Trial Outcomes & Findings for 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 (NCT NCT01701375)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

42 days

Results posted on

2013-09-09

Participant Flow

2 subjects were accrued

Participant milestones

Participant milestones
Measure	Arm 1 * PD 0332991 125 was given orally days 1,2,3 * Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6 * Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=2 Participants * PD 0332991 will be given orally days 1,2,3 * Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6 * Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	45.5 years STANDARD_DEVIATION 27 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days

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

Outcome measures

Outcome measures
Measure	Arm 1 n=2 Participants * PD 0332991 will be given orally days 1,2,3 * Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6 * Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.	2 participants

SECONDARY outcome

Timeframe: 42 days

Dose escalation decisions will be based on nonhematologic toxicities in Cycle 1 (28 days) and hematologic toxicities, in the case of an aplastic marrow through Day 56, For cytopenias including ANC \< 500/mm3 or platelets \< 50, 000/mm3 a bone marrow will be performed between days 42 and 49.. Dose limiting toxicity (DLT) will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=2 participants at risk * PD 0332991 will be given orally days 1,2,3 * Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6 * Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
Metabolism and nutrition disorders Hyperbilirubinemia	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders Bone marrow aplasia	50.0% 1/2 • Number of events 1

Other adverse events

Other adverse events
Measure	Arm 1 n=2 participants at risk * PD 0332991 will be given orally days 1,2,3 * Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6 * Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose
Gastrointestinal disorders mucositis	100.0% 2/2 • Number of events 2

Additional Information

Ivana Gojo, MD

Johns Hopkins University

Phone: 410-502-7726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place