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Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors

Primary Purpose

Cancer, Non-Small Cell Lung Cancer, Endometrial Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XL147 (SAR245408),
paclitaxel
carboplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Solid Tumors, NSCLC, Ovarian Cancer, Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Investigational Site Number
  • Investigational Site Number
  • Investigational Site Number
  • Investigational Site Number

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

To investigate the relationship between selected biomarkers and efficacy and safety outcomes
To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination
To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel

Full Information

First Posted
September 18, 2008
Last Updated
April 9, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00756847
Brief Title
Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Non-Small Cell Lung Cancer, Endometrial Carcinoma, Ovarian Carcinoma
Keywords
Solid Tumors, NSCLC, Ovarian Cancer, Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
XL147 (SAR245408),
Intervention Description
Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol®
Intervention Description
Intravenous injection dosed once every three weeks
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Intravenous injection dosed once every three weeks
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
To investigate the relationship between selected biomarkers and efficacy and safety outcomes
Time Frame
Assessed at periodic visits
Title
To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination
Time Frame
Assessed at periodic visits
Title
To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel
Time Frame
Assessed at periodic visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigational Site Number
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Investigational Site Number
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28275119
Citation
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.
Results Reference
derived

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Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors

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