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NCT00777699 · ClinicalTrials.gov registry record · Phase 1

Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

A Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target
1
Study location

NCT00777699: Completed Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by Sanofi.

NCT00777699 is a Phase 1 study of Cancer and Non-Small Cell Lung Cancer that has completed, run by Sanofi. The registered enrollment target is 80 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00777699, a Phase 1 study of Cancer and Non-Small Cell Lung Cancer, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of 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.

Interventions

  • DRUG erlotinib
  • DRUG XL765 (SAR245409)

Study Locations (1)

Pennsylvania

  • Investigational Site Number 168983 - Philadelphia

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2008-08
Est. Completion 2011-02
Phase Phase 1
Sanofi

713 total trials

What the finished NCT00777699 record still lists

NCT00777699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which erlotinib is the first listed.

NCT00777699 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00777699 about?

NCT00777699 is a clinical study titled "Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors". The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth ...

What is the current status of trial NCT00777699?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2008-08. Estimated completion is 2011-02.

What conditions does trial NCT00777699 study?

This clinical trial studies the following conditions: Cancer, Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00777699?

The interventions under investigation include: erlotinib (DRUG), XL765 (SAR245409) (DRUG).

Who is sponsoring clinical trial NCT00777699?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00777699 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00777699's enrollment target sits among peer trials

80 349th of 615 higher than 255 of 615 other Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00777699, the US trial registry maintained by the National Library of Medicine. NCT00777699 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.