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

Completed · Phase 1

Conditions studied: Advanced Solid and Hematological TP53wt Tumors

In brief

To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

Key facts

Study ID

NCT02143635

Run by

Novartis Pharmaceuticals

People needed

208

Starts

2014-07-07

Expected to finish

2020-06-09

Last updated by the study team

2021-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute SC-6 — Boston, Massachusetts, United States
• Memorial Sloan Kettering Onc. Dep — New York, New York, United States
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Kobe, Hyōgo, Japan
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Utrecht, Netherlands
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Taipei, Taiwan ROC, Taiwan

Full record on ClinicalTrials.gov

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