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CancerPhase 1NCT00692640

Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors

A Phase 1 study testing XL147 (SAR245408) and Erlotinib in people with Cancer and Non-small Cell Lung Cancer, run by Sanofi at 1 site 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

The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. 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
What is being tested?
XL147 (SAR245408) and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
May 2008to Nov 2011
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

  • Subjects accrue to one of two phases:
  • in the Dose Escalation Phase, 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 or for which monotherapy with erlotinib is considered standard therapy.
  • in the Cohort Expansion Phase, the subject has advanced or metastatic NSCLC that is no longer responding to therapies known to prolong survival or to other standard therapies and which:
  • has been previously or currently treated with erlotinib or gefitinib or
  • with the agreement of the sponsor, has been previously or is currently treated with other EGFR/VEGFR tyrosine kinase inhibitors
  • The subject has measurable or non-measurable lesions by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
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  • At least 10 unstained slides of tumor tissue, archival or fresh, or paraffin block or a fresh tumor biopsy are identified and designated for central laboratory analysis.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • The subject has adequate organ and marrow function.
  • The subject has a fasting plasma glucose ≤ 120 mg/dL at screening.
  • The subject is ≥ 18 years old.
  • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
  • Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for at least 3 months after the last dose of protocol drug(s).
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.

Who cannot join

  • The subject has previously been treated with a selective PI3K inhibitor.
  • The subject has received:
  • cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (antibodies, immune modulators, cytokines) within 3 weeks or has received nitrosoureas or mitomycin C within 6 weeks before the scheduled first dose of XL147
  • a small-molecule kinase inhibitor (including investigational small molecule kinase inhibitors) excluding small-molecule inhibitors of EGFR or non-cytotoxic hormonal agent within 14 days of the scheduled first dose of XL147
  • other investigational therapy (ie, not specified in exclusion criterion) within 28 days of the first scheduled dose of XL147
  • The subject has not recovered from toxicity due to prior therapy to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or less (except alopecia).
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  • The subject has a diagnosis of uncontrolled diabetes mellitus.
  • The subject is currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day, heparin, and low-molecular weight heparins are permitted).
  • The subject is taking oral corticosteroids chronically.
  • The subject has prothrombin time/International Normalized Ratio and/or partial thromboplastin time test results at screening that are above 1.3x the laboratory upper limit of normal.
  • The subject has uncontrolled intercurrent illness including but not limited to an active infection or hypertension that would limit compliance with study requirements.
  • The subject has had congestive heart failure, unstable angina, a myocardial infarction, or a stroke within 3 months of entering the study.
  • The subject has a baseline corrected QT interval (QTc) ≥ 460 ms.
  • The subject has psychiatric illness/social situation(s) that would limit compliance with study requirements.
  • The subject is known to be positive for the human immunodeficiency virus.
  • The subject has a previously identified allergy or hypersensitivity to components of the XL147 formulation.
  • The subject is pregnant or breastfeeding.
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Investigational Site Number 1214

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Study of XL147 (SAR245408) in Combination With Erlotinib in Subjects With Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with erlotinib (Tarceva®) in subjects with solid tumors. 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. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Being tested
XL147 (SAR245408), Erlotinib
Keywords
Cancer, Solid Tumors, NSCLC
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • XL147 (SAR245408)Drug

    Gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing for 21 days/7 days off

  • ErlotinibDrug

    Also called Tarceva®

    Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing

Study groups in NCT00692640
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: XL147 (SAR245408); Drug: Erlotinib

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 XL147 administered in combination with erlotinib

    Measured: Assessed during periodic visits

Secondary outcomes (2)

  1. To evaluate plasma pharmacokinetics of XL147 and erlotinib when administered in combination

    Measured: Assessed during periodic visits

  2. To evaluate preliminary efficacy of XL147 in combination with erlotinib in adults with refractory solid tumors

    Measured: Assessed during 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 posted6 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionNov 2011
  4. Study completionNov 2011

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00692640
Sponsor's protocol ID
TED11434
Other IDs
XL147-002
Status last verified
Mar 2012
First submitted
3 Jun 2008
Last updated
23 Mar 2012
Results posted
No

Publications

  • Soria JC, LoRusso P, Bahleda R, Lager J, Liu L, Jiang J, Martini JF, Mace S, Burris H. Phase I dose-escalation study of pilaralisib (SAR245408, XL147), a pan-class I PI3K inhibitor, in combination with erlotinib in patients with solid tumors. Oncologist. 2015 Mar;20(3):245-6. doi: 10.1634/theoncologist.2014-0449. Epub 2015 Feb 10.

    PubMed 25669662

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL147 (SAR245408) and Erlotinib in people with Cancer and Non-small Cell Lung Cancer, run by Sanofi 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 Mar 2012. 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?

Safety, tolerability, and maximum tolerated dose of XL147 administered in combination with erlotinib (time frame: Assessed during 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 NCT00692640, which also lists 1 linked publication.

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 Mar 2012.

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