Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
NCT ID: NCT02143635
Last Updated: 2021-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
208 participants
INTERVENTIONAL
2014-07-07
2020-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
HDM201
ancillary treatment
Arm B
HDM201
Arm C
HDM201
Arm D
HDM201
Interventions
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HDM201
ancillary treatment
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Related Links
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Other Identifiers
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CHDM201X2101
Identifier Type: -
Identifier Source: org_study_id
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