This is a Phase 1 multi-center, open-label study that allows subjects who derived
clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101
study to continue treatment with IGN002. Subjects who completed the IGN002-101 study,
tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible
to participate in this study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02847949.
In this extension study, IGN002 study drug will initially be administered at the same
dose level and schedule that the subject was receiving at the conclusion of the Spectrum
sponsored IGN002-101 study. If additional safety and PK data from another Spectrum
sponsored IGN002 study support a higher dose level that is deemed safe and well tolerated
by the Safety Review Committee (SRC), the dose of IGN002 may be increased within a given
subject. However, dose levels of IGN002 in this extension study may not exceed the
maximum tolerated dose (MTD). In addition, the dose for a given subject may be lowered
per Investigator discretion. Each treatment cycle comprises a total of 8 doses of IGN002
administered at weekly intervals.
Subjects will be evaluated at the study clinic before each dose of IGN002. At each study
visit, standard of care assessments will be performed, which will include physical
examination, measurement of vital signs, documentation of adverse events (AEs) and
concomitant medications, and laboratory analyses of blood and urine. Radiological
assessments will be performed at the end of each 8-week cycle. Tumor status will be
assessed by comparison to the subject's baseline tumor status, as determined in the
separate study, IGN002-101, or tumor nadir, if the subject has demonstrated response.
Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from
IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues
the study for any reason, an early termination (ET) visit will be conducted 30 (±3) days
after the last dose of IGN002. This visit will include physical examination, vital sign
measurements, laboratory analyses of blood and urine, and documentation of AEs and
concomitant medications.
Lead OrganizationSpectrum Pharmaceuticals Inc
