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| ID | Type | Description | Link |
|---|---|---|---|
| XL147-003 | Other Identifier | (Other study code) |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XL147 (SAR245408), | Drug | Gelatin capsules supplied in 25- and 100-mg strengths; daily dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Assessed at periodic visits |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the relationship between selected biomarkers and efficacy and safety outcomes | Assessed at periodic visits | |
| To assess plasma pharmacokinetics (PK) of XL147, paclitaxel, and carboplatin when used in combination | Assessed at periodic visits |
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Inclusion Criteria:
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
Informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number | St Louis | Missouri | 63110 | United States | ||
| Investigational Site Number |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28275119 | Derived | 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. |
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| paclitaxel |
| Drug |
Intravenous injection dosed once every three weeks |
|
|
| carboplatin | Drug | Intravenous injection dosed once every three weeks |
|
| To evaluate preliminary antitumor activity of XL147 in combination with carboplatin and paclitaxel | Assessed at periodic visits |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| Investigational Site Number | Houston | Texas | 77030-4009 | United States |
| Investigational Site Number | Madison | Wisconsin | 53792-6164 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C581157 | XL147 |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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