Clinical Trial Details
Braintumor Website

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NCT01874119 : Fosaprepitant for Nausea and Vomiting During High-dose Interleukin-2 (HD IL-2) for Metastatic Melanoma and Renal Cell Carcinoma
PhasePhase 2
AgesMin: 18 Years Max: 90 Years
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.
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