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Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

Primary Purpose

Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SCH 727965
SCH 727965
SCH 727965
SCH 727965
Aprepitant
Ondansetron
Dexamethasone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    2 Hour SCH 727965 infusion

    8 Hour SCH 727965 infusion

    24 Hour SCH 727965 infusion

    2 Hour SCH 727965 infusions plus aprepitant in Cycle 1

    2 Hour SCH 727965 infusion plus aprepitant in Cycle 2

    Arm Description

    Participants treated with 2 hour SCH 727965 IV infusion

    Participants treated with 8 hour SCH 727965 IV infusion.

    Participants treated with 24 hour SCH 727965 IV infusion.

    Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.

    Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity
    In Part 1 and Part 2, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 26, 2009
    Last Updated
    October 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00871910
    Brief Title
    Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 11, 2006 (Actual)
    Primary Completion Date
    February 22, 2010 (Actual)
    Study Completion Date
    February 22, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Solid Tumors, Lymphoma, Non-Hodgkin, Multiple Myeloma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2 Hour SCH 727965 infusion
    Arm Type
    Experimental
    Arm Description
    Participants treated with 2 hour SCH 727965 IV infusion
    Arm Title
    8 Hour SCH 727965 infusion
    Arm Type
    Experimental
    Arm Description
    Participants treated with 8 hour SCH 727965 IV infusion.
    Arm Title
    24 Hour SCH 727965 infusion
    Arm Type
    Experimental
    Arm Description
    Participants treated with 24 hour SCH 727965 IV infusion.
    Arm Title
    2 Hour SCH 727965 infusions plus aprepitant in Cycle 1
    Arm Type
    Experimental
    Arm Description
    Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
    Arm Title
    2 Hour SCH 727965 infusion plus aprepitant in Cycle 2
    Arm Type
    Experimental
    Arm Description
    Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.
    Intervention Type
    Drug
    Intervention Name(s)
    SCH 727965
    Intervention Description
    SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
    Intervention Type
    Drug
    Intervention Name(s)
    SCH 727965
    Intervention Description
    SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts
    Intervention Type
    Drug
    Intervention Name(s)
    SCH 727965
    Intervention Description
    SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts
    Intervention Type
    Drug
    Intervention Name(s)
    SCH 727965
    Intervention Description
    SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Aprepitant
    Other Intervention Name(s)
    Emend
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ondansetron
    Other Intervention Name(s)
    Zofran
    Intervention Description
    Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    Decadron
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity
    Time Frame
    End of trial
    Title
    In Part 1 and Part 2, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes.
    Time Frame
    Cycle 1
    Secondary Outcome Measure Information:
    Title
    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.
    Time Frame
    Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23053255
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28859059
    Citation
    Mita 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.
    Results Reference
    result

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    Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

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