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CancerPhase 1NCT00485719

Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid Tumors

A Phase 1 study testing XL765 (SAR245409) in people with Cancer, run by Sanofi at 4 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

The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
XL765 (SAR245409)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
4 sitesin 2 countries
Study dates
Jun 2007to Sep 2012
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 metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival.
  • The subject has disease that is assessable by tumor marker, physical, or radiologic means.
  • The subject is at least 18 years old.
  • The subject's weight is at lease 40 kg.
  • The subject has an Eastern Cooperative Oncology Group performance status of 0 - 2.
  • The subject has adequate organ and bone marrow function.
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  • The subject has fasting plasma glucose < 120 mg/dL at screening.
  • for subjects who are to be enrolled into the Expanded MTD Cohort and Lower-Dose Tumor Genetic Alteration Subjects:
  • tumor tissue amenable to serial biopsy;
  • additional informed consent
  • The subject is capable of understanding the protocol and has signed the informed consent.
  • Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
  • If the subject has received more than 3 prior regimens of cytotoxic chemotherapy, more than 2 biologic regimens, or more than 3000 cGy to >25% of his or her bone marrow, the sponsor must determine subject suitability before 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 ≥ 2 years ago, and has had no evidence of disease for 2 years prior to screening for this study.)

Who cannot join

  • The subject has received anticancer treatment (chemotherapy, radiotherapy, cytokines, or hormones) within 30 days (6 weeks for nitrosoureas, mitomycin C, or bicalutamide) before the first dose of XL765.
  • The subject has received radiation to > 25% of his or her bone marrow.
  • The subject has not recovered from adverse events, except Grade 2 alopecia, due to other investigational or other agents administered prior to study enrollment.
  • The subject has received another investigational agent within 30 days or the first dose of XL765 or a small-molecule kinase inhibitor within 14 days or 5 half-lives.
  • The subject is known to have diabetes
  • The subject has uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
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  • The subject has psychiatric illness/social situation that would limit compliance with study requirements.
  • The subject is pregnant or breast feeding.
  • The subject is known to be positive for HIV.
  • The subject has a known allergy or hypersensitivity to components of the XL765 formulation.
  • The subject has a baseline corrected QT interval > 450 ms.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Investigational Site Number 1302

    Detroit, Michigan, 48201

  • Investigational Site Number 1435

    Omaha, Nebraska, 68198

  • Investigational Site Number 1402

    San Antonio, Texas, 78229

Other trials in United States

Spain1 site

  • Investigational Site Number 3411

    Barcelona, 08035

Other trials in Spain

About this study

Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL765 Administered Orally Daily to Subjects With Solid Tumors

The purpose of this study is to determine the safety and tolerability of XL765. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells.

Conditions
Cancer
Being tested
XL765 (SAR245409)
Keywords
Cancer, Solid Tumors
Medical subject headings
Neoplasms

What participants receive

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

  • XL765 (SAR245409)Drug

    Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths administered orally

Study groups in NCT00485719
Study groupRoleWhat they receive
1ExperimentalTwice daily (bid) dosing
Receives: Drug: XL765 (SAR245409)
2ExperimentalOnce daily (qd) dosing
Receives: Drug: XL765 (SAR245409)

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 daily oral administration of XL765 in two treatment schedules

    Measured: Assessed at each visit/periodic visits

Secondary outcomes (2)

  1. Plasma pharmacokinetics of daily oral administration of XL765 in two treatment schedules

    Measured: Assessed at periodic visits

  2. Pharmacodynamic effects of XL765 on tumor tissue when administered at the MTD in two treatment schedules

    Measured: Assessed during periodic vixits after MTD is determined

Timeline

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

  1. First posted13 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionSep 2012
  4. Study completionSep 2012

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
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00485719
Sponsor's protocol ID
TED11440
Other IDs
2007-002437-36, XL765-001
Status last verified
May 2013
First submitted
11 Jun 2007
Last updated
30 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL765 (SAR245409) in people with Cancer, run by Sanofi at 4 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 15 inclusion and 11 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Spain. 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 (MTD) of daily oral administration of XL765 in two treatment schedules (time frame: Assessed at each visit/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 NCT00485719.

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 30 May 2013.

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