SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)

Leukemia, Myeloid, Acute Clinical Trial

Official title:

A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00798213
• Other study ID #: P04717
• Status: Terminated
• Phase: Phase 2
• First received: November 25, 2008
• Last updated: February 3, 2015
• Start date: January 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoblastic Leukemia, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• SCH 727965
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
• Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 leuk — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Primary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.		Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).	No
Secondary	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).	No