CancerPhase 1NCT00777699
Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
A Phase 1 study testing XL765 (SAR245409) and erlotinib in people with Cancer and Non-Small Cell Lung Cancer, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. 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?
- XL765 (SAR245409) and erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Feb 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
- Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or metastatic NSCLC that has previously been treated with erlotinib or gefitinib
- ECOG Performance Status 0-1
- Adequate organ and bone arrow function as defined by hematological and serum chemistry limits
- At least 18 years old
- Both men and women must practice adequate contraception
- Informed consent
Who cannot join
- Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
- Erlotinib intolerant
- Taking oral corticosteroids chronically or > 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus and an HgbA1c > 7%
- Uncontrolled intercurrent illness
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- Pregnant or breastfeeding
- Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
- HIV positive
- Diagnosis of another malignancy may exclude subject from study
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational Site Number 168983
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. 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. 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.
- Conditions
- Cancer, Non-Small Cell Lung Cancer
- Being tested
- XL765 (SAR245409), 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.
XL765 (SAR245409)Drug
Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing
erlotinibDrug
Also called Tarceva®
Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: XL765 (SAR245409); Drug: erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib
Measured: Assessed during periodic visits
Secondary outcomes (2)
To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination
Measured: Assessed during periodic visits
To evaluate preliminary efficacy of XL765 in combination with erlotinib in subjects with non-small-cell lung cancer (NSCLC) and other 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.
- First posted22 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777699
- Sponsor's protocol ID
- TED11442
- Other IDs
- 2008-003219-11, XL765-003, 2008
- Status last verified
- Feb 2012
- First submitted
- 20 Oct 2008
- Last updated
- 3 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00777699
- Acronym / sponsor ID
- TED11442
- Conditions
- Cancer, Non-Small Cell Lung Cancer
- Keywords
- Cancer, Solid Tumors, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: XL765 (SAR245409), Drug: erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of:
- ECOG Performance Status 0-1
- Adequate organ and bone arrow function as defined by hematological and serum chemistry limits
- At least 18 years old
- Both men and women must practice adequate contraception
Key exclusion criteria (10 listed)
- Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
- Erlotinib intolerant
- Taking oral corticosteroids chronically or > 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus and an HgbA1c > 7%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XL765 (SAR245409)Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; daily dosing | Drug | 1 |
| erlotinibAlso: Tarceva®Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing | Drug | 1 |
Primary outcome
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib
Time frame: Assessed during periodic visits
2 secondary outcomes
To evaluate plasma pharmacokinetics of XL765 and erlotinib when administered in combination
Time frame: Assessed during periodic visits
To evaluate preliminary efficacy of XL765 in combination with erlotinib in subjects with non-small-cell lung cancer (NSCLC) and other solid tumors
Time frame: Assessed during periodic visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XL765 (SAR245409) 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 8 inclusion and 10 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 Feb 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 XL765 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?
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 Feb 2012.