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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02143635
Recruitment Status : Recruiting
First Posted : May 21, 2014
Last Update Posted : May 1, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Advanced Solid and Hematological TP53wt Tumors Drug: HDM201 Drug: ancillary treatment Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 7, 2014
Actual Primary Completion Date : June 20, 2017
Estimated Study Completion Date : October 17, 2018

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

Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: up to 28 days ]
    DLTs in the first cycle of treatment.

Secondary Outcome Measures :
  1. 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.

  2. Pharmacokinetics (PK) parameters of HDM201 [ Time Frame: Up to 42 days ]
  3. Changes from baseline of Pharmacodynamics markers [ Time Frame: Baseline, up to 28 days ]
  4. Tumor response [ Time Frame: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment ]
    end of treatment = 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02143635

Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: Shannon Milillo    617-632-4912   
Principal Investigator: Daniel J. DeAngelo         
United States, New York
Novartis Investigative Site Recruiting
New York, New York, United States, 10017
Contact: Gerald ONeill    646-888-4426   
Principal Investigator: David Hyman         
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Recruiting
Paris, France, 75010
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Wurzburg, Germany, 97080
Novartis Investigative Site Recruiting
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site Recruiting
Utrecht, Netherlands, 3584CX
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Recruiting
Taipei, Taiwan ROC, Taiwan, 10041
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT02143635     History of Changes
Other Study ID Numbers: CHDM201X2101
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)