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Endometrial CancerPhase 2NCT01013324

Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

A Phase 2 study testing XL147 (SAR245408) in people with Endometrial Cancer and Endometrial Neoplasms, run by Sanofi at 13 sites in 2 countries.

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

There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer, Endometrial Neoplasms
What is being tested?
XL147 (SAR245408)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
13 sitesin 2 countries
Study dates
Jan 2010to Mar 2013
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has a histologically confirmed diagnosis of EC (endometrioid, serous, clear cell adenocarcinoma, adenosquamous carcinoma, or mixed histology, any grade) that is advanced (ie, persistent, locally advanced) or recurrent, and is incurable by standard therapies and has received one platinum based chemotherapy regimen for EC.
  • The subject is at least 18 years old.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The subject has at least one measurable lesion
  • Tissue samples from archival or fresh tissue, or a tissue block of the subject's tumor
  • The subject has adequate organ and marrow function
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  • The subject is capable of understanding the informed consent and complying with the protocol and has signed the informed consent document before any study-specific screening procedures or evaluations are performed.
  • Sexually active subjects of childbearing potential and their partners must agree to use medically accepted methods of contraception during the course of the study and for 3 months after discontinuation of study drug.
  • 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, mTOR inhibitor, or AKT inhibitor.
  • The subject has uterine sarcomas (leiomyosarcoma), mixed Mullerian tumors, squamous carcinoma of the uterus, and/or adenosarcomas of the uterus.
  • Certain restrictions on prior treatments apply
  • The subject has not recovered from toxicity due to prior therapy to Grade ≤ 1 or to pre-therapy baseline (excluding alopecia and peripheral neuropathy).
  • The subject has a known primary brain tumor or brain metastasis.
  • The subject has any other diagnosis of malignancy or evidence of malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix) within 2 years before screening for this study.
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  • The subject has a diagnosis of uncontrolled diabetes mellitus or has a fasting plasma glucose > 160 mg/dL.
  • The subject is currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1 mg/day is permitted).
  • The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening that are above 1.3 x the laboratory upper limit of normal.
  • The subject has uncontrolled, significant intercurrent illness
  • The subject has a baseline corrected QT interval ≥ 470 ms.
  • The subject is known to be positive for the human immunodeficiency virus (HIV). (Note: Baseline HIV screening is not required.)
  • The subject is pregnant or breastfeeding.
  • The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States10 sites

  • Investigational Site Number 1132

    Abington, Pennsylvania, 19001

  • Investigational Site Number 1239

    Augusta, Georgia, 30912

  • Investigational Site Number 1133

    Boston, Massachusetts, 02115

  • Investigational Site Number 1325

    Columbus, Ohio, 43210

  • Investigational Site Number 1527

    Dallas, Texas, 75230

  • Investigational Site Number 1526

    Newport Beach, California, 92663

  • Investigational Site Number 1434

    Oklahoma City, Oklahoma, 73084

  • Investigational Site Number 1532

    Orlando, Florida, 32806

  • Investigational Site Number 1134

    Philadelphia, Pennsylvania, 19111

  • Investigational Site Number 1142

    Providence, Rhode Island, 02905

Other trials in United States

Belgium3 sites

  • Investigational Site Number 3212

    Kortrijk, 8500

  • Investigational Site Number 3211

    Leuven, 3000

  • Investigational Site Number 3218

    Wilrijk, 2610

Other trials in Belgium

About this study

Official title: A Phase 2 Study of XL147 (SAR245408) in Subjects With Advanced or Recurrent Endometrial Carcinoma

There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC.

Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.

Being tested
XL147 (SAR245408)
Keywords
endometrial cancer, endometrial carcinoma, carcinoma of the endometrium, cancer of the endometrium
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • XL147 (SAR245408)Drug

    dosed as capsules taken orally daily

Study groups in NCT01013324
Study groupRoleWhat they receive
Single ArmExperimentalAll subjects will receive single-agent XL147 dosed daily
Receives: Drug: XL147 (SAR245408)

What is being measured

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

  1. Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months

    Measured: every 8-10 weeks

  2. Safety of XL147 in the EC population

    Measured: scheduled evaluations every 2-4 weeks

Secondary outcomes (2)

  1. Duration of response and PFS

    Measured: every 8-10 weeks

  2. Characterize pharmacokinetic and pharmacodynamic profiles of XL147

    Measured: at periodic visits not less than every 4 weeks

Timeline

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

  1. First posted13 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01013324
Sponsor's protocol ID
ARD11436
Other IDs
XL147-201
Status last verified
May 2016
First submitted
10 Nov 2009
Last updated
3 Jun 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XL147 (SAR245408) in people with Endometrial Cancer and Endometrial Neoplasms, run by Sanofi at 13 sites in 2 countries.

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 9 inclusion and 14 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months (time frame: every 8-10 weeks). The study lists 2 primary outcomes in all. 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 NCT01013324.

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 3 Jun 2016.

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