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Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00486135•Sanofi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. An expanded cohort will be enrolled; NSCLC subjects enrolled must have a diagnosis of relapsed or refractory NSCLC (Stage IIIB or IV) and have received at least two prior regimens including one platinum-based chemotherapy regimen.
•2. The subject has a histologically confirmed diagnosis of lymphoma which is relapsed or refractory to standard therapy.
•3. For subjects with solid tumors, the subject has disease that is assessable by tumor marker, physical, or radiologic means. There are separate criteria that apply to subjects with lymphoma.
•4. Subjects with indolent lymphoma must have documented disease status within 12 months prior to study entry.
•5. The subject is ≥18 years old.
•6. The subject's weight is ≥40 kg.
•7. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
•8. The subject has adequate organ and marrow function, and a fasting plasma glucose (FPG) \<160 mg/dL and HbA1c of \<8% at screening.
•9. For the subjects with solid tumors who are to be enrolled into the expanded MTD cohort and tumor genetic alteration subjects:
•1. tumor tissue amenable to serial biopsy, and
+14 more criteria

Exclusion Criteria

•1. The subject has previously been treated with a selective PI3K inhibitor.
•2. Additional restrictions on prior treatment apply.
•3. For lymphoma subjects: known central nervous system involvement, autoimmune disease requiring immunosuppressive therapy, systemic treatment with prednisone \>20mg/day or equivalent within 2 weeks prior to first dose of XL147, autologous stem cell transplantation within 12 weeks prior to first dose, history of any allogeneic transplantation.
•4. The subject has not recovered from toxicity due to all prior therapies.

Locations (4)

Investigational Site Number 1241

Augusta, Georgia, United States

Investigational Site Number 1503

Boston, Massachusetts, United States

Investigational Site Number 1401

Dallas, Texas, United States

Investigational Site Number 3412

Barcelona, Spain

Key Dates

Start Date

June 1, 2007

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

February 1, 2013

Enrollment

118

ACTUAL participants

Conditions

CancerLymphoma

Interventions

XL147 (SAR245408)

DRUG

XL147 (SAR245408)

DRUG

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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: February 1, 2013Data 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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Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or Lymphoma

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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