history of or known brain metastases, current spinal cord compression, or carcinomatous meningitis.
  • The subject is known to be positive for the human immunodeficiency virus (HIV).
  • The subject has uncontrolled and/or intercurrent illness including but not limited to the following:
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  • Cardiac:
  • Left ventricular ejection fraction (LVEF) assessed by 99mTc multiple-gated acquisition scan (MUGA) is below the institution's lower limit of normal (LLN) at screening. If regional wall motion abnormalities are noted on the MUGA, cardiology consultation should be performed prior to enrollment.
  • History of pulmonary hypertension.
  • History of congestive heart failure (CHF) (New York Heart Association [NYHA] Class II, III, or IV).
  • Active or unstable ischemic disease, including angina pectoris, myocardial infarction, coronary artery bypass grafting (CABG) within the past 12 months.
  • Electrocardiogram (ECG) showing signs of ischemia or myocardial, valvular, or coronary artery disease unless deemed clinically insignificant by a cardiologist.
  • Onset of any changes between the screening ECG and pre-dose ECG unless deemed clinically insignificant by a cardiologist.
  • ECG abnormalities that could cause interpretation difficulties after XL999 administration (eg, left bundle branch block [LBBB], atrial fibrillation, A-V blocks, pacemakers, digoxin).
  • Vascular:
  • Blood pressure >150/90 mm Hg despite antihypertensive therapy with two medications.
  • Cerebrovascular accident, transient ischemic attack, or evidence of active peripheral vascular disease within 12 months prior to study enrollment.
  • Hematologic:
  • National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥3 hemorrhage within 30 days of study enrollment.
  • Evidence of bleeding diathesis or coagulopathy.
  • Requirement for therapeutic anticoagulation. Patients receiving anticoagulants (eg, warfarin, heparin) will be excluded if international normalized ratio >1.5 or partial thromboplastin time (PTT) >1.5× the institution's ULN.
  • Recent surgical procedures:
  • Major surgery or open biopsy within 30 days of starting treatment with XL999.
  • Anticipation of major surgical procedure during the study.
  • Wound healing problems:
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 30 days prior to treatment.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Psychiatric illness that would limit compliance with study requirements.
  • The subject is pregnant or breastfeeding.
  • The subject has a known allergy or hypersensitivity to components of the XL999 formulation.
  • The subject is unable or unwilling to abide by the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Peachtree Hematology Oncology Consultants

    Atlanta, Georgia, 30309

  • Wayne State University, Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Hematology-Oncology Associates of Rockland

    Nyack, New York, 10960

  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer (NSCLC)

The purpose of this study is to determine the safest dose of XL999 and how well subjects with Non-Small-Cell Lung Cancer tolerate XL999. XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

Being tested
XL999
Keywords
NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • XL999Drug

    XL999 will be administered as a once-weekly 4 hour IV infusion as a single agent. The first cohort will be dosed at 0.4 mg/kg IV once weekly. The maximum dose cohort will not exceed 1.6 mg/kg IV once weekly. Ten subjects are planned for each dosing cohort, with dose escalation dependent on safety and available PK data from prior cohorts

What is being measured

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

  1. Safety, tolerability, and maximum tolerated dose of XL999 administered weekly as a 4-hour intravenous infusion

    Measured: Inclusion until 30 days post last treatment

Secondary outcomes (1)

  1. Plasma pharmacokinetics of XL999 administered weekly as a 4-hour intravenous infusion

    Measured: At various time points during the 4 week Treatment Period and the Treatment Extension Period

Timeline

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

  1. First posted26 Jun 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJan 2008
  4. Study completionMay 2008

Why it stopped: The study was stopped due to safety concerns

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00491699
Sponsor's protocol ID
XL999-002
Status last verified
Feb 2010
First submitted
22 Jun 2007
Last updated
19 Feb 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL999 in people with Non-Small-Cell Lung Cancer, run by Symphony Evolution, Inc. at 5 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 13 inclusion and 31 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 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 was stopped early (reason given: The study was stopped due to safety concerns). 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?

Safety, tolerability, and maximum tolerated dose of XL999 administered weekly as a 4-hour intravenous infusion (time frame: Inclusion until 30 days post last treatment). 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 NCT00491699.

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 19 Feb 2010.

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