Prostate CancerPhase 1/2NCT03837353
A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1
A Phase 1/2 study testing DKN-01 and Docetaxel in people with Prostate Cancer, run by NYU Langone Health at 5 sites in United States.
Trial summary
This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 [DKK1]) either in plasma or biopsy. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- DKN-01 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2019to 20 Sep 2022
- Phase
- Phase 1/2
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Have a histologically or cytologically confirmed cancer of prostate origin (adenocarcinoma, poorly differentiated carcinoma, or neuroendocrine carcinoma are all allowed).
- Patients with pure neuroendocrine carcinoma must have had at least one line of platinum-based chemotherapy unless the patient is intolerant of or is refusing chemotherapy.
- Patients with pure neuroendocrine carcinoma do not need to have been previously treated with androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide or apalutamide or darolutamide) but must have castrate testosterone and have castration-resistant disease.
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to C1D1 and must be continued throughout the study.
- Cohorts 1A, 1B: Patients must have progressed despite 1 or more androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide or apalutamide or darolutamide) and have not received prior taxane-based chemotherapy for prostate cancer. Prior treatment with an AR signaling inhibitor for castration-sensitive disease will be allowed if the time to progression was within 1 year after starting drug. Prior treatment with a taxane-based chemotherapy for castration-sensitive disease will be exclusionary. (Prior treatment with an AR signaling inhibitor is not required for pure prostate neuroendocrine carcinoma as in inclusion 2.)
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- Cohorts 2A and 2B: Patients must have progressed despite 1 or more AR signaling inhibitor (abiraterone or enzalutamide or apalutamide or darolutamide) and either had disease progression, were intolerant of, or refused 1 or more taxane-based chemotherapies for mCRPC. (Prior treatment with an AR signaling inhibitor is not required for pure prostate neuroendocrine carcinoma as in inclusion 2.)
- Cohort 1B. Patients must have measurable disease per RECIST v1.1 guidelines AND must have either:
- PSA progression is defined by Prostate Cancer Working Group 3 (PCWG3) criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 1 ng/mL, if PSA is the sole evidence of progression, OR
- Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3), OR
- Soft tissue progression on transaxial imaging: new or progressive soft tissue masses on computed tomography (CT) or magnetic resonance imaging (MRI) scans as defined by RECIST v1.1.
- Cohorts 1A, 2A, 2B. Patients must have baseline progression defined as one of the following:
- PSA progression is defined by PCWG3 criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 2 ng/mL.
- Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3).
- Soft tissue progression on transaxial imaging: new or progressive soft tissue masses on computed tomography (CT) or magnetic resonance imaging (MRI) scans as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Estimated life expectancy of at least 3 months, in the judgment of the Investigator.
- Required initial laboratory values within 14 days of C1D1:
- Total bilirubin within normal limits for the institution. (For Cohorts 2A and 2B, total bilirubin < 3 × ULN is acceptable with known liver metastases).
- For Cohorts 1A, 1B transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] ≤1.5 × the upper limit of normal (ULN). For Cohorts 2A and 2B, AST and ALT ≤ 5.0 × ULN is acceptable with known liver metastases.
- Creatinine ≤2.0 or calculated creatinine clearance ≥50 mL/min using the Cockcroft and Gault Method (Cockroft and Gault 1976).
- Absolute neutrophil count ≥1000 cells/µl.
- Absolute lymphocyte count ≥500/µl.
- Hemoglobin ≥8.5 g/dL.
- Platelet count ≥100,000 cells/µl. (For Cohorts 2A and 2B, Platelet count ≥75,000 cells/µl).
- International normalized ratio (INR) (prothrombin time [PT])/partial thromboplastin time (PTT) ≤1.5 × ULN unless receiving anticoagulant, in which case INR ≤3.0 and no active bleeding, (ie, no clinically significant bleeding within 14 days prior to first dose of study therapy.
- Sexually active male patients must agree to use adequate contraception (hormonal or barrier method of birth control) during the study and for 6 months after their last dose of study drug. Should a patient's partner become pregnant or suspect she is pregnant while participating in the study, the Investigator should be immediately informed.
