Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
Conditions
Advanced Solid and Hematological TP53wt Tumors
Conditions: official terms
Li-Fraumeni Syndrome
Conditions: Keywords
HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HDM201
Type: Drug
Overall Status
Recruiting
Summary
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Lurie Children's Hospital of Chicago Research Office
Chicago, Illinois, United States
Status: Not yet recruiting
Contact: Ashlee Drawz - 312-926-4299 - a-stephens@northwestern.edu
Dana Farber Cancer Institute SC-6
Boston, Massachusetts, United States
Status: Not yet recruiting
Contact: Shannon Milillo - 617-632-4912 - shannon_milillo@dfci.harvard.edu
Memorial Sloan Kettering Cancer Center Onc. Dep
New York, New York, United States
Status: Recruiting
Contact: Juho Whang - 646-888-4426 - whangj@mskcc.org
Novartis Investigative Site
Lyon Cedex, France
Status: Recruiting
Novartis Investigative Site
Essen, Germany
Status: Recruiting
Novartis Investigative Site
Frankfurt, Germany
Status: Not yet recruiting
Novartis Investigative Site
Würzburg, Germany
Status: Recruiting
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Status: Recruiting
Novartis Investigative Site
Amsterdam, Netherlands
Status: Recruiting
Novartis Investigative Site
Utrecht, Netherlands
Status: Recruiting
Novartis Investigative Site
Singapore, Singapore
Status: Recruiting
Novartis Investigative Site
Barcelona, Catalunya, Spain
Status: Recruiting
Novartis Investigative Site
Taipei, Taiwan ROC, Taiwan
Status: Recruiting
Start Date
July 2014
Completion Date
September 2016
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page