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

NCT02143635 | Completed Phase 1 FDA Drug

• 1 other identifier: CHDM201X2101
• Study Type: interventional
• Target: 208
• Locations: 8 countries
• Sites: 15

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.

Conditions

Advanced Solid and Hematological TP53wt Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities (DLTs)

  DLTs in the first cycle of treatment.

  up to 28 days

Secondary Outcomes (4)

• Number of patients with adverse events (AEs)

  For the duration of treatment, an average of 16 weeks

• Pharmacokinetics (PK) parameters of HDM201

  Up to 42 days

• Changes from baseline of Pharmacodynamics markers

  Baseline, up to 28 days

• Tumor response

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

Study Arms (4)

Arm A

EXPERIMENTAL

Drug: HDM201; Drug: ancillary treatment

Arm B

EXPERIMENTAL

Drug: HDM201

Arm C

EXPERIMENTAL

Drug: HDM201

Arm D

EXPERIMENTAL

Drug: HDM201

Interventions

HDM201 DRUG

Arm A; Arm B; Arm C; Arm D

ancillary treatment DRUG

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Dana Farber Cancer Institute SC-6

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Onc. Dep

New York, New York, 10017, United States

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Paris, 75010, France

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 104 0045, Japan

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

Utrecht, 3584CX, Netherlands

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Taipei, Taiwan ROC, 10041, Taiwan

Location

Related Links

• Study Results

MeSH Terms

Interventions

siremadlin

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: July 7, 2014
• Primary Completion: June 20, 2017
• Study Completion: June 9, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); FR (2); NL (2); ES (2); DE (3); SG (1); US (2); TW (1)