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Phase 2B Double-blind Placebo-controlled Crossover Study Evaluating the Efficacy of Intravenous Fosaprepitant for Chemotherapy-induced Nausea and Vomiting (CINV) Associated With High-dose Interleukin-2 (HD IL-2) for Metastatic Melanoma and Metastatic Renal Cell Carcinoma

Phase 2
18 Years
90 Years
Not Enrolling
Chemotherapy-induced Nausea and Vomiting

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Trial Information

Phase 2B Double-blind Placebo-controlled Crossover Study Evaluating the Efficacy of Intravenous Fosaprepitant for Chemotherapy-induced Nausea and Vomiting (CINV) Associated With High-dose Interleukin-2 (HD IL-2) for Metastatic Melanoma and Metastatic Renal Cell Carcinoma

This is a Phase 2B double-blind placebo-controlled crossover study evaluating the efficacy
of intravenous fosaprepitant for chemotherapy-induced nausea and vomiting in patients
undergoing high-dose interleukin-2 (HD IL-2) therapy (720,000 IU/kg per dose intravenously;
14 doses, 2 cycles per course) for metastatic melanoma and metastatic renal cell carcinoma.
A total of 22 subjects will be enrolled in the study. On study entry, patients will be
randomized to receive either IV fosaprepitant (150 mg on Day 1, Day 3, or Day 5) or matched
placebo during first admission of HD IL-2 therapy (cycle 1). All subjects will crossover
and receive the opposite treatment during cycle 2. All patients will receive ondansetron 24
mg by mouth daily per standard protocol every 24 hours during Days 1-5 of admission starting
30 minutes prior to first dose of HD IL-2. During the treatment phase, subjects will receive
Patients will receive IV fosaprepitant 30 minutes before first dose of HD IL-2 therapy and
every 48 hours until completion of HD IL-2 therapy. Upon study entry, the subjects will be
given a dairy to report episodes of vomiting, use of rescue therapy, and nausea assessments
using the 1-100 scale within the visual analogue scale (VAS). The subject will be
instructed to complete entries from baseline assessment (prior to first dose) until 5 days
after last dose of HD IL-2 for endpoint analysis. During inpatient admissions, subjects
will complete diary entries before each dose (q8 hours). As an outpatient, subjects will
complete diary entries on a daily basis. Recording of whether or not pruritus was observed
will also be collected within the subject diary. If a patient reports pruritus, the
severity of pruritus on the 1-100 scale visual analogue scale (VAS) will also be collected.
The study team will record any episodes of vomiting and the use of rescue therapy and ensure
completion of patient diary during inpatient portion. Assessments will be made via
telephone contact to determine onset of any episodes of CINV during outpatient portion.
Safety assessments including adverse events (AEs) monitoring will be performed and assessed
using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Inclusion Criteria:

- Subjects must meet all of the following inclusion criteria to be eligible for
enrollment into the study:

1. Evidence of a personally signed and dated informed consent document indicating
that the subject (or legally acceptable representative) has been informed of all
pertinent aspects of the trial.

2. Subjects who are willing to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

3. Be at least 18 years of age at the time of informed consent.

4. Has a diagnosis of metastatic melanoma or metastatic renal cell carcinoma and
who will undergo high-dose interleukin-2 (HD IL-2) therapy

5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or
less at Baseline/Day 1 visit. (See Appendix 6 on p. 51, ECOG Performance

6. Female of reproductive potential must agree use non-hormonal methods to avoid
pregnancy during study participation and for 1 month after last dose of study

Exclusion Criteria:

- Subjects presenting with any of the following will not be included in the study:

1. Women who are pregnant or lactating, or planning pregnancy

2. Women of childbearing potential who refuse to use non-hormonal methods to avoid

3. Known hypersensitivity to any component of fosaprepitant or aprepitant

4. Have taken pimozide or cisapride <4 weeks, cytochrome P450 3A4 inducers within
30 days, strong CYP3A4 inhibitors within 7 days, or antiemetics within 48 hours
prior to treatment initiation (See Appendix 7 on p. 52 for list of CYP3A4
inducers and strong CYP3A4 inhibitors)

5. Have evidence of clinically significant and unstable diseases or conditions such
as cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal,
endocrine, collagen-vascular, or gastrointestinal abnormalities that the
investigator thinks may interfere with study participation

6. Participation in other study using an investigational or experimental therapy or
procedure within 4 weeks or 5 half-lives (whichever is longer) before study

7. Subjects cannot participate in studies of other investigational or experimental
therapies or procedures at any time during their participation in this study.

8. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
may interfere with the interpretation of study results and, in the judgment of
the investigator, would make the subject inappropriate for entry into this

9. Subjects who are investigational site staff members or who are Sponsor employees
directly involved in the conduct of the trial.

10. A subject who, in the opinion of the investigator or sponsor, will be
uncooperative or unable to comply with study procedures.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Complete response during inpatient admission

Outcome Description:

No vomiting during inpatient admissions

Outcome Time Frame:

10 weeks

Safety Issue:


Principal Investigator

John M Richart, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Louis University, Department of Internal Medicine, Division of Hematology and Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

October 2015

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • melanoma
  • renal cell carcinoma
  • interleukin-2
  • Carcinoma
  • Carcinoma, Renal Cell
  • Melanoma
  • Nausea
  • Vomiting



Saint Louis University HospitalSt. Louis, Missouri  63110-0250