Skip to main content
OpenTrials
Completed

NCT Number: NCT02143635

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid and Hematological TP53wt Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDM201

Drug

ancillary treatment

Drug

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: up to 28 days

    DLTs in the first cycle of treatment.

Secondary outcomes

  1. Number of patients with adverse events (AEs)

    Time frame: For the duration of treatment, an average of 16 weeks

    Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent.

  2. Pharmacokinetics (PK) parameters of HDM201

    Time frame: Up to 42 days

  3. Changes from baseline of Pharmacodynamics markers

    Time frame: Baseline, up to 28 days

  4. Tumor response

    Time frame: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment

    end of treatment = 1 year

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
May 21, 2014
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.