Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Every 3 Weeks in Subjects With Advanced Malignancies
1 other identifier
interventional
81
0 countries
N/A
Brief Summary
Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2006
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 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
February 22, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2010
CompletedOctober 23, 2017
October 1, 2017
3.4 years
March 26, 2009
October 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity
End of trial
In Part 1 and Part 2, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
Cycle 1
Secondary Outcomes (1)
In Part 3, area under the plasma concentration versus time curve and maximum concentration of SCH 727965 administered as a 2 hour intravenous infusion with or without aprepitant in participants with advanced malignancies.
Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2
Study Arms (5)
2 Hour SCH 727965 infusion
EXPERIMENTALParticipants treated with 2 hour SCH 727965 IV infusion
8 Hour SCH 727965 infusion
EXPERIMENTALParticipants treated with 8 hour SCH 727965 IV infusion.
24 Hour SCH 727965 infusion
EXPERIMENTALParticipants treated with 24 hour SCH 727965 IV infusion.
2 Hour SCH 727965 infusions plus aprepitant in Cycle 1
EXPERIMENTALParticipants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
2 Hour SCH 727965 infusion plus aprepitant in Cycle 2
EXPERIMENTALParticipants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.
Interventions
SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
Oral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3.
Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
Oral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4.
Eligibility Criteria
You may qualify if:
- Age \>=18 years, either sex, any race.
- Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
- There must be no known standard therapy, or disease must be refractory to standard therapy.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
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)
Zhang D, Mita M, Shapiro GI, Poon J, Small K, Tzontcheva A, Kantesaria B, Zhu Y, Bannerji R, Statkevich P. Effect of aprepitant on the pharmacokinetics of the cyclin-dependent kinase inhibitor dinaciclib in patients with advanced malignancies. Cancer Chemother Pharmacol. 2012 Dec;70(6):891-8. doi: 10.1007/s00280-012-1967-y. Epub 2012 Oct 9.
PMID: 23053255RESULTMita MM, Mita AC, Moseley JL, Poon J, Small KA, Jou YM, Kirschmeier P, Zhang D, Zhu Y, Statkevich P, Sankhala KK, Sarantopoulos J, Cleary JM, Chirieac LR, Rodig SJ, Bannerji R, Shapiro GI. Phase 1 safety, pharmacokinetic and pharmacodynamic study of the cyclin-dependent kinase inhibitor dinaciclib administered every three weeks in patients with advanced malignancies. Br J Cancer. 2017 Oct 24;117(9):1258-1268. doi: 10.1038/bjc.2017.288. Epub 2017 Aug 31.
PMID: 28859059RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
October 11, 2006
Primary Completion
February 22, 2010
Study Completion
February 22, 2010
Last Updated
October 23, 2017
Record last verified: 2017-10