Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Vomiting

Treatments: Drug: placebo to dexamethasone; Drug: dexamethasone; Drug: aprepitant; Drug: ondansetron; Drug: rescue medication; Drug: placebo to aprepitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080444

2004_099 (Other Identifier)

MK-0869-097 (Other Identifier)

Formerly-0304AHEC

0869-097

Details and patient eligibility

About

This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.

Full description

The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional, open-label, 28-day cycles.

Enrollment: 50 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cycle 1: Participant is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented malignancy. OR Participant did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
• Cycle 1: Participant has Karnofsky score ≥60
• Cycle 1: Participant has a predicted life expectancy of ≥3 months

Exclusion criteria

• Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups

Part 1: Aprepitant

Experimental group

Description:

Day 1: aprepitant 125 mg orally (PO), ondansetron 0.15 mg/kg x 3 doses intravenously (IV), dexamethasone 8 mg PO. Day 2: aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 4 mg PO. Day 3: aprepitant 80 mg PO, dexamethasone 4 mg PO. Day 4: dexamethasone 4 mg PO. For 1 cycle and up to 9 subsequent optional cycles.

Treatment:

Drug: dexamethasone

Drug: rescue medication

Drug: ondansetron

Drug: aprepitant

Drug: placebo to dexamethasone

Part 1: Standard Therapy

Active Comparator group

Description:

Day 1: placebo to aprepitant 125 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 16 mg PO. Day 2: placebo to aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 8 mg PO. Day 3: placebo for aprepitant 80 mg PO, dexamethasone 8 mg PO. Day 4: dexamethasone 8 mg PO. For 1 cycle; participants may receive open-label aprepitant for up to 9 subsequent optional cycles.

Treatment:

Drug: dexamethasone

Drug: rescue medication

Drug: placebo to aprepitant

Drug: ondansetron

Part 2: Aprepitant

Active Comparator group

Description:

Day 1: aprepitant 125 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 8 mg PO. Day 2: aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 4 mg PO. Day 3: aprepitant 80 mg PO, dexamethasone 4 mg PO. Day 4: dexamethasone 4 mg PO. For up to 10 cycles.

Treatment:

Drug: dexamethasone

Drug: rescue medication

Drug: ondansetron

Drug: aprepitant

Drug: placebo to dexamethasone