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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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143635
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 19, 2014
First Posted Date  ICMJE May 21, 2014
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE July 7, 2014
Actual Primary Completion Date June 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Incidence of dose limiting toxicities (DLTs) [ Time Frame: up to 28 days ]
DLTs in the first cycle of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • 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: up to 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid and Hematological TP53wt Tumors
Intervention  ICMJE
  • Drug: HDM201
  • Drug: ancillary treatment
Study Arms  ICMJE
  • Experimental: Arm A
    Interventions:
    • Drug: HDM201
    • Drug: ancillary treatment
  • Experimental: Arm B
    Intervention: Drug: HDM201
  • Experimental: Arm C
    Intervention: Drug: HDM201
  • Experimental: Arm D
    Intervention: Drug: HDM201
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2018)
208
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2014)
126
Actual Study Completion Date  ICMJE June 9, 2020
Actual Primary Completion Date June 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Japan,   Netherlands,   Singapore,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02143635
Other Study ID Numbers  ICMJE CHDM201X2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP