NCT00001436 - 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)

Kappel CC, Velez-Yanguas MC, Hirschfeld S, Helman LJ
Human osteosarcoma cell lines are dependent on insulin-like growth factor I for in vitro growth. Cancer Res. 1994 May 15;54(10):2803-7.
Malaab SA, Pollak MN, Goodyer CG
Direct effects of tamoxifen on growth hormone secretion by pituitary cells in vitro. Eur J Cancer. 1992;28A(4-5):788-93.
Pollak M, Sem AW, Richard M, Tetenes E, Bell R
Inhibition of metastatic behavior of murine osteosarcoma by hypophysectomy. J Natl Cancer Inst. 1992 Jun 17;84(12):966-71.

A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma

Clinical trial NCT00001436 - References