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CancerPhase 1NCT00704392

Safety Study of XL647 and XL147 Administered in Combination Daily in Adults With Solid Tumors

A Phase 1 study testing XL647 and XL147 in people with Cancer and Non-small-cell Lung Cancer, run by Exelixis at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine the safety, tolerability, and highest safe doses of XL647 in combination with XL147 in adults with solid tumors. XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), and ErbB2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Non-small-cell Lung Cancer, Breast Cancer
What is being tested?
XL647 and XL147
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jun 2008to Dec 2009
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 histologically confirmed solid tumor that is metastatic or unresectable and is no longer responding to therapies known to prolong survival or to other standard therapies, or has disease for which no standard therapy exists.
  • The subject is ≥ 18 years old.
  • The subject's weight is ≥ 50 kg.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • The subject has a life expectancy of ≥ 3 months.
  • The subject has adequate organ and marrow function.
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  • The subject has a fasting plasma glucose (FPG) < 120 mg/dL at screening.
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
  • Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months after the last dose of protocol drug(s).
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.
  • Subjects in the MTD Expansion Cohort:
  • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
  • Must have a histologically confirmed diagnosis of NSCLC (Stage IIIB or IV) OR a histologically confirmed diagnosis of metastatic breast cancer.

Who cannot join

  • The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of XL647.
  • The subject has received prior treatment with a small molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days before the first dose of XL647.
  • The subject has received any other type of investigational agent within 30 days before the first dose of study treatment.
  • The subject has not recovered from toxicity due to prior therapy.
  • The subject has had major surgery within 30 days before the first dose of study drug. Subjects must have recovered or stabilized from prior surgery.
  • The subject is known to have diabetes.
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  • The subject is currently receiving anticoagulation with warfarin (low-dose warfarin ≤ 1mg/day, heparin, and low-molecular weight heparins are permitted).
  • The subject has prothrombin time (PT)/International Normalized Ratio (INR) and /or partial thromboplastin time (PTT) test results at screening that are above 1.3 times the laboratory upper limit of normal.
  • The subject has any of the following cardiac criteria:
  • Corrected QT interval (QTc) of > 0.46 seconds
  • Has a finding of left bundle branch block
  • Has important bradycardia defined as a heart rate of < 50 bpm due to sinus node dysfunction
  • Has an obligate pacemaker
  • History of sustained ventricular arrhythmias (subjects with a history of atrial arrhythmias should be discussed with the sponsor before entry into the study)
  • Family history of congenital long QT syndrome or unexplained sudden death
  • Has uncontrolled hypertension
  • Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  • The subject requires treatment with drugs known to be associated with torsades de pointes or significant QT interval prolongation.
  • The subject has a serum potassium level or a serum magnesium level that falls outside the normal range.
  • The subject has known brain metastases or a primary brain tumor.
  • The subject has intercurrent illness including but not limited to ongoing or active infection.
  • The subject is known to be positive for the human immunodeficiency virus (HIV).
  • The subject is pregnant or breastfeeding.
  • The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulations
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • South Texas Accelerated Research Therapeutics

    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 XL647 and XL147 Administered in Combination Daily to Subjects With Solid Tumors

The purpose of this study is to determine the safety, tolerability, and highest safe doses of XL647 in combination with XL147 in adults with solid tumors. XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), and ErbB2. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.

Being tested
XL647, XL147
Keywords
Solid tumors, NSCLC
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms

What participants receive

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

  • XL647Drug

    Tablets supplied at 50-mg strength administered orally daily

  • XL147Drug

    Gelatin capsules supplied at 25-mg and 100-mg strengths administered orally daily

Study groups in NCT00704392
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: XL647; Drug: XL147

What is being measured

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

  1. Safety, tolerability, and maximum tolerated dose (MTD) of XL647 administered in combination with XL147 orally daily

    Measured: Assessed at periodic visits

Secondary outcomes (2)

  1. Characterize pharmacokinetic parameters of XL647 administered in combination with XL147 daily in subjects with solid tumors

    Measured: Assessed at periodic visits

  2. Assess pharmacodynamic effects of the XL647 and XL147 combination regimen at the highest safe dose of these agents in subjects with non-small-cell lung cancer or breast cancer

    Measured: Assessed at periodic visits

Timeline

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

  1. First posted24 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2009 (estimated)
  4. Study completionDec 2009 (estimated)

Why it stopped: Study not initiated

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704392
Sponsor's protocol ID
XL647-003
Status last verified
Aug 2015
First submitted
20 Jun 2008
Last updated
20 Aug 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL647 and XL147 in people with Cancer and Non-small-cell Lung Cancer, run by Exelixis 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 13 inclusion and 25 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: withdrawn, as of the sponsor's last update on 20 Aug 2015. 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 was withdrawn before enrolling participants, so there are no results.

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 (MTD) of XL647 administered in combination with XL147 orally daily (time frame: Assessed at periodic visits). 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 NCT00704392.

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 20 Aug 2015.

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