Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors
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An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.
Condition or disease
Esophageal NeoplasmAdenocarcinoma of the Gastroesophageal JunctionGastroEsophageal CancerSquamous Cell CarcinomaGastric AdenocarcinomaEndometrial CancerUterine CancerOvarian CancerCarcinosarcomaGastric Cancer
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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