Advanced Solid and Hematological TP53wt Tumors Clinical Trial
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
| Verified date | May 2021 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | June 9, 2020 |
| Est. primary completion date | June 20, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Novartis Investigative Site | Lyon Cedex | |
| France | Novartis Investigative Site | Paris | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Wuerzburg | |
| Japan | Novartis Investigative Site | Chuo ku | Tokyo |
| Japan | Novartis Investigative Site | Kobe-shi | Hyogo |
| Netherlands | Novartis Investigative Site | Amsterdam | |
| Netherlands | Novartis Investigative Site | Utrecht | |
| Singapore | Novartis Investigative Site | Singapore | |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Taiwan | Novartis Investigative Site | Taipei | Taiwan ROC |
| United States | Dana Farber Cancer Institute SC-6 | Boston | Massachusetts |
| United States | Memorial Sloan Kettering Onc. Dep | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, France, Germany, Japan, Netherlands, Singapore, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) | DLTs in the first cycle of treatment. | up to 28 days | |
| Secondary | Number of patients with adverse events (AEs) | Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent. | For the duration of treatment, an average of 16 weeks | |
| Secondary | Pharmacokinetics (PK) parameters of HDM201 | Up to 42 days | ||
| Secondary | Changes from baseline of Pharmacodynamics markers | Baseline, up to 28 days | ||
| Secondary | Tumor response | end of treatment = 1 year | Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment |