NCT00005991 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Rivera E, Valero V, Arun B, Royce M, Adinin R, Hoelzer K, Walters R, Wade JL 3rd, Pusztai L, Hortobagyi GN
Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. J Clin Oncol. 2003 Sep
Rivera E, Valero V, Esteva FJ, Syrewicz L, Cristofanilli M, Rahman Z, Booser DJ, Hortobagyi GN
Lack of activity of stealth liposomal doxorubicin in the treatment of patients with anthracycline-resistant breast cancer. Cancer Chemother Pharmacol. 2002 Apr;49(4):299-302. Epub 2001 Dec 18.

Phase I/II Study of Gemcitabine and Doxil Combination Chemotherapy in Patients With Advanced Solid Tumors (Phase I)/Breast Cancer (Phase II)

Clinical trial NCT00005991 - References