- 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.
- Submission of a next-generation sequencing report from prostate cancer tissue or ctDNA from a CLIA certified lab if available. If no such report is available, a statement attesting to the lack of such a report is sufficient for eligibility.
Who cannot join
- Any anti-cancer therapy (with the exception of luteinizing hormone-releasing hormone [LHRH] analog or antagonist) within 2 weeks prior to initiation of study treatment.
- Any investigational anti-cancer therapy within 4 weeks of initiation of study treatment.
- New York Heart Association Class III or IV heart failure, or myocardial infarction within the past 6 months, or unstable arrhythmia within 3 months.
- Uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry.
- History of malignancy other than prostate cancer within 2 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as non-melanoma skin carcinoma or ductal carcinoma in situ.
- Known to be human immunodeficiency virus (HIV) positive, have positive hepatitis B surface antigen (HBSAg), or positive hepatitis C antibody (HCAb) test. (Hepatitis C antibody-positive patients with an undetectable hepatitis C virus (HCV) RNA will be eligible.)
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- History of solid organ transplant (ie, heart, lungs, liver, or kidney).
- History of autologous/allogenic bone marrow transplant.
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or Sponsor.
- Major surgical procedures or significant traumatic injury within 4 weeks prior to study entry (minor surgical procedures within 1 week of study entry). Note: Diagnostic cystoscopy is not exclusionary at any time during screening. History of osteonecrosis of the hip. Other hip pathology such as degenerative disease or malignant involvement are not exclusionary. Screening of asymptomatic patients is not required.
- Active or untreated central nervous system (CNS) malignancy or metastasis. Screening for CNS metastases of asymptomatic patients without a history of CNS metastases is not required. Patients with treated CNS metastases are eligible provided they meet all of the following criteria:
- Evaluable disease outside the CNS.
- No history of intracranial or intraspinal hemorrhage.
- No evidence of significant vasogenic edema.
- No ongoing requirement for corticosteroids as therapy for CNS disease. (Anti-convulsants at a stable dose for > one month is allowed.)
- No stereotactic radiation, whole brain radiation within 4 weeks of C1D1.
- Patients with CNS metastases treated by neurosurgical resection or brain biopsy within 3 month prior to C1D1 will not be allowed.
- Radiographic demonstration of interim stability (ie, no progression) between completion of CNS-directed therapy and the screening radiographic study.
- Screening CNS radiographic study ≥4 weeks since completion of radiotherapy or surgical resection and ≥2 weeks since discontinuation of corticosteroids.
- Any other condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- Active substance abuse.
- Receipt of any live vaccine within 30 days before the first dose of study treatment or anticipation that such a live vaccine will be required during study participation.
- Previously treated with an anti-DKK1 therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Veterans Affairs New York Harbor Healthcare System
New York, New York, 10010
NYU Langone Health
New York, New York, 10016
University of California, San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63130
About this study
This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 [DKK1]) either in plasma or biopsy. Other biopsies for correlative studies are encouraged but not mandatory. Pharmacokinetic (PK) testing of one pre-treatment blood sample and one post-treatment blood sample will be mandatory on Day 1 of every cycle.
- Conditions
- Prostate Cancer
- Being tested
- DKN-01, Docetaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKN-01Drug
DKN-01 is a large molecular weight protein that will be given as a flat dose on a Days 1 and 15 of a 21-day cycle in Dose-Escalation Cohort 1A and Dose-Expansion Cohort 1B. DKN-01 will be given on Days 1 and 15 on a 28-day cycle in Dose-Escalation Cohort 2A and Dose-Expansion Cohort 2B. The dose of DKN-01 will be administered as an intravenous (IV) infusion over 60 (±) 15 minutes.
DocetaxelDrug
Docetaxel will be administered as an IV infusion over approximately 60 (±15) minutes on day 1 of a 21-day cycle in Cohorts 1A and 1B. In Cohort 1A, docetaxel must be dosed at 75 mg/m2 on cycle 1 day 1. Docetaxel can be dosed at 75 mg/m2 or 60 mg/m2 in subsequent cycles depending on clinical discretion and dose modification guidelines. Regardless of dose, docetaxel must be dosed in 21-day cycles. In Cohort 1B, cycle 1 day 1 dosing of docetaxel will either be 75 mg/m2 or 60 mg/m2 depending on clinical discretion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | In dose-escalation Cohort 1A, the dose of docetaxel 75 mg/m2 will remain fixed. The DKN-01 dose level will start with 300 mg and be escalated to 600 mg or de-escalated to 150 mg depending on the absence or presence of identified DLTs. DKN-01 will be administered in combination with docetaxel on Day 1 and as monotherapy on Day 15 of each 21-day cycle. Patients will be treated with the combination of DKN-01 and Docetaxel until Prostate Cancer Working Group 3 (PCWG3) progression or unacceptable toxicity. Receives: Drug: DKN-01; Drug: Docetaxel |
| Cohort 1B | Experimental | In dose-expansion Cohort 1B, either the maximum tolerated dose (MTD) or highest dose tested of DKN-01 in combination with docetaxel in Cohort 1A will be the dose used. The dose of docetaxel 75 mg/m2 will remain fixed. DKN-01 will be administered in combination with docetaxel on Day 1 and as monotherapy on Day 15 of each 21-day cycle. Patients will be treated with the combination of DKN-01 and Docetaxel until PCWG3 progression or unacceptable toxicity. Receives: Drug: DKN-01; Drug: Docetaxel |
| Cohort 2A | Experimental | In dose-escalation Cohort 2A, DKN-01 dose level will start with 300 mg and be escalated to 600 mg or de-escalated to 150 mg depending on the absence or presence of identified DLTs. DKN-01 will be administered as monotherapy on Days 1 and 15 of each 28-day cycle. Patients will be treated with DKN-01 until PCWG3 progression or unacceptable toxicity. Receives: Drug: DKN-01 |
| Cohort 2B | Experimental | In dose-expansion Cohort 2B, the MTD or highest dose tested of DKN-01 monotherapy in Cohort 2A will be the dose used. DKN-01 will be administered as monotherapy on Days 1 and 15 of each 28-day cycle. Patients will be treated with DKN-01 until PCWG3 progression or unacceptable toxicity. Receives: Drug: DKN-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose Limiting Toxicities Observed by End of Treatment Cycle 1
Measured among Phase I dose-escalation cohorts (arms 1A.1, 1A.2, 2A.1, and 2A.2) only.
Measured: Up to End of Cycle 1 (Up to Day 21 for Cohort 1A, Up to Day 28 for Cohort 2A)
Number of Participants With a Best Overall Response of Complete Response (iCR) or Partial Response (iPR) Per iRECIST by End of Long-Term Follow-Up Period
iRECIST will be used by the Investigator to assess tumor response and progression. An iCR is defined as the disappearance of all target lesions as assessed by iRECIST; an iPR is defined as 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 iRECIST.
Measured: Up to Year 2 Post-Baseline
Secondary outcomes (3)
Progression-Free Survival (PFS)
Defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue as assessed by Investigator using iRECIST, in bone as assessed by Investigator using Prostate Cancer Working Group 3 (PCWG3), or death, whichever occurs first.
Measured: Up to Year 2 Post-Baseline
Number of Participants With a Decline in Prostate-Specific Antigen (PSA) of at Least 50% Relative to Baseline
Measured: Up to Year 2 Post-Baseline
Maximal Percent Change in PSA Measured After Treatment Initiation
Measured: Up to Year 2 Post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Apr 2019
- Primary completion19 Jul 2022
- Study completion20 Sep 2022
Why it stopped: Terminated early due to slow accrual in the context of changing practice patterns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Leap Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- David Wise, MD, PhD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837353
- Sponsor's protocol ID
- 17-01747
- Status last verified
- Dec 2023
- First submitted
- 22 Jan 2019
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Wise DR, Schneider JA, Armenia J, Febles VA, McLaughlin B, Brennan R, Thoren KL, Abida W, Sfanos KS, De Marzo AM, Yegnasubramanian S, Fox JJ, Haas M, Heath H, Kagey MH, Newman W, Sirard CA, Fleisher M, Morris MJ, Chen Y, Larson SM, Haffner MC, Nelson PS, Schultz N, Garabedian MJ, Scher HI, Logan SK, Sawyers CL; International SU2C/PCF Prostate Cancer Dream Team. Dickkopf-1 Can Lead to Immune Evasion in Metastatic Castration-Resistant Prostate Cancer. JCO Precis Oncol. 2020 Sep 29;4:PO.20.00097. doi: 10.1200/PO.20.00097. eCollection 2020.
