If you or a loved one have been diagnosed with an aggressive blood cancer, a clinical trial studying the potential of a new targeted treatment could be an option. Continue reading to learn more about two ongoing trials and see if you are eligible to enroll.
HOW YOUR CANCER GENETICS CAN HELP YOU FIND POTENTIAL TREATMENT OPTIONS
Cancer is caused by changes to specific genes that control how our cells grow and divide. Some cancers are characterized by increased activity of a protein called Positive Transcription Elongation Factor B (P-TEFb). P-TEFb plays a central role in helping cancer cells survive and thrive by increasing levels of specific genes. MYC and BCL2 are some of these genes.
Increased MYC is estimated to be involved in over 70% of cancers1 . If you aren’t sure if MYC is involved in your or your loved one’s cancer, ask your doctor. He or she can help get genetic testing completed to better understand your cancer.
1Dang CV. MYC on the path to cancer. Cell. 2012;149(1):22-35. doi:10.1016/j.cell.2012.03.003
About the Phase 1 Clinical Trial of Enitociclib
Enitociclib (aka VIP152) is a P-TEFb inhibitor, meaning it works to block the activity of P-TEFb. Blocking P-TEFb stops a series of signals that can lead to tumor growth, and, as a result, treatment with enitociclib is expected to decrease the production of cancer-promoting genes, such as MYC and MCL1. For patients whose cancers are driven by MYC, blocking P-TEFb at the beginning of the pathway which drives cancer growth may be a way to slow or stop tumor growth and disease progression.
Tumor Growth & Progression
Controls Tumor Growth & Progression in Preclinal Studies
There are currently two clinical trials underway studying enitociclib in aggressive blood cancers. The trial that you may qualify for depends on the specific type of blood cancer you have, and its specific characteristics.
Eligibility for Trial A
Double-hit diffuse large B-cell lymphoma
- Men and women aged ≥18 years
- Confirmed disease
- Adequate bone marrow, liver, and renal functions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected life expectancy of >3 months
- Active clinically serious infections of Grade >2
- Subjects who have new or progressive brain or meningeal or spinal metastases
- Anticancer therapy during the study or within 1 week before the first dose of study drug
- Major surgery or significant trauma within 4 weeks before the first dose of study drug
- Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug (Subjects must have completed immunosuppressive therapy before enrollment)
A clinical trial is a controlled study where an investigational drug is evaluated in humans. The purpose of a clinical trial is to evaluate the safety and efficacy (how well it works) of an investigational drug. To participate in a clinical trial, you must meet all eligibility criteria and be willing to following the directions of the study doctor. Throughout the study, a team of nurses, doctors and trial coordinators will be closely working with you. They will monitor any symptoms or changes and ensure you are comfortable and informed throughout the process
No compensation will be provided, but all study drugs will be provided to you at no cost
Talk to your doctor about the type of aggressive blood cancer you have and if you might be eligible for either of the clinical trials
If you aren’t sure if MYC is involved in your or your loved one’s cancer, ask your doctor. He or she can help get genetic testing completed to better understand your cancer. You can learn more about this type of genetic testing here
A previous study has shown VIP152 to be generally well-tolerated. One side effect was neutropenia (low levels of white blood cells). This side effect may be a good sign that the drug is working; however, some patients may require treatment with other medications to increase their white blood cell count if it becomes too low
Findings from a previous study suggest that VIP152 has the potential to treat patients with advanced and/or aggressive cancers, including some blood cancers, with MYC amplification, overexpression, or translocation who have not been helped by current treatment options
See below for a map of our current trial sites