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NCT01207323 · ClinicalTrials.gov registry record · Phase 1

A Study of the Safety and Pharmacokinetics (PK) of MEHD7945A in Participants With Locally Advanced or Metastatic Epithelial Tumors

A Phase 1 study, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT01207323 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 66 participants.

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The verdict

NCT01207323, a Phase 1 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

This is a Phase I, multicenter, open-label study of MEHD7945A in participants with incurable, locally advanced, or metastatic epithelial malignancies that have progressed despite standard therapy or for which no standard therapy exists. The study will be conducted in two stages: a dose escalation stage and an expansion stage. The dose-escalation stage is designed to evaluate the safety, tolerability, and PK of MEHD7945A administered (at five dose levels from 1 to 30 milligrams per kilogram \[mg/kg\]) every 2 week (Q2W). An expansion stage will be initiated after establishment of maximum tolerated dose (MTD) in dose escalation stage. Participants with refractory or recurrent metastatic colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and pancreatic cancer will be enrolled in an expansion stage to better characterize the safety, tolerability, PK and preliminary assessment of the anti-tumor activity of MEHD7945A.

Interventions

  • DRUG MEHD7945A

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2010-11-09
Est. Completion 2018-04-23
Phase Phase 1

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01207323

The ClinicalTrials.gov registry entry for NCT01207323 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which MEHD7945A is the first listed.

NCT01207323 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01207323 about?

NCT01207323 is a clinical study titled "A Study of the Safety and Pharmacokinetics (PK) of MEHD7945A in Participants With Locally Advanced or Metastatic Epithelial Tumors". This is a Phase I, multicenter, open-label study of MEHD7945A in participants with incurable, locally advanced, or metastatic epithelial malignancies that have progressed despite standard therapy or for which no standard therapy exists. The study will be conducted in two stages: a dose escalation st...

What is the current status of trial NCT01207323?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2010-11-09. Estimated completion is 2018-04-23.

What interventions are being tested in trial NCT01207323?

The interventions under investigation include: MEHD7945A (DRUG).

Who is sponsoring clinical trial NCT01207323?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.