CancerPhase 1NCT00756847
Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors
A Phase 1 study testing XL147 (SAR245408),, paclitaxel and carboplatin in people with Cancer and Non-Small Cell Lung Cancer, run by Sanofi at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults 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, Endometrial Carcinoma
- What is being tested?
- XL147 (SAR245408),, paclitaxel and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2008to 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
- Confirmed diagnosis of:
- Advanced solid tumor that is no longer responding to therapies OR
- Advanced or recurrent endometrial carcinoma OR
- Advanced or recurrent ovarian carcinoma OR
- Unresectable (Stage IIIB or IV) NSCLC
- ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion and agreement with sponsor)
Show all 10Show fewer
- Adequate organ and bone marrow 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, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
- Known allergy or hypersensitivity to any of the components of the treatment formulations
- Taking oral corticosteroids chronically or > 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus.
- Uncontrolled intercurrent illness
Show all 10Show fewer
- 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
4 sites in 1 country.
United States4 sites
Investigational Site Number
Houston, Texas, 77030-4009
Investigational Site Number
Madison, Wisconsin, 53792-6164
Investigational Site Number
Oklahoma City, Oklahoma, 73104
Investigational Site Number
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Combination With Paclitaxel and Carboplatin in Subjects With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults 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. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).
- Being tested
- XL147 (SAR245408),, paclitaxel, carboplatin
- Keywords
- Solid Tumors, NSCLC, Ovarian Cancer, Endometrial Cancer
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Endometrial Neoplasms, Ovarian Neoplasms
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- and 100-mg strengths; daily dosing
paclitaxelDrug
Also called Taxol®
Intravenous injection dosed once every three weeks
carboplatinDrug
Intravenous injection dosed once every three weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: XL147 (SAR245408),; Drug: paclitaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 175 mg/m2) and carboplatin in subjects with advanced solid tumors
Measured: Assessed at periodic visits
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 225 mg/m2) and carboplatin in subjects with NSCLC
Measured: Assessed at periodic visits
Secondary outcomes (3)
To investigate the relationship between selected biomarkers and efficacy and safety outcomes
Measured: Assessed at periodic visits
To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination
Measured: Assessed at periodic visits
To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel
Measured: Assessed at 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 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 52 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
- NCT00756847
- Sponsor's protocol ID
- TED11435
- Other IDs
- XL147-003
- Status last verified
- Apr 2013
- First submitted
- 18 Sep 2008
- Last updated
- 10 Apr 2013
- Results posted
- No
Publications
Wheler J, Mutch D, Lager J, Castell C, Liu L, Jiang J, Traynor AM. Phase I Dose-Escalation Study of Pilaralisib (SAR245408, XL147) in Combination with Paclitaxel and Carboplatin in Patients with Solid Tumors. Oncologist. 2017 Apr;22(4):377-e37. doi: 10.1634/theoncologist.2016-0257. Epub 2017 Mar 8.
PubMed 28275119
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Combination With Paclitaxel and Carboplatin in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00756847
- Acronym / sponsor ID
- TED11435
- Keywords
- Solid Tumors, NSCLC, Ovarian Cancer, Endometrial Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Sep 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 XL147 in combination with paclitaxel and carboplatin in adults 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. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).
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: XL147 (SAR245408),, Drug: paclitaxel, Drug: carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed diagnosis of:
- ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion and agreement with sponsor)
- Adequate organ and bone marrow 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, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
- Known allergy or hypersensitivity to any of the components of the treatment formulations
- Taking oral corticosteroids chronically or > 1 mg/day warfarin
- Not recovered from the toxic effects of prior therapy
- History of diabetes mellitus.
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 |
|---|---|---|
| XL147 (SAR245408),Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing | Drug | 1 |
| paclitaxelAlso: Taxol®Intravenous injection dosed once every three weeks | Drug | 1 |
| carboplatinIntravenous injection dosed once every three weeks | Drug | 1 |
Primary outcome
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 175 mg/m2) and carboplatin in subjects with advanced solid tumors
Time frame: Assessed at periodic visits
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 225 mg/m2) and carboplatin in subjects with NSCLC
Time frame: Assessed at periodic visits
3 secondary outcomes
To investigate the relationship between selected biomarkers and efficacy and safety outcomes
Time frame: Assessed at periodic visits
To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination
Time frame: Assessed at periodic visits
To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel
Time frame: Assessed at 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 10 Apr 2013.
- Derived from this study: PubMed 28275119Wheler J, Mutch D, Lager J, Castell C, Liu L, Jiang J, Traynor AM. Phase I Dose-Escalation Study of Pilaralisib (SAR245408, XL147) in Combination with Paclitaxel and Carboplatin in Patients with Solid Tumors. Oncologist. 2017 Apr;22(4):377-e37. doi: 10.1634/theoncologist.2016-0257. Epub 2017 Mar 8.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XL147 (SAR245408),, paclitaxel and carboplatin in people with Cancer and Non-Small Cell Lung Cancer, run by Sanofi at 4 sites 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 10 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 10 Apr 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. 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?
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 175 mg/m2) and carboplatin in subjects with advanced solid tumors (time frame: Assessed at 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 NCT00756847, 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 10 Apr 2013.