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Endometrial CancerPhase 2P204NCT03395080

A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma

A Phase 2 study testing Paclitaxel, 300mg DKN-01 and 600mg DKN-01 in people with Endometrial Cancer and Uterine Cancer, run by Leap Therapeutics, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination with Paclitaxel in Patients With Recurrent Epithelial Endometrial Cancer, Epithelial Ovarian Cancer, or Carcinosarcoma Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer, Uterine Cancer, Ovarian Cancer
What is being tested?
Paclitaxel, 300mg DKN-01 and 600mg DKN-01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
17 sitesUnited States
Study dates
5 Mar 2018to 27 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis:
  • Epithelial Endometrial Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent previously treated EEC.
  • Epithelial Ovarian Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent platinum-resistant/refractory EOC, primary peritoneal, or fallopian tube cancer (i.e., disease recurrence within 6 months of completion of or progression during platinum-based chemotherapy).
  • Carcinosarcoma/Malignant Mixed Mullerian Tumors: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent uterine or ovarian carcinosarcoma (MMMT). Patients must have had only 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have been included chemotherapy (including in adjuvant setting), chemotherapy and radiotherapy, and/or consolidation/maintenance therapy.
  • Refractory or intolerant to at least one prior standard therapy(ies) for metastatic or locally advanced disease (see Inclusion Criterion #1c for Groups 5-6).
  • If prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy.
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  • Prior treatment with paclitaxel as part of definitive therapy regimen is acceptable, provided the patient is not intolerant of paclitaxel.
  • Patients who are not eligible to receive paclitaxel will be allowed to receive single agent DKN-01.
  • Tumor tissue for mandatory pre-treatment and on-treatment biopsies.
  • One or more tumors measurable on radiographic imaging as defined by RECIST 1.1.
  • Ambulatory and ≥18 years of age.
  • ECOG performance status (PS) of 0 or 1
  • ECOG PS of 2 may be eligible upon the review and approval of the Medical Monitor.
  • Estimated life expectancy of at least 3 months, in the judgment of the Investigator.
  • Disease-free of active second/secondary or prior malignancies for ≥2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
  • Acceptable liver, renal, hematologic and coagulation function
  • Females of child bearing potential and male partners of female patients must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study-specific procedures.
  • Provided written informed consent prior to any study-specific procedures.

Who cannot join

  • Patients with the following pure histologies of endometrial or ovarian cancer are not eligible for enrollment: germ cell, sex cord stroma, or sarcoma.
  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
  • Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital long QT syndrome.
  • Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
  • Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb), unless hepatitis C virus ribonucleic acid (HCV RNA) undetected/negative.
  • History of major organ transplant (i.e., heart, lungs, liver, or kidney).
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  • History of autologous/allogenic bone marrow transplant.
  • Serious nonmalignant disease
  • Pregnant or nursing.
  • History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
  • Symptomatic central nervous system (CNS) malignancy or metastasis.
  • Known osteoblastic bony metastasis
  • Treatment with surgery or chemotherapy within 21 days prior to study entry (42 days for nitrosoureas or mitomycin C)
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to study entry.
  • Clinically significant peripheral neuropathy at the time of study entry. Patients with pre-existing peripheral neuropathy will be allowed to receive single agent DKN-01
  • History of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil). Patients who exhibit these hypersensitivities will be eligible to receive single agent DKN-01
  • Prior radiation therapy within 14 days prior to study entry
  • Currently receiving any other investigational agent or received an investigational agent within last 30 days of study entry.
  • Previously treated with an anti-DKK1 therapy
  • Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
  • Active substance abuse

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Alabama

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • The University of Tennessee West Cancer Center

    Germantown, Tennessee, 38138

  • Ohio State University Wexner Medical Center

    Hilliard, Ohio, 43026

  • HCA Midwest Health System Clinical Research

    Kansas City, Missouri, 64132

  • University of Wisconsin

    Madison, Wisconsin, 53715

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Stephenson Cancer Center - University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Florida Cancer Specialists & Research Institute

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial, Epithelial Ovarian Cancer, or Carcinosarcoma

A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination with Paclitaxel in Patients With Recurrent Epithelial Endometrial Cancer, Epithelial Ovarian Cancer, or Carcinosarcoma

