NCT01189903 - 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)

Goh BC, Fleming GF, Janisch L, Vogelzang NJ, Stadler WM, Ratain MJ
Development of a schedule-dependent population pharmacodynamic model for rhizoxin without quantitation of plasma concentrations. Cancer Chemother Pharmacol. 2000;45(6):489-94.
Vokes EE, Goh BC, Bertucci D, Vogelzang NJ, Mani S, Ratain MJ
A Phase I study of raltitrexed and paclitaxel given every 3 weeks to patients with solid tumors. Cancer. 1999 Aug 1;86(3):528-32.

Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

Clinical trial NCT01189903 - References