Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
1 other identifier
interventional
123
0 countries
N/A
Brief Summary
The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2006
Longer than P75 for phase_1
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
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 20, 2015
April 1, 2015
6.2 years
March 26, 2009
April 17, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity.
End of trial
In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
End of trial
Study Arms (3)
Advanced solid tumors
EXPERIMENTALParticipants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts
Non-Hodgkin's lymphoma and multiple myeloma
EXPERIMENTALParticipants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965
B cell chronic lymphocytic leukemia
EXPERIMENTALParticipants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts
Interventions
Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Age \>=18 years, either sex, any race.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- There must be no known standard therapy, or disease must be refractory to standard therapy
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters
- For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
- Participants must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
- Evaluable malignancy must be present by computed tomography or magnetic resonance imaging, obtained within 4 weeks prior to the start of treatment with SCH 727965.
- Subjects with multiple myeloma must have measurable disease defined as:
- Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
- Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:
- serum free light chain ratio greater than 5 times the normal ratio limit; and/or
- measurable soft tissue plasmacytoma greater than 2 cm, by either physical examination and/or applicable radiographs; and/or
- bone marrow involvement greater than 30%.
- For B-cell chronic lymphocytic leukemia (B-CLL):
- Diagnosis of B-CLL according to the National Cancer Institute Working Group (NCI-WG) criteria or a histological diagnosis of small lymphocytic lymphoma.
- +1 more criteria
You may not qualify if:
- Symptomatic brain metastases or primary central nervous system malignancy.
- Previous radiation therapy to \>25% of the total bone marrow.
- Previous treatment with SCH 727965.
- Known HIV infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Flynn J, Jones J, Johnson AJ, Andritsos L, Maddocks K, Jaglowski S, Hessler J, Grever MR, Im E, Zhou H, Zhu Y, Zhang D, Small K, Bannerji R, Byrd JC. Dinaciclib is a novel cyclin-dependent kinase inhibitor with significant clinical activity in relapsed and refractory chronic lymphocytic leukemia. Leukemia. 2015 Jul;29(7):1524-9. doi: 10.1038/leu.2015.31. Epub 2015 Feb 24.
PMID: 25708835BACKGROUNDNemunaitis JJ, Small KA, Kirschmeier P, Zhang D, Zhu Y, Jou YM, Statkevich P, Yao SL, Bannerji R. A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies. J Transl Med. 2013 Oct 16;11:259. doi: 10.1186/1479-5876-11-259.
PMID: 24131779RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
August 1, 2006
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
April 20, 2015
Record last verified: 2015-04