Clinical Trials /

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

NCT02143635

Description:

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

Related Conditions:
  • Leukemia
  • Lymphoma
  • Malignant Solid Tumor
  • Multiple Myeloma
  • Myelodysplastic Syndromes
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CHDM201X2101
  • NCT ID: NCT02143635

Conditions

  • Advanced Solid and Hematological TP53wt Tumors

Interventions

DrugSynonymsArms
HDM201Arm A
ancillary treatmentArm A

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimental
  • HDM201
  • ancillary treatment
Arm BExperimental
  • HDM201
Arm CExperimental
  • HDM201
Arm DExperimental
  • HDM201

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose limiting toxicities (DLTs)
Time Frame:up to 28 days
Safety Issue:
Description:DLTs in the first cycle of treatment.

Secondary Outcome Measures

Measure:Number of patients with adverse events (AEs)
Time Frame:For the duration of treatment, an average of 16 weeks
Safety Issue:
Description:Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent.
Measure:Pharmacokinetics (PK) parameters of HDM201
Time Frame:Up to 42 days
Safety Issue:
Description:
Measure:Changes from baseline of Pharmacodynamics markers
Time Frame:Baseline, up to 28 days
Safety Issue:
Description:
Measure:Tumor response
Time Frame:Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment
Safety Issue:
Description:end of treatment = 1 year

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)

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