A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia
NCT01701375
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- 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.
- • 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
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia | |||
Official Title ICMJE | 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 | |||
Brief Summary | 1.1 Primary Objectives
1.2 Secondary Objectives:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: PD 0332991
? PD 0332991 will be given orally days 1,2,3 | |||
Study Arms ICMJE | Experimental: Arm 1
Intervention: Drug: PD 0332991 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 2 | |||
Original Estimated Enrollment ICMJE | 42 | |||
Actual Study Completion Date ICMJE | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01701375 | |||
Other Study ID Numbers ICMJE | J1275 NA_00076003 ( Other Identifier: JHMIRB ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Verification Date | August 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |