Amsterdam UMC aims to develop new treatments that improve care and outcomes for all patients in the future. Participation in Phase I–II research contributes to this.
What is Phase I research?
Phase I research in oncology, also known as early-phase research, is the first step in clinical drug development in which a new medicine or a new combination of medicines is studied in patients with cancer. At Amsterdam UMC, these studies are conducted within the Amsterdam UMC Early Phase Oncology & Hematology Trial Center, our dedicated centre for early-phase research in oncology and hematology.
These studies take place after a new drug has already been tested in the laboratory. At this stage, the medicine is administered to humans for the first time, or a new combination of medicines is given for the first time to a small group of patients with the condition the treatment is intended for.
In Phase I oncology studies, the primary focus is on safety and possible side effects, in order to determine the appropriate dosage and method of administration. In addition, early signals of effectiveness are also explored. If a treatment proves to be sufficiently safe in Phase I, it can proceed to Phase II clinical research, where its effectiveness is further evaluated.
What is Phase II research?
Phase II research is the next step in clinical drug development. In this phase, a new medicine or treatment is studied further after Phase I has shown that side effects are acceptable in treating the disease.
In Phase II, the treatment is tested in a larger group of patients with the specific condition for which it is intended.
Key aspects of Phase II research include:
Effectiveness
The main goal is to evaluate how well the treatment works in the target patient group. Researchers assess whether the treatment has the intended effect on the disease.
Further safety evaluation
Although safety and side effects have already been assessed in Phase I, monitoring continues in Phase II to better understand risks and side effects in a larger group of patients.
Who participates in Phase I–II studies?
Early-phase studies typically include patients diagnosed with the type of cancer for which the new treatment is being developed. Many Phase I–II studies at Amsterdam UMC also allow participation from patients with different types of cancer.
These patients often have few or no effective standard treatment options remaining and are looking for new possibilities, such as immunotherapy. Together with your treating physician, you can discuss whether you may be eligible for participation. If so, you may be referred to Amsterdam UMC.
Why is participation in Phase I–II research important?
Phase I–II research plays a crucial role in the development of future treatments. Patients often participate when standard treatment options are limited, although some studies also focus on earlier stages of disease.
Participation may provide access to new treatments that are not yet widely available.
While the primary focus in these early phases is on safety and tolerability, early-phase research is an essential step in advancing cancer treatment. Amsterdam UMC aims to develop new therapies that improve care and outcomes for future patients, and participation in Phase I–II research contributes directly to this goal.
It is important to emphasize that there is no guarantee of personal benefit from participation. Especially when a treatment is being tested in humans for the first time, the likelihood of direct benefit is small. In fact, it is more realistic not to expect personal benefit. Participation can also be intensive, and treatments may cause side effects. It is therefore important to carefully consider participation and discuss this with your loved ones.
How are Phase I–II studies conducted?
Phase I and II studies are carried out in relatively small groups of patients to assess the safety, dosage, and side effects of new cancer treatments.
Because participation can be demanding and specific eligibility criteria apply, you will always discuss with your physician whether a Phase I–II study is a suitable option.
Patients who participate are supported by an experienced team of physicians and research nurses. They are closely monitored throughout the study. Where needed, supportive care is provided to help manage symptoms related to the disease and to treat any side effects.
Participation is entirely voluntary. Patients have the right to withdraw from the study at any time, without giving a reason.
The early-phase team of the departments of Medical Oncology, Hematology, and Pulmonology at Amsterdam UMC, location De Boelelaan (VUmc), specializes in conducting Phase I and II clinical trials of new cancer treatments and therapeutic strategies.
Participation in a Phase I study can be intensive and may be burdensome, particularly if you do not live near Amsterdam UMC. It is important to discuss this carefully with your physician.