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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid and Hematological TP53wt Tumors

Treatments: Drug: HDM201; Drug: ancillary treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143635

CHDM201X2101

Details and patient eligibility

About

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

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 4 patient groups

Arm A

Experimental group

Treatment:

Drug: HDM201

Drug: ancillary treatment

Arm B

Experimental group

Treatment:

Drug: HDM201

Arm C

Experimental group

Treatment:

Drug: HDM201

Arm D

Experimental group

Treatment:

Drug: HDM201