Description:
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected
advanced tumors characterized by wild-type TP53.
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
Drug | Synonyms | Arms |
---|
HDM201 | | Arm A |
ancillary treatment | | Arm 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
Name | Type | Description | Interventions |
---|
Arm A | Experimental | | - HDM201
- ancillary treatment
|
Arm B | Experimental | | |
Arm C | Experimental | | |
Arm D | Experimental | | |
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: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- HDM201,TP53wt, p53, MDM2, HDM2, advanced tumors, BLRM (Bayesian logistic regression model)
Last Updated
May 21, 2021