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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. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02143635
First received: May 19, 2014
Last updated: July 15, 2014
Last verified: July 2014

May 19, 2014
July 15, 2014
July 2014
September 2016   (final data collection date for primary outcome measure)
Incidence of dose limiting toxicities (DLTs) [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
DLTs in the first cycle of treatment.
Same as current
Complete list of historical versions of study NCT02143635 on ClinicalTrials.gov Archive Site
  • Number of patients with adverse events (AEs) [ Time Frame: For the duration of treatment, an average of 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Changes from baseline of Pharmacodynamics markers [ Time Frame: Baseline, up to 28 days ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment ] [ Designated as safety issue: No ]
    end of treatment = 1 year
  • Number of patients with adverse events (AEs) [ Time Frame: For the duration of treatment, an average of 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Changes from baseline of Pharmacodynamics markers [ Time Frame: Baseline, up to 28 days ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid and Hematological TP53wt Tumors
Drug: HDM201
  • Experimental: Arm A
    Intervention: Drug: HDM201
  • Experimental: Arm B
    Intervention: Drug: HDM201
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
September 2016
September 2016   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   France,   Germany,   Japan,   Netherlands,   Singapore,   Spain,   Taiwan
 
NCT02143635
CHDM201X2101
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2014

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