A Phase II Study of IPI-204, A Novel Hsp90 Inhibitor in NSCLC Patients With ALK Translocations
- Participants will receive the study drug (IPI-504) twice weekly for two weeks followed
by 10 days without study treatment. This 3-week period is called a cycle. Participants
will receive a total of 4 doses per cycle. On the days the participant receives study
drug, they will come to the clinic and be given the IPI-504 by being. Participants
will continue to receive study drug for additional cycles as long as they are
benefiting from it and do not experience any severe side effects.
- Participants will have CT scans to assess the size and location of their tumor. They
may also have a PET scan or a combination of PET/CT scans. Imaging will be done at the
beginning of treatment and every five to six weeks while on study to assess how the
tumor is responding to IPI-504.
- The following tests and procedures will be done on the prior to the first dose of
IPI-504: physical examination, vital signs, routine blood tests, EKGs, serum or urine
pregnancy test (for women of child-bearing potential).
- After the first dose of IPI-504, the following tests and procedures will be done: EKGs,
vital signs (pulse only).
- For all other visit days throughout the study, the following exams, tests and
procedures will be done: physical examination, vital signs, blood tests, tumor imaging
assessments, MRI of the brain (if applicable), review of medications and answer
questions about any side effects or changes in health.
- After the final dose of study drug the following tests and procedures will be done
within 30 days: physical examination, ECOG Performance status, blood tests, review of
medications and answer questions about any side effects of changes in health.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the potential anti-tumor activity of IPI-504 based on validated markers of response, including imaging studies as measured by RECIST criteria. A response rate of PR or better or SD lasting 3 months or more that is no greater than 5% will be considered evidence that IPI-504 is ineffective for this indication.
Lecia V. Sequist, MD, MPH
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|