Read the detailed description

This study employs a "basket" design to concurrently investigate DKN-01 as monotherapy and in combination with paclitaxel in patients with recurrent epithelial endometrial cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (malignant mixed Mullerian tumor [MMMT]. Thus, 6 distinct patient groups are being independently investigated:

  1. 300mg DKN-01 monotherapy in recurrent EEC (Group 1)
  2. 300mg DKN-01+paclitaxel in recurrent EEC (Group 2)
  3. 300mg DKN-01 monotherapy in recurrent EOC (Group 3)
  4. 300mg DKN-01+paclitaxel in recurrent EOC (Group 4)
  5. 600mg DKN-01 monotherapy in recurrent carcinosarcoma (MMMT) (Group 5)
  6. 600mg DKN-01+paclitaxel in recurrent carcinosarcoma (MMMT) (Group 6)
Being tested
Paclitaxel, 300mg DKN-01, 600mg DKN-01
Keywords
epithelial histology, Wnt pathway, DKK1, endometrial, uterine, ovarian, carcinosarcoma
Medical subject headings
Endometrial Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Carcinosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

    Administered by IV infusion

  • 300mg DKN-01Drug

    Administered by IV infusion

  • 600mg DKN-01Drug

    Administered by IV infusion

Study groups in NCT03395080
Study groupRoleWhat they receive
DKN-01 monotherapy in recurrent EECExperimental300mg DKN-01 monotherapy in recurrent EEC
Receives: Drug: 300mg DKN-01
DKN-01+paclitaxel in recurrent EECExperimental300mg DKN-01+paclitaxel in recurrent EEC
Receives: Drug: Paclitaxel; Drug: 300mg DKN-01
DKN-01 monotherapy in recurrent EOCExperimental300mg DKN-01 monotherapy in recurrent EOC
Receives: Drug: 300mg DKN-01
DKN-01+paclitaxel in recurrent EOCExperimental300mg DKN-01+paclitaxel in recurrent EOC
Receives: Drug: Paclitaxel; Drug: 300mg DKN-01
DKN-01 monotherapy in carcinosarcomaExperimental600mg DKN-01 monotherapy in carcinosarcoma
Receives: Drug: 600mg DKN-01
DKN-01 +paclitaxel in carcinosarcomaExperimental600mg DKN-01 +paclitaxel in carcinosarcoma
Receives: Drug: Paclitaxel; Drug: 600mg DKN-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients

    Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to <10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

    Measured: Baseline to study completion (approximately 6 months)

  2. Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients

    Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to <10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

    Measured: Baseline to study completion (approximately 6 months)

Secondary outcomes (6)

  1. Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

    Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to <10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)

    Measured: Baseline to study completion (approximately 6 months)

  2. Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

    Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.

    Measured: Baseline to study completion (maximum 17.6 months)

  3. Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

    Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.

    Measured: Baseline to study completion (maximum 7.1 months)

  4. Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

    Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.

    Measured: Baseline to study completion (approximately 11 months)

  5. Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

    Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.

    Measured: Baseline to study completion (approximately 11 months)

  6. Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

    Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.

    Measured: Baseline to study completion (approximately 13.1 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start5 Mar 2018
  3. Primary completion9 Sep 2020
  4. Study completion27 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395080
Sponsor's protocol ID
DEK-DKK1-P204
Acronym
P204
Status last verified
May 2023
First submitted
2 Jan 2018
Last updated
1 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Arend R, Dholakia J, Castro C, Matulonis U, Hamilton E, Jackson CG, LyBarger K, Goodman HM, Duska LR, Mahdi H, ElNaggar AC, Kagey MH, Liu A, Piper D, Barroilhet LM, Bradley W, Sachdev J, Sirard CA, O'Malley DM, Birrer M. DKK1 is a predictive biomarker for response to DKN-01: Results of a phase 2 basket study in women with recurrent endometrial carcinoma. Gynecol Oncol. 2023 May;172:82-91. doi: 10.1016/j.ygyno.2023.03.013. Epub 2023 Mar 29.

    PubMed 37001446

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, 300mg DKN-01 and 600mg DKN-01 in people with Endometrial Cancer and Uterine Cancer, run by Leap Therapeutics, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients (time frame: Baseline to study completion (approximately 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395080, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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