PubMed 33015525
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1
- ClinicalTrials.gov ID
- NCT03837353
- Acronym / sponsor ID
- 17-01747
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to slow accrual in the context of changing practice patterns.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Leap Therapeutics, Inc.
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 [DKK1]) either in plasma or biopsy. Other biopsies for correlative studies are encouraged but not mandatory. Pharmacokinetic (PK) testing of one pre-treatment blood sample and one post-treatment blood sample will be mandatory on Day 1 of every cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: DKN-01, Drug: DocetaxelIn dose-escalation Cohort 1A, the dose of docetaxel 75 mg/m2 will remain fixed. The DKN-01 dose level will start with 300 mg and be escalated to 600 mg or de-escalated to 150 mg depending on the absence or presence of identified DLTs. DKN-01 will be administered in combination with docetaxel on Day 1 and as monotherapy on Day 15 of each 21-day cycle. Patients will be treated with the combination of DKN-01 and Docetaxel until Prostate Cancer Working Group 3 (PCWG3) progression or unacceptable toxicity. |
| Cohort 1B | Experimental | Drug: DKN-01, Drug: DocetaxelIn dose-expansion Cohort 1B, either the maximum tolerated dose (MTD) or highest dose tested of DKN-01 in combination with docetaxel in Cohort 1A will be the dose used. The dose of docetaxel 75 mg/m2 will remain fixed. DKN-01 will be administered in combination with docetaxel on Day 1 and as monotherapy on Day 15 of each 21-day cycle. Patients will be treated with the combination of DKN-01 and Docetaxel until PCWG3 progression or unacceptable toxicity. |
| Cohort 2A | Experimental | Drug: DKN-01In dose-escalation Cohort 2A, DKN-01 dose level will start with 300 mg and be escalated to 600 mg or de-escalated to 150 mg depending on the absence or presence of identified DLTs. DKN-01 will be administered as monotherapy on Days 1 and 15 of each 28-day cycle. Patients will be treated with DKN-01 until PCWG3 progression or unacceptable toxicity. |
| Cohort 2B | Experimental | Drug: DKN-01In dose-expansion Cohort 2B, the MTD or highest dose tested of DKN-01 monotherapy in Cohort 2A will be the dose used. DKN-01 will be administered as monotherapy on Days 1 and 15 of each 28-day cycle. Patients will be treated with DKN-01 until PCWG3 progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Age >18 years.
- Have a histologically or cytologically confirmed cancer of prostate origin (adenocarcinoma, poorly differentiated carcinoma, or neuroendocrine carcinoma are all allowed).
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to C1D1 and must be continued throughout the study.
- Cohorts 1A, 1B: Patients must have progressed despite 1 or more androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide or apalutamide or darolutamide) and have not received prior taxane-based chemotherapy for prostate cancer. Prior treatment with an AR signaling inhibitor for castration-sensitive disease will be allowed if the time to progression was within 1 year after starting drug. Prior treatment with a taxane-based chemotherapy for castration-sensitive disease will be exclusionary. (Prior treatment with an AR signaling inhibitor is not required for pure prostate neuroendocrine carcinoma as in inclusion 2.)
- Cohorts 2A and 2B: Patients must have progressed despite 1 or more AR signaling inhibitor (abiraterone or enzalutamide or apalutamide or darolutamide) and either had disease progression, were intolerant of, or refused 1 or more taxane-based chemotherapies for mCRPC. (Prior treatment with an AR signaling inhibitor is not required for pure prostate neuroendocrine carcinoma as in inclusion 2.)
