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Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630AM6)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00871910
First received: March 26, 2009
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Lymphoma, Non-Hodgkin
Multiple Myeloma
 Drug: SCH 727965
Drug: Aprepitant
Drug: Ondansetron
Drug: Dexamethasone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity [ Time Frame: End of trial ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: Cycle 1 Days 1 and 2, and Cycle 2 Days 1 and 2 ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: October 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Hour SCH 727965 infusion
Participants treated with 2 hour SCH 727965 IV infusion
 Drug: SCH 727965
SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
Experimental: 8 Hour SCH 727965 infusion
Participants treated with 8 hour SCH 727965 IV infusion.
 Drug: SCH 727965
SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts
Experimental: 24 Hour SCH 727965 infusion
Participants treated with 24 hour SCH 727965 IV infusion.
 Drug: SCH 727965
SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts
Experimental: 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1
Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only.
 Drug: SCH 727965
SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle
Drug: Aprepitant
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 Name: Emend
Drug: Ondansetron
Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
Other Name: Zofran
Drug: Dexamethasone
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 Name: Decadron
Experimental: 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2
Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only.
 Drug: SCH 727965
SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle
Drug: Aprepitant
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 Name: Emend
Drug: Ondansetron
Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
Other Name: Zofran
Drug: Dexamethasone
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 Name: Decadron

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00871910     History of Changes
Other Study ID Numbers: P04630
Study First Received: March 26, 2009
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013