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Completed Phase 1 Interventional

First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies

ClinicalTrials.gov ID: NCT01971515

Public ClinicalTrials.gov record NCT01971515. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I, First-in-Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects With Advanced Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.

Study identification

NCT ID
NCT01971515
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
EMD Serono
Industry
Enrollment
101 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 13, 2013 (Actual)
Primary completion
Aug 9, 2018 (Actual)
Completion
Aug 9, 2018 (Actual)
Last update posted
Sep 19, 2018

2013 – 2018

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Cedars Sinai Medical Center Los Angeles California 90048 —
University of California at San Diego, Moores Cancer Center San Diego California 92093 —
Sylvester Comprehensive Cancer Center Miami Florida 33136 —
Metairie Oncology Metairie Louisiana 70006 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Henry Ford Hospital Detroit Michigan 48202 —
Washington University School of Medicine St Louis Missouri 63110 —
Mount Sinai New York New York 10029 —
Medical University of South Carolina Charleston South Carolina 29425 —
Mary Crowley Cancer Research Center Dallas Texas 75251 —
MD Anderson Cancer Center Houston Texas 77030 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 —
Fletcher Allen Health Care, Inc. Burlington Vermont 05401 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01971515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 19, 2018 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01971515 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →