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Completed

NCT Number: NCT00871910

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

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.

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Key information

Conditions

Solid Tumors Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCH 727965

Drug

SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)

Aprepitant

Drug

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.

Other names: Emend

ondansetron

Drug

Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.

Other names: Zofran

Dexamethasone

Drug

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.

Other names: Decadron

Primary outcomes

  1. Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity

    Time frame: End of trial

  2. 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 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.

    Time frame: Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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