An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.
This is a intermediate-size Expanded Access Protocol (EAP). Patients who were receiving DKN-01 in a parent study at the time of completion of the parent study, and are, in the opinion of the Investigator and Sponsor, suitable candidates for continued study drug treatment are eligible for participation in the current EAP. In this EAP, all patients will receive DKN-01 at the same dose and schedule as at the time of completion of the parent study. Furthermore, patients who received DKN-01 in combination in the parent study will continue to receive the same combination agent at the same dose and schedule in the EAP.
Administered by IV infusion
Inclusion Criteria: - Must be ≥18 years of age - Receiving DKN-01 in a parent study and, in the opinion of the Investigator and Leap, is a suitable candidate for continued study drug treatment at the completion of the parent study - In the Investigator's opinion, demonstrated acceptable tolerability of study drug - In the Investigator's opinion, is receiving clinical benefit from treatment with DKN-01, either as monotherapy or in combination with another treatment in the parent study - In the Investigator's opinion, demonstrated acceptable compliance with study drug and the study procedures in the parent study and is willing and able to comply with all procedures in the current study. - After consultation with the Medical Monitor, DKN-01 may be continued for a patient who has met the criteria for Progressive Disease (PD) but, in the Investigator's opinion, is receiving clinical benefit - For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months following the last dose of study drug - Signed informed consent must be obtained prior to the initiation of any study-required procedures.
Patients with any of the following characteristics will be ineligible for study entry: - Any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study - Permanent discontinuation of DKN-01 in the parent study due to toxicity - Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or Leap Medical Monitor or designee - Patient has experienced Progressive Disease (PD) that, in the opinion of the Investigator, precludes further study treatment. - Patient requires use of a prohibited concomitant medication or therapy listed in the parent study - Females who are breastfeeding or pregnant, and females and males planning a pregnancy - Current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
University of Alabama
Birmingham, Alabama, 35294
Cedars Sinai Medical Care Foundation
Los Angeles, California, 90025
Chicago, Illinois, 60611
University of Wisconsin
Madison, Wisconsin, 53715
Cyndi Sirard, MD
Cyndi Sirard, MD