Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

Browse trials for

• Nausea 822
• Vomiting 1,100

Keywords

• NK-1 Receptor Antagonist, CINV, Emesis, MEC

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 1,015 is above the median of 115 across 703 interventional studies indexed under Nausea.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  Fosaprepitant Regimen

  On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, \~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) \~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO \~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO \~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

  Drug: Fosaprepitant dimeglumine · Drug: Dexamethasone · Drug: Ondansetron · Drug: Dexamethasone Placebo · Drug: Ondansetron Placebo · Drug: Rescue Therapy

• Active comparator
  Control Regimen

  On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, \~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO \~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO \~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

  Drug: Fosaprepitant Placebo · Drug: Dexamethasone · Drug: Ondansetron · Drug: Rescue Therapy

Interventions

• DrugFosaprepitant dimeglumine

  Also known as: EMEND for Injection, MK-0517

• DrugFosaprepitant Placebo
• DrugDexamethasone

  Also known as: Decadron

• DrugOndansetron

  Also known as: Zofran

• DrugDexamethasone Placebo
• DrugOndansetron Placebo
• DrugRescue Therapy

Primary outcomes

1. Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)

   A Complete Response was defined as no vomiting and no use of rescue medication.

   Time frame: 25 to 120 hours after initiation of MEC

2. Percentage of Participants With Infusion-site Thrombophlebitis

   The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.

   Time frame: Day 1 through Day 17, inclusive

3. Percentage of Participants With Severe Infusion-site Reactions

   The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.

   Time frame: Day 1 through Day 17, inclusive

Secondary outcomes

1. Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC

   A Complete Response was defined as no vomiting and no use of rescue medication.

   Time frame: 0 to 120 hours after initiation of MEC

2. Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC

   A Complete Response was defined as no vomiting and no use of rescue medication.

   Time frame: 0 to 24 hours after initiation of MEC

3. Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC

   No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.

   Time frame: 0 to 120 hours after initiation of MEC

Baseline characteristics

Publications

• Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8. PubMed 26449391 ↗
• Weinstein C, Jordan K, Green S, Khanani S, Beckford-Brathwaite E, Vallejos W, Pong A, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type. BMC Cancer. 2020 Sep 25;20(1):918. doi: 10.1186/s12885-020-07259-5. PubMed 32988373 ↗
• Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Pong A, Noga SJ, Rapoport BL. Evaluation of factors contributing to the response to fosaprepitant in a heterogeneous, moderately emetogenic chemotherapy population: an exploratory analysis of a randomized phase III trial. Support Care Cancer. 2018 Nov;26(11):3773-3780. doi: 10.1007/s00520-018-4242-x. Epub 2018 May 28. PubMed 29808377 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf