Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt
Phase 1
Completed
- Conditions
- Advanced Solid and Hematological TP53wt Tumors
- Interventions
- Drug: ancillary treatment
- Registration Number
- NCT02143635
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A HDM201 - Arm A ancillary treatment - Arm B HDM201 - Arm C HDM201 - Arm D HDM201 -
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicities (DLTs) up to 28 days DLTs in the first cycle of treatment.
- Secondary Outcome Measures
Name Time Method 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.
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 end of treatment = 1 year
Trial Locations
- Locations (3)
Novartis Investigative Site
🇨🇳Taipei, Taiwan ROC, Taiwan
Dana Farber Cancer Institute SC-6
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Onc. Dep
🇺🇸New York, New York, United States