Key exclusion criteria (23 listed)
- Any anti-cancer therapy (with the exception of luteinizing hormone-releasing hormone [LHRH] analog or antagonist) within 2 weeks prior to initiation of study treatment.
- Any investigational anti-cancer therapy within 4 weeks of initiation of study treatment.
- New York Heart Association Class III or IV heart failure, or myocardial infarction within the past 6 months, or unstable arrhythmia within 3 months.
- Uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry.
- History of malignancy other than prostate cancer within 2 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as non-melanoma skin carcinoma or ductal carcinoma in situ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKN-01DKN-01 is a large molecular weight protein that will be given as a flat dose on a Days 1 and 15 of a 21-day cycle in Dose-Escalation Cohort 1A and Dose-Expansion Cohort 1B. DKN-01 will be given on Days 1 and 15 on a 28-day cycle in Dose-Escalation Cohort 2A and Dose-Expansion Cohort 2B. The dose of DKN-01 will be administered as an intravenous (IV) infusion over 60 (±) 15 minutes. | Drug | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B |
| DocetaxelDocetaxel will be administered as an IV infusion over approximately 60 (±15) minutes on day 1 of a 21-day cycle in Cohorts 1A and 1B. In Cohort 1A, docetaxel must be dosed at 75 mg/m2 on cycle 1 day 1. Docetaxel can be dosed at 75 mg/m2 or 60 mg/m2 in subsequent cycles depending on clinical discretion and dose modification guidelines. Regardless of dose, docetaxel must be dosed in 21-day cycles. In Cohort 1B, cycle 1 day 1 dosing of docetaxel will either be 75 mg/m2 or 60 mg/m2 depending on clinical discretion. | Drug | Cohort 1A, Cohort 1B |
Primary outcome
Number of Dose Limiting Toxicities Observed by End of Treatment Cycle 1
Time frame: Up to End of Cycle 1 (Up to Day 21 for Cohort 1A, Up to Day 28 for Cohort 2A)
Measured among Phase I dose-escalation cohorts (arms 1A.1, 1A.2, 2A.1, and 2A.2) only.
Number of Participants With a Best Overall Response of Complete Response (iCR) or Partial Response (iPR) Per iRECIST by End of Long-Term Follow-Up Period
Time frame: Up to Year 2 Post-Baseline
iRECIST will be used by the Investigator to assess tumor response and progression. An iCR is defined as the disappearance of all target lesions as assessed by iRECIST; an iPR is defined as 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 iRECIST.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to Year 2 Post-Baseline
Number of Participants With a Decline in Prostate-Specific Antigen (PSA) of at Least 50% Relative to Baseline
Time frame: Up to Year 2 Post-Baseline
Maximal Percent Change in PSA Measured After Treatment Initiation
Time frame: Up to Year 2 Post-Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33015525Wise DR, Schneider JA, Armenia J, Febles VA, McLaughlin B, Brennan R, Thoren KL, Abida W, Sfanos KS, De Marzo AM, Yegnasubramanian S, Fox JJ, Haas M, Heath H, Kagey MH, Newman W, Sirard CA, Fleisher M, Morris MJ, Chen Y, Larson SM, Haffner MC, Nelson PS, Schultz N, Garabedian MJ, Scher HI, Logan SK, Sawyers CL; International SU2C/PCF Prostate Cancer Dream Team. Dickkopf-1 Can Lead to Immune Evasion in Metastatic Castration-Resistant Prostate Cancer. JCO Precis Oncol. 2020 Sep 29;4:PO.20.00097. doi: 10.1200/PO.20.00097. eCollection 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wise, MD, PhD principal investigator
New York Langone Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DKN-01 and Docetaxel in people with Prostate Cancer, run by NYU Langone Health at 5 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 30 inclusion and 23 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: stopped early, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 18 Dec 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 Dose Limiting Toxicities Observed by End of Treatment Cycle 1 (time frame: Up to End of Cycle 1 (Up to Day 21 for Cohort 1A, Up to Day 28 for Cohort 2A)). 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 NCT03837353, 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 18 Dec 2023.