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NCT01701375 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01701375: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01701375 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701375, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
1.1 Primary Objectives * To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease * To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts * To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone * To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS 1.2 Secondary Objectives: * To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo * To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity
Primary Outcome
The number of participants experiencing 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
Interventions
- DRUG PD 0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
Why NCT01701375 stopped before completion
NCT01701375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which PD 0332991 is the first listed.
NCT01701375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701375 about?
NCT01701375 is a clinical study titled "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". 1.1 Primary Objectives * To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including p...
What is the current status of trial NCT01701375?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2012-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01701375?
The interventions under investigation include: PD 0332991 (DRUG).
Who is sponsoring clinical trial NCT01701375?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701375's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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