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Developmental Therapeutics Program

At the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC), our specialists are at the center of developing new therapies for cancer. Many of these emerging therapies originate from SKCCC research laboratories. The Developmental Therapeutics Program connects patients at our cancer center to these pivotal early-stage therapies for cancer.

What are Phase I clinical trials?

Phase I trials are the first in a series of four stages in testing new therapies in humans. These studies may involve experimental treatments under development by pharmaceutical or biotechnology companies, or ones being studied exclusively by Johns Hopkins scientists. These trials may also test new combinations of already available drugs. The primary goal of these studies is to determine whether the therapy can be given safely. Because little is known about how these drugs will be tolerated in humans, phase I clinical trials typically enroll a limited number of patients to ensure patient safety. There are no placebos (sugar pills) in phase I clinical trials.

What are Phase II clinical trials?

Phase II trials typically enroll several hundred people across multiple cancer centers.  The primary goal of these studies is to continue to assess safety of the new treatment in a larger group of people, and to determine how well it works against specific types of cancer. Another goal of these studies is to understand how the drugs may be fighting the cancer, and so the studies may involve collection of blood or tissue samples.

Our Team

Nilofer Azad, M.D., Assistant Professor of Medical Oncology and Chemical Therapeutics
Roisin Connolly, M.B.B.Ch., Assistant Professor of Medical Oncology
Michelle A. Rudek, Ph.D., Pharm.D., Associate Professor of Oncology
Denise Gallagher R.N., Referral Nurse

For general questions about clinical trials in the Developmental Therapeutics Program, please contact our Referral Nurse at 410-502-5140 or phase1trials@jhmi.edu 

What kinds of drugs are available in our clinical trials?

Our clinical trials include various classes of experimental drugs.  These treatments are given by themselves or in combination with other therapies, and include drugs such as immune, epigenetic and targeted agents as well as new versions of traditional chemotherapies.  Many of our clinical trials use a personalized medicine approach, matching a tumor’s unique genetic profile to a targeted treatment.

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What are the risks and benefits of joining a Phase I or II clinical trial?

Patients enrolled in clinical trials often express their wish to make an important contribution in advancing new treatments for future cancer patients. Early phase clinical trials offer additional choices for therapies that are on the cusp of cancer research and have shown promise in laboratory testing. Since most phase I clinical trials involve agents that have been tested in the laboratory on animals, there is less information on the risks and side effects of the therapy in humans. Your safety is of utmost importance, and our team will monitor you very closely for any side effects while on a clinical trial.