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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
  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
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ 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


Estimated Enrollment: 126
Study Start Date: July 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: HDM201
Experimental: Arm B Drug: HDM201

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02143635

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Onc. Dep Not yet recruiting
New York, New York, United States, 10021
Contact: Nana Akom    646-888-4426    akomn@mskcc.org   
Principal Investigator: David Hyman         
France
Novartis Investigative Site Not yet recruiting
Lyon Cedex, France, 69373
Germany
Novartis Investigative Site Not yet recruiting
Essen, Germany, 45147
Novartis Investigative Site Not yet recruiting
Würzburg, Germany, 97080
Japan
Novartis Investigative Site Not yet recruiting
Chuo-ku, Tokyo, Japan
Netherlands
Novartis Investigative Site Not yet recruiting
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site Not yet recruiting
Utrecht, Netherlands, 3584CX
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Not yet recruiting
Barcelona, Catalunya, Spain, 08035
Taiwan
Novartis Investigative Site Not yet recruiting
Taipei, Taiwan ROC, Taiwan, 100
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02143635     History of Changes
Other Study ID Numbers: CHDM201X2101
Study First Received: May 19, 2014
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
France: National Agency for the Safety of Medicine and Health Products
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
The Netherlands: Medicines Evaluation Board (MEB)
Spain: Medicines and Health Products Agency (AEMPS)
Singapore: Health Sciences Authority (HSA)
Taiwan: Center for Drug Evaluation
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

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

Additional relevant MeSH terms:
Li-Fraumeni Syndrome
Neoplasms
DNA Repair-Deficiency Disorders
Genetic Diseases, Inborn
Metabolic Diseases
Neoplastic Syndromes, Hereditary

ClinicalTrials.gov processed this record on November 20, 2014