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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

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ClinicalTrials.gov Identifier: NCT02143635
Recruitment Status : Active, not recruiting
First Posted : May 21, 2014
Last Update Posted : October 2, 2018
Sponsor:
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)
Actual Enrollment : 208 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, Older Adult)
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


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


Locations
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
United States, New York
Novartis Investigative Site
New York, New York, United States, 10017
France
Novartis Investigative Site
Lyon Cedex, France, 69373
Novartis Investigative Site
Paris, France, 75010
Germany
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Wurzburg, Germany, 97080
Japan
Novartis Investigative Site
Kobe-shi, Hyogo, Japan, 650-0017
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0045
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Utrecht, Netherlands, 3584CX
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Taiwan
Novartis Investigative Site
Taipei, Taiwan ROC, Taiwan, 10041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02143635     History of Changes
Other Study ID Numbers: CHDM201X2101
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 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)