Clinical Trials

Alvocidib in AML: Phase 2 (Zella 201)

Zella 201: Alvocidib Biomarker-driven Phase 2 AML Trial

A Biomarker-Driven Trial 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

alvocidib biomarker - driven phase 2 AML study

Key Inclusion Criteria

  • ≥18 and ≤65 years of age
  • ECOG PS ≤2
  • 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) as evaluated 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

See ClinicalTrials.gov for comprehensive eligibility criteria.

Study Locations

For sites in the US/Canada and Europe that are actively recruiting, visit clinicaltrials.gov (NCT02520011).

About Alvocidib

Alvocidib is an investigational, intravenously administered, small molecule cyclin-dependent kinase 9 (CDK9) inhibitor not yet approved by the US FDA or any other health authorities.

Learn more about Zella 201, the biomarker-driven alvocidib trial, at clinicaltrials.gov (NCT02520011)

*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; ECOG PS=Eastern Cooperative Oncology Group Performance Status.

Alvocidib in AML: Phase 1 (Zella 101)

Zella 101: A Trial of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

a chart showing the study of alvocidib and cytarabine/daunorubicin (7+3) in patients with newly diagnosed AML

Primary outcome measures:

  • Maximum tolerated dose and dose-limiting toxicities

Secondary outcome measures:

  • Antileukemic activity of alvocidib plus 7+3
  • Correlation between benefit from alvocidib and sequential 7+3 therapy and evaluation of MCL-1 dependency and other potential biomarkers
  • Recommended phase 2 dose of alvocidib in combination with 7+3

Key Inclusion Criteria

  • ≥18 and ≤65 years of age
  • ECOG PS ≤2
  • 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

See ClinicalTrials.gov for comprehensive eligibility criteria.

Study Locations

For sites in the US/Canada and Europe that are actively recruiting, visit clinicaltrials.gov (NCT03298984).

About Alvocidib

Alvocidib is an investigational, intravenously administered, small molecule cyclin-dependent kinase 9 (CDK9) inhibitor not yet approved by the US FDA or any other health authorities.

Learn more about Zella 101, the phase 1 trial of alvocidib in newly diagnosed AML, at clinicaltrials.gov (NCT03298984)

IV=intravenous; MCL-1=myeloid cell leukemia 1; ECOG PS=Eastern Cooperative Oncology Group Performance Status.

TP-0903 in Advanced Solid Tumors: Phase 1

Currently recruiting

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

Study Design

  • Open-label, dose-escalation study
  • Phase 1a: Once daily dose of TP-0903 by oral administration on days 1-21 of each 28-day cycle
  • Phase 1b: Upon confirmation of maximum tolerated dose (MTD), additional cohorts will receive oral daily doses of a flat dose of TP-0903 based on the average of the dose administration in the MTD expansion safety cohort on days 1-21 of each 28-day cycle

Key Inclusion Criteria

  • Age ≥ 18 years
  • ECOG PS 0 or 1
  • Life expectancy ≥ 3 months
  • 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

See ClinicalTrials.gov for comprehensive eligibility criteria.

Study Locations

For sites in the US that are actively recruiting, visit www.clinicaltrials.gov (NCT02729298).

About TP-0903

TP-0903 is an investigational AXL receptor tyrosine kinase inhibitor, which is known to be involved in acquiring resistance to chemotherapeutics and developing metastatic capacity in cancer cells. 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 trial of TP-0903 in advanced solid tumors at clinicaltrials.gov (NCT02729298)

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