Clinical Trials

Alvocidib in AML: Phase 2 (TPI-ALV-201)

Alvocidib Biomarker-driven Phase 2 AML Study

Currently recruiting

A Biomarker-Driven Study of Alvocidib, Cytarabine, and Mitoxantrone (ACM) in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With an Exploratory Arm in Adult Patients With Newly Diagnosed High-Risk AML

Study Design

*Patients randomized to CM who exhibit progressive disease or no response after a single cycle of CM, or who have a best response of PR after 2 cycles of CM, may cross over to receive ACM.

Patients who cross over to ACM may receive up to a combined total (CM + ACM) of 4 cycles. High-risk AML is characterized by treatment-related AML, secondary AML defined as AML from preexisting myelodysplastic syndromes or myeloproliferative neoplasms, or adverse-risk cytogenetics according to 2017 European LeukemiaNet Guidelines. MCL-1=myeloid cell leukemia 1; IV=intravenous; CR=complete remission; PR=partial remission.

Key Inclusion Criteria

  • ≤65 years of age
  • Pathologically confirmed diagnosis of AML by World Health Organization criteria, excluding acute promyelocytic leukemia, with a bone marrow of >5% blasts based on histology or flow cytometry
  • In first relapse (within 24 months of CR) or have primary refractory AML (refractory to initial induction therapy using 1 or 2 cycles of intensive anthracycline/cytarabine ± etoposide or cladribine induction), or have newly diagnosed high-risk AML
  • MCL-1 dependency of ≥40% or 30%–39% (for exploratory arm) shown by mitochondrial profiling in bone marrow
  • Not received more than 2 cycles of induction therapy for AML, any previous treatment with alvocidib or any other cyclin-dependent kinase (CDK) inhibitor, a hematopoietic stem cell transplant within the previous 2 months, or >360 mg/m2 equivalents of daunorubicin
  • Cytarabine and mitoxantrone must be an acceptable treatment option

About Alvocidib

Alvocidib is an intravenously administered, investigational, CDK inhibitor with selective activity against CDK9, not approved by the US FDA or any other regulatory authorities.

Learn more about the biomarker-driven alvocidib study at clinicaltrials.gov (NCT02520011)

Alvocidib in AML: Phase 1 (TPI-ALV-101)

A Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Study Design

  • ≥18 and ≤65 years of age
  • Pathologically confirmed diagnosis of AML by World Health Organization (WHO) criteria, excluding acute promyelocytic leukemia and core binding factor AML, with ≥20% bone marrow blasts based on histology or flow cytometry
  • Newly diagnosed and previously untreated
  • Not received >100 mg/m2 equivalents of daunorubicin

About Alvocidib

Alvocidib is an intravenously administered, investigational, CDK inhibitor with selective activity against CDK9, not approved by the US FDA or any other regulatory authorities.

Learn more about the phase 1 study of alvocidib in newly diagnosed AML at clinicaltrials.gov (NCT03298984)

TP-0903 in Advanced Solid Tumors: Phase 1

Currently recruiting

First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors

Study Design

  • Open-label, dose-escalating study
  • Stage 1: Single oral daily doses on days 1-21 of each 28-day cycle. Starting dose is 1.5 mg/m2 with subsequent dose escalation using a modified Fibonacci dose escalation schema
  • Stage 2: Upon confirmation of MTD, 2 additional cohorts of up to 10 patients each (20 additional patients total) will receive single oral daily doses of this dose on days 1-21 of each 28-day cycle

Key Inclusion Criteria

  • Histologically confirmed diagnosis of advanced metastatic or progressive solid tumor
  • Refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition
  • One or more tumors measurable or evaluable as outlined by modified RECIST v1.1

About TP-0903

TP-0903 is an investigational small molecule that, in preclinical models, has been shown to inhibit AXL signaling. TP-0903 is an investigational agent and is not approved by the US FDA or any other regulatory authorities.

Learn more about the phase 1 study of TP-0903 in advanced solid tumors at clinicaltrials.gov (NCT02729298)

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