AzTrials
AzTrials

CancerPhase 1NCT00486135

Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma

A Phase 1 study testing XL147 (SAR245408) in people with Cancer and Lymphoma, 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
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated. 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, Lymphoma
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
118 participants
Where
4 sitesin 2 countries
Study dates
Jun 2007to Oct 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 solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. An expanded cohort will be enrolled; NSCLC subjects enrolled must have a diagnosis of relapsed or refractory NSCLC (Stage IIIB or IV) and have received at least two prior regimens including one platinum-based chemotherapy regimen.
  • The subject has a histologically confirmed diagnosis of lymphoma which is relapsed or refractory to standard therapy.
  • For subjects with solid tumors, the subject has disease that is assessable by tumor marker, physical, or radiologic means. There are separate criteria that apply to subjects with lymphoma.
  • Subjects with indolent lymphoma must have documented disease status within 12 months prior to study entry.
  • The subject is ≥18 years old.
  • The subject's weight is ≥40 kg.
Show all 15Show fewer
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • The subject has adequate organ and marrow function, and a fasting plasma glucose (FPG) <160 mg/dL and HbA1c of <8% at screening.
  • For the subjects with solid tumors who are to be enrolled into the expanded MTD cohort and tumor genetic alteration subjects:
  • tumor tissue amenable to serial biopsy, and
  • additional informed consent.
  • 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 use medically acceptable methods of contraception during the course of the study and for 3 months following discontinuation of study drug.
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
  • At least ten 4-10 micron tissue sections, archival or fresh, or a tissue block, of the subject's tumor should be identified and designated for shipment to the sponsor where allowed by local regulatory bodies. For subjects with lymphoma, tissue from an excisional or core biopsy or, in case of marrow involvement, a bone marrow aspirate/biopsy is acceptable.

Who cannot join

  • The subject has previously been treated with a selective PI3K inhibitor.
  • Additional restrictions on prior treatment apply.
  • For lymphoma subjects: known central nervous system involvement, autoimmune disease requiring immunosuppressive therapy, systemic treatment with prednisone >20mg/day or equivalent within 2 weeks prior to first dose of XL147, autologous stem cell transplantation within 12 weeks prior to first dose, history of any allogeneic transplantation.
  • The subject has not recovered from toxicity due to all prior therapies.
  • The subject has a primary brain tumor. Subjects with brain metastasis are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
  • The subject is currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin is permitted).
Show all 14Show fewer
  • The subject has prothrombin time/partial thromboplastin time (PT/PTT) or International Normalized Ratio (INR) test results at screening that are above 1.3x the laboratory upper limit of normal.
  • The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • The subject has psychiatric illness/social situation(s) that would limit compliance with study requirements.
  • The subject is pregnant or breastfeeding.
  • The subject is known to be positive for the human immunodeficiency virus (HIV).
  • The subject has a previously identified allergy or hypersensitivity to components of the XL147 formulation.
  • The subject has a baseline corrected QT interval (QTc) >460 ms.
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Investigational Site Number 1241

    Augusta, Georgia, 30912

  • Investigational Site Number 1503

    Boston, Massachusetts, 02115

  • Investigational Site Number 1401

    Dallas, Texas, 75230

Other trials in United States

Spain1 site

  • Investigational Site Number 3412

    Barcelona, 08035

Other trials in Spain

About this study

Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 Administered Orally Daily to Subjects With Solid Tumors or Lymphoma

The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. Both a capsule and a tablet formulation will be evaluated. 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.

Conditions
Cancer, Lymphoma
Being tested
XL147 (SAR245408)
Keywords
Cancer, Solid tumors, Lymphoma
Medical subject headings
Neoplasms, Lymphoma

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 dosage strengths

  • XL147 (SAR245408)Drug

    Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths

Study groups in NCT00486135
Study groupRoleWhat they receive
1ExperimentalDaily dosing for 21 days/7 days off
Receives: Drug: XL147 (SAR245408)
2ExperimentalContinuous daily dosing
Receives: Drug: XL147 (SAR245408)
3ExperimentalContinuous daily dosing
Receives: Drug: XL147 (SAR245408)

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 oral administration of two formulations of XL147 in two treatment schedules

    Measured: Assessed at each visit/periodic visits

  2. Safety and tolerability of oral dosing with XL147 capsules in subjects with lymphoma, and of XL147 capsules and tablets in subjects with solid tumors

    Measured: Assessed at periodic study visits

Secondary outcomes (3)

  1. Plasma pharmacokinetics of daily oral administration of XL147 in two treatment schedules

    Measured: Assessed during periodic visits

  2. Pharmacodynamic effects of XL147 on tumor tissue when administered at the maximum tolerated dose in two treatment schedules

    Measured: Assessed during periodic visits after MTD is determined

  3. Plasma pharmacokinetics of XL147 capsule and tablet formulations

    Measured: Assessed during periodic visits after the preliminary MTD for the continuous daily dosing schedule 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 completionOct 2012
  4. Study completionOct 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
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00486135
Sponsor's protocol ID
TED11433
Other IDs
XL147-001
Status last verified
Jan 2013
First submitted
11 Jun 2007
Last updated
1 Feb 2013
Results posted
No

Publications

  • Edelman G, Rodon J, Lager J, Castell C, Jiang J, Van Allen EM, Wagle N, Lindeman NI, Sholl LM, Shapiro GI. Phase I Trial of a Tablet Formulation of Pilaralisib, a Pan-Class I PI3K Inhibitor, in Patients with Advanced Solid Tumors. Oncologist. 2018 Apr;23(4):401-e38. doi: 10.1634/theoncologist.2017-0691. Epub 2018 Mar 28.

    PubMed 29593099

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL147 (SAR245408) in people with Cancer and Lymphoma, 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 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 1 Feb 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 of oral administration of two formulations of XL147 in two treatment schedules (time frame: Assessed at each visit/periodic visits). 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 NCT00486135, 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 1 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in