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A Phase I and Pharmacodynamic Trial of Timed Sequential Administration of the Cyclin Dependent Kinase 4/6 Inhibitor PD 0332991 Followed by Cytarabine Plus Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasias


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Relapsed Acute Leukemia, Refractory Acute Leukemia, High-Risk Myelodysplasia

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Trial Information

A Phase I and Pharmacodynamic Trial of Timed Sequential Administration of the Cyclin Dependent Kinase 4/6 Inhibitor PD 0332991 Followed by Cytarabine Plus Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasias


Inclusion Criteria:



- Adults age ≥ 18 years

- Multilineage bone marrow failure

- Serum creatinine ≤ 2.0 mg/dl

- Hepatic enzymes (AST, ALT) ≤ 3x upper limit of normal (ULN)

- Bilirubin ≤ 2.0 mg/dl, unless due to Gilbert's disease, hemolysis or leukemic
infiltration

- Left ventricular ejection fraction ≥ 45%

- QTc ≤ 470 msec

- RB expression is required for the action of PD 0332991. Because rb deletions and
mutations are rare in acute leukemias and MDS, screening for RB expression will
not be required before enrollment. Pretreatment biopsies will be stored and
analyzed for RB expression if needed subsequently.

Exclusion Criteria:

- • No more than 5 cytotoxic regimens

- Previous allogeneic or autologous stem cell transplantation permitted

- ≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy

- ≥ 2 week delay from prior biologic therapies including hematopoietic growth
factors and vidaza or decitabine

- If using Hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic,
interferon for count control, must be off therapy for ≥ 48 hours prior to
beginning PD 0332991

- No concomitant use of potent CYP450 3A4 inhibitors (e.g. triazole antifungal
agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days
prior to beginning PD 0332991

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the tolerability and toxicities of the combination.

Outcome Description:

The toxicities of administration of PD 0332991 in combination with cytarabine and mitoxantrone will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome Time Frame:

42 days

Safety Issue:

Yes

Principal Investigator

Judith Karp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J1275

NCT ID:

NCT01701375

Start Date:

September 2012

Completion Date:

September 2016

Related Keywords:

  • Relapsed Acute Leukemia
  • Refractory Acute Leukemia
  • High-Risk Myelodysplasia
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Acute Disease

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Weill Cornell Medical CenterNew York, New York  10021