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Completed Phase 1 Interventional Results available

A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas

ClinicalTrials.gov ID: NCT01877382

Public ClinicalTrials.gov record NCT01877382. 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 Nov 11, 2026, 9:51 AM EST

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Official title

A Phase 1 Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas

Brief summary

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

This will be a Phase 1, open-label study of milademetan to assess its safety and tolerability, identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK)/ pharmacodynamic (PDy) properties in participants with advanced solid tumors or lymphomas. Approximately 5 US sites are planned for Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The same sites are planned to participate for both parts.

Study identification

NCT ID
NCT01877382
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
107 participants

Conditions and interventions

Interventions

Drug

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
Jul 11, 2013 (Actual)
Primary completion
Oct 8, 2020 (Actual)
Completion
Dec 3, 2020 (Actual)
Last update posted
Mar 27, 2025

2013 – 2020

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Karmanos Cancer Institute Detroit Michigan 48201 —
Columbia University College of Physicians and Surgeons New York New York 10032 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Tennessee Oncology Nashville Tennessee 37203 —
UT MD Anderson Cancer Center Houston Texas 77030 —

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 NCT01877382, 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 Mar 27, 2025 · Synced Nov 11, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01877382 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →