Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt

May 20, 2021 updated by: Novartis Pharmaceuticals

A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53

To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon Cedex, France, 69373
        • Novartis Investigative Site
      • Paris, France, 75010
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97080
        • Novartis Investigative Site
  • Japan
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
    • Tokyo
      • Chuo ku, Tokyo, Japan, 104 0045
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Novartis Investigative Site
      • Utrecht, Netherlands, 3584CX
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
  • Taiwan
    • Taiwan ROC
      • Taipei, Taiwan ROC, Taiwan, 10041
        • Novartis Investigative Site
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute SC-6
    • New York
      • New York, New York, United States, 10017
        • Memorial Sloan Kettering Onc. Dep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria.
  • Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Prior treatment with compounds with the same mode of action
  • Subjects with significant or uncontrolled cardiovascular disease
  • History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism
  • Previous and concomitant therapy that precludes enrollment, as defined in the protocol
  • Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection
  • Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery
  • Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
  • Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
Drug: HDM201
Drug: ancillary treatment
EXPERIMENTAL: Arm B
Drug: HDM201
EXPERIMENTAL: Arm C
Drug: HDM201
EXPERIMENTAL: Arm D
Drug: HDM201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicities (DLTs)
Time Frame: up to 28 days
DLTs in the first cycle of treatment.
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events (AEs)
Time Frame: For the duration of treatment, an average of 16 weeks
Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent.
For the duration of treatment, an average of 16 weeks
Pharmacokinetics (PK) parameters of HDM201
Time Frame: Up to 42 days
Up to 42 days
Changes from baseline of Pharmacodynamics markers
Time Frame: Baseline, up to 28 days
Baseline, up to 28 days
Tumor response
Time Frame: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment
end of treatment = 1 year
Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 7, 2014

Primary Completion (ACTUAL)

June 20, 2017

Study Completion (ACTUAL)

June 9, 2020

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (ESTIMATE)

May 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHDM201X2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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