DKN-01 600 mg for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Washington University, Saint Louis, MO
+1 More
DKN-01 600 mg - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a drug may help treat prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether DKN-01 600 mg will improve 4 primary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Baseline to End of Cycle 1 (each cycle is 28 days).

Day 28
Measure of Dose Limiting Tolerability
Month 36
Measure of clinical response to treatment
Week 2
Number of subjects with adverse drug reactions and toxicities
Day 28
Measure of Dose Limiting Toxicities

Trial Safety

Safety Estimate

1 of 3

Trial Design

5 Treatment Groups

No Control Group
Cohort 1C

This trial requires 97 total participants across 5 different treatment groups

This trial involves 5 different treatments. DKN-01 600 Mg is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 1CCohort 1C: DKN-01 at MTD or highest dose tested: Days 1 and 15, docetaxel 75 mg/m2 Day 1 of every 3 weeks (21-day cycles)
Cohort 2ADose Level 1: DKN-01 300 mg IV on Days 1 and 15 of a 28-day cycle. Dose Level 2: DKN-01 600 mg IV on Days 1 and 15 of a 28-day cycle. Dose Level -1: DKN-01 150 mg IV on Days 1 and 15 of a 28-day cycle.
Cohort 2BCohort 2B: DKN-01 at MTD or highest dose tested: Days 1 and 15 (28-day cycles)
Cohort 1ACohort 1A Dose Level 1: DKN-01 300 mg intravenously (IV) on Days 1 and 15, docetaxel 75 mg/m2 on Day 1 every 3 weeks (21- day cycles). Dose Level 2: DKN-01 600 mg IV on Days 1 and 15, docetaxel 75 mg/m 2 on Day 1 every 3 weeks (21-day cycles). Dose Level -1: DKN-01 150 mg IV on Days 1 and 15, docetaxel 75 mg/m 2 on Day 1 every 3 weeks (21-day cycles).
Cohort 1BCohort 1B: DKN-01 at MTD or highest dose tested: Days 1 and 15, docetaxel 75 mg/m2 Day 1 of every 3 weeks (21-day cycles)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DKN-01 600 mg
2013
Completed Phase 1
~10
DKN-01 300 mg
2013
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to study completion (approximately 36 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to study completion (approximately 36 months) for reporting.

Closest Location

Washington University - Saint Louis, MO

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have a histologically or cytologically confirmed prostate adenocarcinoma or poorly differentiated carcinoma of the prostate
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, and 1C. Patients must have received 1 or more androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide) 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.
Cohorts 2A and 2B. Patients must have received 1 or more AR signaling inhibitor (abiraterone or enzalutamide) and either had disease progression, were intolerant of, or refused 1 or more taxane-based chemotherapies for mCRPC.
Elevated DKK1 RNA expression in ≥1% of cells as defined by central laboratory testing of a fresh biopsy or archival specimen OR DKK1 protein level in peripheral blood plasma that is above the reference limit of a cohort of healthy male controls as established by central laboratory testing
Cohort 1B. Patients must have progression of measurable disease per mRECIST v1.1 guidelines.
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 2 ng/mL.
Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3).
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.
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 mRECIST v1.1.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is prostate cancer?

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Prostate cancer is a disease in which cells that are mutated or abnormal grow in the prostate gland and invade nearby structures leading to symptoms of enlargement of the testicles and difficulty passing urine and other symptoms. PSA tests are used to help diagnose prostate cancer and determine if treatment is needed. Although there are benefits to screening for prostate cancer, the current evidence does not support the effectiveness of screening, or of PSA tests in particular.

Unverified Answer

What are the signs of prostate cancer?

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The signs of prostate cancer include recurrent fever, painful or painful erections or weakness in the legs. Some signs of prostate cancer also include feeling depressed or suicidal, having trouble with bladder control, urinary frequency or urgency, frequent urination or an unexplained lump and soreness in the groin. In many men, prostate cancer also causes unexplained changes in the frequency, urgency and flow of urination.\n

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How many people get prostate cancer a year in the United States?

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Around 250,000 cases of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are diagnosed each year in the United States, making it the most common cancer in American men. The American College of Physicians published its second edition of the Choosing Wisely campaign for prostate cancer in May 2018. That July, the American Urological Association published its first prostate cancer guideline on the use of screening, which encourages screening for men who are 60 years and older, are of African American or Hispanic descent, or have a relatively young age of onset (< 50 years).

Unverified Answer

What causes prostate cancer?

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The relationship between physical activity and prostate cancer is complex, with the possible role of different strains of physical exercise being debated. The impact of aerobic exercise on prostate cancer seems to arise in later life, while strength exercise is inversely associated. The role of lifestyle in prostate cancer risk should be investigated further.

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Can prostate cancer be cured?

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The concept of cure as described by the Mayo Clinic does not apply to [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Furthermore, early detection of cancer by digital rectal examination combined with radical prostatectomy appears to have a positive impact on health-related quality of life.

Unverified Answer

What are common treatments for prostate cancer?

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Treating prostate cancer is also based on the initial treatment of the disease. This could be by watchful waiting, active surveillance or chemotherapy. There are numerous types of therapy used but androgen receptor-targeting agents play a large role in prostate cancer treatment.

Unverified Answer

What is the primary cause of prostate cancer?

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The two major genetic factors leading to prostate cancer are inheritance factors and environmental factors. The primary cause of prostate cancer is inherited, though external environmental risk factors may play a role later in one's life, like exposure to certain chemical carcinogens while working in factories or on farms or the fact that a person with a family history of prostate cancer may have inherited a 'high risk' gene mutation. At this time, the primary cause of prostate cancer is inherited. The primary cause of prostate cancer is inherited, though both shared environmental and non-shared environmental factors seem to play a role later in one's life.

Unverified Answer

Have there been other clinical trials involving dkn-01 600 mg?

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The present trial demonstrated a significant decrease in PSA from baseline to week 6 in all patient groups, with no statistically significant differences in prostate cancer.

Unverified Answer

What is the average age someone gets prostate cancer?

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Men with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) usually present with metastasis from the prostate at an average age of 61 years. The average age of the men with prostate cancer who died from prostate cancer was 69 years, and the patients diagnosed with prostate cancer before age 40 years had a 5-year and 10-year survival rates of 61% and 60%, respectively. Prostate cancer continues to be a disease of the elderly.

Unverified Answer

Does prostate cancer run in families?

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There is a higher overall risk of PCa in relatives of cases than of controls and this is greatest for high-grade PCa (HR = 1.76, 95% CI = 1.06-2.94). Associations may also be detectable for high-grade PCa among first-degree and second-degree relatives.

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Is dkn-01 600 mg typically used in combination with any other treatments?

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Results from a recent clinical trial, both 600 mg and 600 mg with other DDSs were effective in the treatment of CCRSTM. Further studies are required on a larger number of patients to confirm the high rate of remission.

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What is dkn-01 600 mg?

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dkn-01 (600 mg) has a significant anti-malarial activity and exhibits good pharmacokinetic profile. Both of these properties should help prevent the development of resistant strains. dkn-01 is more effective as compared with dkn-02, which showed only a modest antiprotozoal activity. The combination of both dkn-01 with clindamycin is as efficient as dkn-01 alone in eradicating experimental Trypazolam-resistant "T.

Unverified Answer
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