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Trial record 5 of 12 for:    DKN-01

Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04681248
Expanded Access Status : Available
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Leap Therapeutics, Inc.

Brief Summary:
An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.

Condition or disease Intervention/treatment
Esophageal Neoplasm Adenocarcinoma of the Gastroesophageal Junction GastroEsophageal Cancer Squamous Cell Carcinoma Gastric Adenocarcinoma Endometrial Cancer Uterine Cancer Ovarian Cancer Carcinosarcoma Gastric Cancer Drug: DKN-01

Detailed Description:
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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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors



Intervention Details:
  • Drug: DKN-01
    Administered by IV infusion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681248


Contacts
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Contact: Cyndi Sirard, MD 617-714-0357 csirard@leaptx.com

Locations
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United States, Alabama
University of Alabama Available
Birmingham, Alabama, United States, 35294
Contact    203-441-7938    DKN01.EAP@earlyaccesscare.com   
United States, California
Cedars Sinai Medical Care Foundation Available
Los Angeles, California, United States, 90025
Contact    203-441-7938    DKN01.EAP@earlyaccesscare.com   
United States, Illinois
Northwestern University Available
Chicago, Illinois, United States, 60611
Contact    203-441-7938    DKN01.EAP@earlyaccesscare.com   
United States, Wisconsin
University of Wisconsin Available
Madison, Wisconsin, United States, 53715
Contact    203-441-7938    DKN01.EAP@earlyaccesscare.com   
Sponsors and Collaborators
Leap Therapeutics, Inc.
Investigators
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Study Director: Cyndi Sirard, MD Leap Therapeutics
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Responsible Party: Leap Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04681248    
Other Study ID Numbers: DEK-DKK1-P206
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Keywords provided by Leap Therapeutics, Inc.:
DKK1
DKN-01
epithelial histology
Wnt pathway
endometrial
uterine
ovarian
carcinosarcoma
gastric cancer
gastroesophageal junction
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Endometrial Neoplasms
Esophageal Neoplasms
Uterine Neoplasms
Carcinosarcoma
Mixed Tumor, Mullerian
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Uterine Diseases
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue