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Completed

NCT Number: NCT00394966

A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)

This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.

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Key information

Conditions

Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is 18 years of age or older.
  • Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (>=70 mg/m^2).
  • Subject has a Karnofsky performance score of >=60.
  • Subject has a predicted life expectancy of >=3 months.
  • Subject has adequate bone marrow, kidney, and liver function as evidenced by:
  • Absolute neutrophil count >=1,500/mm3 and white blood cell count >=3,000/mm3.
  • Platelet count >=100,000/mm3.
  • Aspartate aminotransferase (AST) <=2.5 x upper limit of normal (ULN) range.
  • Alanine aminotransferase (ALT) <=2.5 x ULN.
  • Bilirubin <=1.5 x ULN, except for subjects with Gilbert's syndrome.
  • Creatinine <=1.5 x ULN.
  • Subject is able to read, understand, and complete the questionnaires.

Exclusion criteria

  • Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
  • Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
  • Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6.
  • Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
  • Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
  • Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.

Treatment and study plan

SCH 619734 Dose 1

Drug

SCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)

Other names: Rolapitant

SCH 619734 Dose 2

Drug

SCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)

Other names: Rolapitant

SCH 619734 Dose 3

Drug

SCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)

Other names: Rolapitant

SCH 619734 Dose 4

Drug

SCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)

Other names: Rolapitant

Placebo

Drug

Matching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles)

Primary outcomes

  1. The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy).

    Time frame: Days 1 through 6.

Secondary outcomes

  1. The key secondary efficacy endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV.

    Time frame: Days 1 through 6.

  2. The key secondary safety endpoints are adverse events, physical examinations, vital signs, electrocardiograms, and safety laboratory values.

    Time frame: Throughout the study and up to 30 days after the subject completes or discontinues from the study.

Sponsors and collaborators

Lead sponsor

Schering-Plough

Industry

Registry information

Official study title

A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 2, 2006
Registry last updated
Oct 23, 2009

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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