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Safety Study of XL147 (SAR245408) in Combination With Erlotinib in Adults With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00692640•Sanofi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects accrue to one of two phases:
•* in the Dose Escalation Phase, the subject has a histologically confirmed solid tumor that is metastatic or unresectable and is no longer responding to therapies known to prolong survival or to other standard therapies, or has disease for which no standard therapy exists or for which monotherapy with erlotinib is considered standard therapy.
•* in the Cohort Expansion Phase, the subject has advanced or metastatic NSCLC that is no longer responding to therapies known to prolong survival or to other standard therapies and which:
•1. has been previously or currently treated with erlotinib or gefitinib or
•2. with the agreement of the sponsor, has been previously or is currently treated with other EGFR/VEGFR tyrosine kinase inhibitors
•The subject has measurable or non-measurable lesions by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
•At least 10 unstained slides of tumor tissue, archival or fresh, or paraffin block or a fresh tumor biopsy are identified and designated for central laboratory analysis.
•The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•The subject has adequate organ and marrow function.
•The subject has a fasting plasma glucose ≤ 120 mg/dL at screening.
+4 more criteria

Exclusion Criteria

•The subject has previously been treated with a selective PI3K inhibitor.
•The subject has received:
•* cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (antibodies, immune modulators, cytokines) within 3 weeks or has received nitrosoureas or mitomycin C within 6 weeks before the scheduled first dose of XL147
•* a small-molecule kinase inhibitor (including investigational small molecule kinase inhibitors) excluding small-molecule inhibitors of EGFR or non-cytotoxic hormonal agent within 14 days of the scheduled first dose of XL147
•* other investigational therapy (ie, not specified in exclusion criterion) within 28 days of the first scheduled dose of XL147
•The subject has not recovered from toxicity due to prior therapy to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or less (except alopecia).
•The subject has a diagnosis of uncontrolled diabetes mellitus.
•The subject is currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day, heparin, and low-molecular weight heparins are permitted).
•The subject is taking oral corticosteroids chronically.
•The subject has prothrombin time/International Normalized Ratio and/or partial thromboplastin time test results at screening that are above 1.3x the laboratory upper limit of normal.
+8 more criteria

Locations (1)

Investigational Site Number 1214

Nashville, Tennessee, United States

Key Dates

Start Date

May 1, 2008

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

March 23, 2012

Enrollment

ACTUAL participants

Conditions

CancerNon-small Cell Lung Cancer

Interventions

XL147 (SAR245408)

DRUG

Erlotinib

DRUG

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NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma