NCT03395080 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-08-01

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · NOT POSTED

Number of Subjects With Response to Therapy in Patients With and Without Activating β-catenin Mutations and/or Wnt Signaling Genetic Alterations in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)

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outcome · NOT POSTED

Dickkopf-1 (DKK1) Concentration in Serum and Plasma Relative to Safety and Efficacy Outcomes in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).

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outcome · NOT POSTED

Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v5.0 of DKN-01 600 mg +/- Paclitaxel in Patients With Recurrent Carcinosarcoma (MMMT) in Carcinosarcoma (MMMT) Patients

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outcome · NOT POSTED

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

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outcome · NOT POSTED

Maximum Plasma Concentration (Cmax)

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outcome · NOT POSTED

Time Taken to Reach the Maximum Plasma Concentration (Tmax)

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outcome · NOT POSTED

Area Under the Curve (AUC)

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outcome · NOT POSTED

Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v4.03 as DKN-01 as Monotherapy or in Combination With Paclitaxel in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)

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outcome · NOT POSTED

Number of Subjects With Adverse Drug Reactions and Toxicities to Study Treatment Regimen in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT) as Evaluated by NCI CTCAE v5.0

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outcome · NOT POSTED

Concentration of DKN-01 Antibodies in Human Serum in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Diagnosis: 1. Epithelial Endometrial Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent previously treated EEC. 2. 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). 3. 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. 2. 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). 1. If prior therapy consisted of palliative chemoradiation therapy, it will be considered one line of therapy. 2. Prior treatment with paclitaxel as part of definitive therapy regimen is acceptable, provided the patient is not intolerant of paclitaxel. 3. Patients who are not eligible to receive paclitaxel will be allowed to receive single agent DKN-01. 3. Tumor tissue for mandatory pre-treatment and on-treatment biopsies. 4. One or more tumors measurable on radiographic imaging as defined by RECIST 1.1. 5. Ambulatory and ≥18 years of age. 6. ECOG performance status (PS) of 0 or 1 a. ECOG PS of 2 may be eligible upon the review and approval of the Medical Monitor. 7. Estimated life expectancy of at least 3 months, in the judgment of the Investigator. 8. 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. 9. Acceptable liver, renal, hematologic and coagulation function 10. 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. 11. Reliable and willing to make themselves available for the duration of the study and are willing to follow study-specific procedures. 12. Provided written informed consent prior to any study-specific procedures. Exclusion Criteria: 1. Patients with the following pure histologies of endometrial or ovarian cancer are not eligible for enrollment: germ cell, sex cord stroma, or sarcoma. 2. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia. 3. Fridericia-corrected QT interval (QTcF) \> 470 msec (female) or history of congenital long QT syndrome. 4. Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy. 5. 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. 6. History of major organ transplant (i.e., heart, lungs, liver, or kidney). 7. History of autologous/allogenic bone marrow transplant. 8. Serious nonmalignant disease 9. Pregnant or nursing. 10. 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. 11. Symptomatic central nervous system (CNS) malignancy or metastasis. 12. Known osteoblastic bony metastasis 13. Treatment with surgery or chemotherapy within 21 days prior to study entry (42 days for nitrosoureas or mitomycin C) 14. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to study entry. 15. 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 16. 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 17. Prior radiation therapy within 14 days prior to study entry 18. Currently receiving any other investigational agent or received an investigational agent within last 30 days of study entry. 19. Previously treated with an anti-DKK1 therapy 20. Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient 21. Active substance abuse
gender Based: true
gender Description: gender identity
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
300mg DKN-01 monotherapy in recurrent EEC
intervention Names
Drug: 300mg DKN-01
label
DKN-01 monotherapy in recurrent EEC
type
EXPERIMENTAL
description
300mg DKN-01+paclitaxel in recurrent EEC
intervention Names
Drug: Paclitaxel
Drug: 300mg DKN-01
label
DKN-01+paclitaxel in recurrent EEC
type
EXPERIMENTAL
description
300mg DKN-01 monotherapy in recurrent EOC
intervention Names
Drug: 300mg DKN-01
label
DKN-01 monotherapy in recurrent EOC
type
EXPERIMENTAL
description
300mg DKN-01+paclitaxel in recurrent EOC
intervention Names
Drug: Paclitaxel
Drug: 300mg DKN-01
label
DKN-01+paclitaxel in recurrent EOC
type
EXPERIMENTAL
description
600mg DKN-01 monotherapy in carcinosarcoma
intervention Names
Drug: 600mg DKN-01
label
DKN-01 monotherapy in carcinosarcoma
type
EXPERIMENTAL
description
600mg DKN-01 +paclitaxel in carcinosarcoma
intervention Names
Drug: Paclitaxel
Drug: 600mg DKN-01
label
DKN-01 +paclitaxel in carcinosarcoma
type
EXPERIMENTAL

interventions

arm Group Labels
DKN-01 +paclitaxel in carcinosarcoma
DKN-01+paclitaxel in recurrent EEC
DKN-01+paclitaxel in recurrent EOC
description
Administered by IV infusion
name
Paclitaxel
other Names
Taxol
type
DRUG
arm Group Labels
DKN-01 monotherapy in recurrent EEC
DKN-01 monotherapy in recurrent EOC
DKN-01+paclitaxel in recurrent EEC
DKN-01+paclitaxel in recurrent EOC
description
Administered by IV infusion
name
300mg DKN-01
type
DRUG
arm Group Labels
DKN-01 +paclitaxel in carcinosarcoma
DKN-01 monotherapy in carcinosarcoma
description
Administered by IV infusion
name
600mg DKN-01
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 111
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Number of Subjects With Response to Therapy in Patients With and Without Activating β-catenin Mutations and/or Wnt Signaling Genetic Alterations in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
time Frame
Baseline to study completion (approximately 6 months)
measure
Dickkopf-1 (DKK1) Concentration in Serum and Plasma Relative to Safety and Efficacy Outcomes in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (approximately 6 months)
measure
Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v5.0 of DKN-01 600 mg +/- Paclitaxel in Patients With Recurrent Carcinosarcoma (MMMT) in Carcinosarcoma (MMMT) Patients
time Frame
Baseline to study completion (approximately 6 months)
measure
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
time Frame
Baseline to study completion (approximately 6 months)
measure
Maximum Plasma Concentration (Cmax)
time Frame
Baseline to study completion (approximately 6 months)
measure
Time Taken to Reach the Maximum Plasma Concentration (Tmax)
time Frame
Baseline to study completion (approximately 6 months)
measure
Area Under the Curve (AUC)
time Frame
Baseline to study completion (approximately 6 months)
measure
Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v4.03 as DKN-01 as Monotherapy or in Combination With Paclitaxel in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
time Frame
Baseline to study completion (approximately 6 months)
measure
Number of Subjects With Adverse Drug Reactions and Toxicities to Study Treatment Regimen in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT) as Evaluated by NCI CTCAE v5.0
time Frame
Baseline to study completion (approximately 6 months)
measure
Concentration of DKN-01 Antibodies in Human Serum in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
time Frame
Baseline to study completion (approximately 6 months)

primary Outcomes

description
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)
measure
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
time Frame
Baseline to study completion (approximately 6 months)
description
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)
measure
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
time Frame
Baseline to study completion (approximately 6 months)

secondary Outcomes

description
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)
measure
Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (approximately 6 months)
description
Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.
measure
Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (maximum 17.6 months)
description
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.
measure
Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (maximum 7.1 months)
description
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.
measure
Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (approximately 11 months)
description
Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.
measure
Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (approximately 11 months)
description
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.
measure
Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
time Frame
Baseline to study completion (approximately 13.1 months)

Full study description

brief 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
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)

Source references

references

citation
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.
pmid
37001446
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice