Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gelatin capsules supplied in 25-mg and 100-mg strengths; daily dosing for 21 days/7 days off

XL147 (SAR245408)

Tablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing

Erlotinib

Clinical Sciences & Operations

The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with erlotinib (Tarceva®) in subjects 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. 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.

Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors

A Phase 1 Dose-Escalation Study of XL147 (SAR245408) in Combination With Erlotinib in Subjects With Solid Tumors

Sanofi

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Gelatin capsules supplied in 25-mg and 100-mg dosage strengths

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

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.

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

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

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

XL147 in combination with trastuzumab and paclitaxel

administered orally once daily as tablet(s)

trastuzumab

paclitaxel

Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with trastuzumab (Herceptin) and in combination with trastuzumab and paclitaxel. After the MTD is established for each combination (Phase 2), subjects will be enrolled to evaluate the preliminary efficacy and safety of these combinations in metastatic HER2 positive breast cancer. Both trastuzumab and paclitaxel are used in the treatment of metastatic breast cancer (MBC), but patients can develop resistance.

The link between PI3K mutations and trastuzumab resistance has been seen in breast cancer patients. This suggests that inhibitors of the PI3K/PTEN pathway may have the potential to restore sensitivity to trastuzumab. Similarly, introduction of activated mutant forms of PI3K has been shown to transform and confer paclitaxel resistance to immortalized breast epithelial cells. XL147 is a potent and selective inhibitor of PI3K and inhibits phosphorylation of multiple downstream components of PI3K/PTEN signaling. Therefore, XL147 may have utility in the treatment of trastuzumab resistant/refractory and HER2-positive MBC when administered in combination with trastuzumab alone or with trastuzumab and paclitaxel.

Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen

A Phase 1/2 Study of XL147 (SAR245408) Administered in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen

Symptoms and General Pathology

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Twice-daily dosing (every 12 hours) XL765

XL765 (SAR245409)

Supplied as 100-mg, 150-mg and/or 200-mg tablets

The purpose of this study is to measure what effect the study drug XL765 (SAR245409) or the study drug XL147 (SAR245408) has on tumor tissue in subjects with recurrent glioblastoma (GB) who are candidates for surgical resection. XL765 (SAR245409) and XL147 (SAR245408), the two investigational agents examined in this study, XL147 (SAR245408) is a potent inhibitor of PI3 Kinase (PI3K) and XL765 (SAR245409) is a dual PI3K and mTOR inhibitor. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.

Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection

An Exploratory Pharmacodynamic Study of XL765 and XL147 Administered as Single Agents to Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors	NCT00692640	Cancer Non-small Cell ...	XL147 (SAR24540... Erlotinib	18 Years -	Sanofi
Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma	NCT00486135	Cancer Lymphoma	XL147 (SAR24540... XL147 (SAR24540...	18 Years -	Sanofi
Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma	NCT00486135	Cancer Lymphoma	XL147 (SAR24540... XL147 (SAR24540...	18 Years -	Sanofi
Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen	NCT01042925	Breast Cancer Breast Neoplasm...	XL147 (SAR24540... trastuzumab paclitaxel	18 Years -	Sanofi
Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors	NCT00692640	Cancer Non-small Cell ...	XL147 (SAR24540... Erlotinib	18 Years -	Sanofi
Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection	NCT01240460	Glioblastoma Astrocytoma, Gr...	XL765 (SAR24540... XL147 (SAR24540...	18 Years -	Sanofi
Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen	NCT01042925	Breast Cancer Breast Neoplasm...	XL147 (SAR24540... trastuzumab paclitaxel	18 Years -	Sanofi
Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors	NCT00692640	Cancer Non-small Cell ...	XL147 (SAR24540... Erlotinib	18 Years -	Sanofi
Study of XL147 (SAR245408) in Combination With Trastuzumab or Paclitaxel and Trastuzumab in Subjects With Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-based Regimen	NCT01042925	Breast Cancer Breast Neoplasm...	XL147 (SAR24540... trastuzumab paclitaxel	18 Years -	Sanofi

Spots Global Cancer Trial Database for xl147 (sar245408)