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

This study is currently recruiting participants.
Verified September 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02143635
First Posted: May 21, 2014
Last Update Posted: September 14, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

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

Study Type: Interventional
Study Design: 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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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


Secondary Outcome Measures:
  • 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.

  • Pharmacokinetics (PK) parameters of HDM201 [ Time Frame: Up to 42 days ]
  • Changes from baseline of Pharmacodynamics markers [ Time Frame: 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


Estimated Enrollment: 225
Actual Study Start Date: July 7, 2014
Estimated Study Completion Date: July 14, 2018
Primary Completion Date: June 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: HDM201 Drug: ancillary treatment
Experimental: Arm B Drug: HDM201
Experimental: Arm C Drug: HDM201
Experimental: Arm D Drug: HDM201

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02143635


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, Massachusetts
Dana Farber Cancer Institute SC-6 Recruiting
Boston, Massachusetts, United States, 02215
Contact: Shannon Milillo    617-632-4912    shannon_milillo@dfci.harvard.edu   
Principal Investigator: Daniel J. DeAngelo         
United States, New York
Memorial Sloan Kettering Cancer Center Onc. Dep Recruiting
New York, New York, United States, 10065
Contact: Gerry O'Neill    646-888-4426    oneillg@mskcc.org   
Principal Investigator: David Hyman         
France
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Germany
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Würzburg, Germany, 97080
Japan
Novartis Investigative Site Recruiting
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site Recruiting
Utrecht, Netherlands, 3584CX
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Taiwan
Novartis Investigative Site Recruiting
Taipei, Taiwan ROC, Taiwan, 10041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02143635     History of Changes
Other Study ID Numbers: CHDM201X2101
First Submitted: May 19, 2014
First Posted: May 21, 2014
Last Update Posted: September 14, 2017
Last Verified: September 2017
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)