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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02143635
Collaborator
(none)
208
Enrollment
15
Locations
4
Arms
71.1
Actual Duration (Months)
13.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 7, 2014
Actual Primary Completion Date :
Jun 20, 2017
Actual Study Completion Date :
Jun 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: HDM201

Drug: ancillary treatment
Experimental: Arm B

Drug: HDM201
Experimental: Arm C

Drug: HDM201
Experimental: Arm D

Drug: HDM201

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose limiting toxicities (DLTs) [up to 28 days]

    DLTs in the first cycle of treatment.

Secondary Outcome Measures

  1. Number of patients with adverse events (AEs) [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 [Up to 42 days]

  3. Changes from baseline of Pharmacodynamics markers [Baseline, up to 28 days]

  4. Tumor response [Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment]

    end of treatment = 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dana Farber Cancer Institute SC-6 Boston Massachusetts United States 02215
2 Memorial Sloan Kettering Onc. Dep New York New York United States 10017
3 Novartis Investigative Site Lyon Cedex France 69373
4 Novartis Investigative Site Paris France 75010
5 Novartis Investigative Site Essen Germany 45147
6 Novartis Investigative Site Frankfurt Germany 60590
7 Novartis Investigative Site Wuerzburg Germany 97080
8 Novartis Investigative Site Kobe-shi Hyogo Japan 650-0017
9 Novartis Investigative Site Chuo ku Tokyo Japan 104 0045
10 Novartis Investigative Site Amsterdam Netherlands 1066 CX
11 Novartis Investigative Site Utrecht Netherlands 3584CX
12 Novartis Investigative Site Singapore Singapore 169610
13 Novartis Investigative Site Barcelona Catalunya Spain 08035
14 Novartis Investigative Site Barcelona Catalunya Spain 08036
15 Novartis Investigative Site Taipei Taiwan ROC Taiwan 10041

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02143635
Other Study ID Numbers:
  • CHDM201X2101
First Posted:
May 21, 2014
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of May 21, 2021