SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
1 other identifier
interventional
29
0 countries
N/A
Brief Summary
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2009
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 4, 2015
February 1, 2015
1.2 years
November 25, 2008
February 3, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
Secondary Outcomes (4)
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
Study Arms (4)
Participants with AML randomized to SCH 727965
EXPERIMENTALParticipants with AML randomized to gemtuzumab ozogamicin
ACTIVE COMPARATORAML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin
EXPERIMENTALParticipants with ALL treated with SCH 727965
EXPERIMENTALInterventions
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
Eligibility Criteria
You may qualify if:
- For participants with AML:
- Age \>=60 years, either sex, any race.
- Diagnosis of CD33-positive AML by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
- Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
- For participants with ALL:
- Age \>=18 years, either sex, any race.
- Diagnosis of ALL by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to \<=30 x 10\^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.
You may not qualify if:
- Known central nervous system leukemia.
- Previous hematopoietic stem cell transplantation.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For AML, previous treatment with gemtuzumab ozogamicin.
- Known HIV infection.
- Known active hepatitis B or C.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gojo I, Sadowska M, Walker A, Feldman EJ, Iyer SP, Baer MR, Sausville EA, Lapidus RG, Zhang D, Zhu Y, Jou YM, Poon J, Small K, Bannerji R. Clinical and laboratory studies of the novel cyclin-dependent kinase inhibitor dinaciclib (SCH 727965) in acute leukemias. Cancer Chemother Pharmacol. 2013 Oct;72(4):897-908. doi: 10.1007/s00280-013-2249-z. Epub 2013 Aug 15.
PMID: 23949430RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
January 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 4, 2015
Record last verified: 2015-02