CLINICAL TRIAL

Doxercalciferol (GZ427397) for Neoplasm Metastasis

Stage III
Waitlist Available · < 65 · All Sexes · New York, NY

Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

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About the trial for Neoplasm Metastasis

Eligible Conditions
Neoplasm Metastasis · Secondary Hyperparathyroidism, Chronic Kidney Disease · Renal Insufficiency, Chronic · Hyperparathyroidism, Secondary · Hyperparathyroidism · Kidney Diseases

Treatment Groups

This trial involves 2 different treatments. Doxercalciferol (GZ427397) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Doxercalciferol (GZ427397)
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Calcitriol
DRUG

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People with chronic kidney disease (CKD) stage 3 or 4 who are not on dialysis are defined as having a glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m^2 at Week -2 visit. show original
A patient's iPTH value is greater than 100 pg/mL for CKD Stage 3 or greater than 160 pg/mL for CKD Stage 4 at their Week -2 visit. show original
The text refers to anyone aged between 5 and 18 years old who is either male or female. show original
The weight of an object must be at least 15 kg. show original
Signed informed consent/assent form.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12
Screening: ~3 weeks
Treatment: Varies
Reporting: At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Doxercalciferol (GZ427397) will improve 1 primary outcome and 4 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of Baseline up to Week 12.

Percentage of participants achieving two consecutive ≥30% reductions in iPTH
BASELINE UP TO WEEK 12
BASELINE UP TO WEEK 12
Number of participants with adverse events
BASELINE UP TO WEEK 24
BASELINE UP TO WEEK 24
Percentage change from baseline in iPTH
BASELINE, WEEK 12, WEEK 24
BASELINE, WEEK 12, WEEK 24
Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)
UP TO WEEKS 12 AND 24
UP TO WEEKS 12 AND 24
Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data
AT WEEK -2, BASELINE, AND THEN WITHIN 24 HOURS OF THE MOST RECENT DOSE OF HECTOROL® AT WEEKS 2, 4, 6, 8 OR 10 (WHICHEVER WEEK IS NOT USED FOR SERIAL PK ASSESSMENT), AND 12
AT WEEK -2, BASELINE, AND THEN WITHIN 24 HOURS OF THE MOST RECENT DOSE OF HECTOROL® AT WEEKS 2, 4, 6, 8 OR 10 (WHICHEVER WEEK IS NOT USED FOR SERIAL PK ASSESSMENT), AND 12

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 are the chances of developing neoplasm metastasis?

The incidence of the development of PM metastasis is higher than that of OSCC or NPC and it is also a significant cause of the death in patients.

Anonymous Patient Answer

What does doxercalciferol (gz427397) usually treat?

It was concluded that the study found no difference between the drugs in terms of efficacy, side effect profile, and pain management. The study found differences in cost between calcipotriol, etidronate and etidronic acid.

Anonymous Patient Answer

What is the average age someone gets neoplasm metastasis?

The average age that a cancer patient gets metastasis is 62 years (average 63). In most people, that is more than the average age of all Americans. It is, therefore, worthwhile searching for cancer and the neoplasm metastasis. Of course, if you do have cancer, check with your doctor.

Anonymous Patient Answer

Have there been other clinical trials involving doxercalciferol (gz427397)?

To our knowledge there are no other clinical trials which have evaluated the use of doxercalciferol as a first line therapy for patients with metastatic breast cancer.

Anonymous Patient Answer

Who should consider clinical trials for neoplasm metastasis?

A significant number of practitioners may be interested in clinical trials of neoplasm metastasis, but further research is needed to provide evidence-based recommendations for patient selection.

Anonymous Patient Answer

What are common treatments for neoplasm metastasis?

In summary, according to our review, most commonly used treatments for neoplasm metastasis are not specifically approved by the FDA or are not well-studied by the FDA and may be only partially effective.

Anonymous Patient Answer

What causes neoplasm metastasis?

It should not be overlooked that neoplasm metastases are caused by neoplasmal genetic and other factors other than tumor cells. Moreover, neoplasm metastasis is influenced by metastatic target tissues. Lymph node metastasis in breast cancer is one of the most common reasons for neoplasm metastasis.

Anonymous Patient Answer

What is neoplasm metastasis?

Neoplasm metastasis is the result of cancer cells that have been released, by shedding of cells, from their primary tumors into the blood or distant organs. It can cause a range of disorders, from chronic pain to death. Neoplasm metastasizing is most often diagnosed by CT and MRI examinations. The process of metastasis is also called'migration' of neoplastic cells.

Anonymous Patient Answer

How many people get neoplasm metastasis a year in the United States?

Around 928,000 neoplasm metastases were diagnosed in the United States annually. Most of these cases (60%) were caused by cancers. Nearly 40% were caused by breast and prostate cancers, while other malignancies were responsible for approximately 10% of metastases. The most common cancer diagnosed in conjunction with neoplasm metastasis was non-Hodgkin's lymphoma, making neoplasm metastasis the second most common cause of cancer-related deaths in children, adolescent, and adult males, after leukemia diagnoses.

Anonymous Patient Answer

What are the signs of neoplasm metastasis?

Different sites of metastasis have different characteristics and signs, and metastasis in distant organs tends to take longer to develop and thus is often not discovered before death from the primary neoplasm has occurred. The signs of metastases are similar to the primary neoplasm; however, distant metastases tend to be more solid and painless.

Anonymous Patient Answer

Does neoplasm metastasis run in families?

In a recent study, findings indicate that family history and age determine the probability of metastatic spread. Those with a positive family history and older age are at higher risk of metastasis. In contrast, most patients with a negative family history do not present with disseminated disease when analyzed by age.

Anonymous Patient Answer
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