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Radioisotope Therapy

AlphaMedix for Neuroendocrine Cancer (ALPHAMEDIX02 Trial)

Phase 2
Recruiting
Research Sponsored by Radiomedix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sufficient bone marrow capacity and organ function in the recent blood tests within 3 weeks prior to Day 1, as defined by: White blood cell (WBC) ≥2,500/ mm3; Absolute neutrophil count (ANC) ≥1000/mm3; Platelets ≥100,000/mm3; Hemoglobin (HgB) ≥9.0 g/dL; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3 X upper limit of normal (ULN); Total Bilirubin: ≤2 X ULN; Serum creatinine ≤1.7 mg/dL; Serum albumin ≥3.0 g/L; if lower than 3.0 g/L requires normal range prothrombin time (PT) and international normalized ratio (INR), and Be willing to practice the following medically acceptable methods of birth control (both women of childbearing potential (WOCBP) and men who have partners of childbearing potential) from the Screening Visit through 3 months after the final administration 212Pb-DOTAMTATE
Subjects must have received and progressed following somatostatin analog administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after last dose administration
Awards & highlights

ALPHAMEDIX02 Trial Summary

This trial is testing a new cancer treatment for people with neuroendocrine tumors.

Who is the study for?
Adults over 18 with advanced neuroendocrine tumors (NET) that can't be removed by surgery or have spread, and who've had disease progression after previous treatments. Participants must have a life expectancy of at least 12 weeks, adequate organ function, and confirmed somatostatin receptors on their tumors. Pregnant women, those with certain heart conditions or infections like HIV/Hepatitis B/C, recent recipients of similar therapies, or individuals with uncontrolled health issues are excluded.Check my eligibility
What is being tested?
The trial is testing AlphaMedix (212Pb-DOTAMTATE), a targeted radiotherapy for NET patients who either haven't received peptide receptor radionuclide therapy (PRRT naive) or have previously undergone PRRT. It's a Phase 2 study to see how well this treatment works in controlling the disease.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from radiotherapies like AlphaMedix may include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation due to radiation exposure could also occur.

ALPHAMEDIX02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened after treatment with somatostatin analogs.
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My cancer has worsened within the last year and can be measured.
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My recent blood tests show my organs and bone marrow are working well.
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My cancer shows high activity on specific scans compared to normal liver.
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All my cancer lesions have somatostatin receptors, confirmed by a recent PET/CT scan.
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My cancer has worsened within the last year and can be measured.
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My cancer shows high activity on specific scans compared to normal liver.
Select...
I am able to get out of my bed or chair and move around.
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My cancer has visible signs on scans that meet specific criteria.
Select...
I am 18 or older with a NET that cannot be surgically removed or has spread.
Select...
My condition worsened after receiving somatostatin analog treatment.
Select...
I can take care of myself and am up and about more than half of the day.

ALPHAMEDIX02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after last dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after last dose administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Number of patients with treatment-related adverse events as assessed by CTCAE v.4.0
Secondary outcome measures
Measurement of Overall Survival (OS)
Measurement of Time to Tumor Progression (TTP)
Measurement of the Median Progression free survival (mPFS)
+3 more

Side effects data

From undefined Phase 2 trial • 4 Patients • NCT00005906
25%
Gastrointestinal disorders
25%
Liver function abnormalities
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide

ALPHAMEDIX02 Trial Design

1Treatment groups
Experimental Treatment
Group I: Pb212-DOTAMTATEExperimental Treatment1 Intervention
investigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors in PRRT naive patients (Cohort 1) and previous PRRT patients (Cohort 2)

Find a Location

Who is running the clinical trial?

Radiomedix, Inc.Lead Sponsor
6 Previous Clinical Trials
701 Total Patients Enrolled
4 Trials studying Neuroendocrine Tumors
465 Patients Enrolled for Neuroendocrine Tumors
Orano Med LLCIndustry Sponsor
3 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
33 Patients Enrolled for Neuroendocrine Tumors

Media Library

AlphaMedix (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05153772 — Phase 2
Neuroendocrine Tumors Research Study Groups: Pb212-DOTAMTATE
Neuroendocrine Tumors Clinical Trial 2023: AlphaMedix Highlights & Side Effects. Trial Name: NCT05153772 — Phase 2
AlphaMedix (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153772 — Phase 2
Neuroendocrine Tumors Patient Testimony for trial: Trial Name: NCT05153772 — Phase 2

Frequently Asked Questions

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

What precedent has AlphaMedix established in terms of conducting medical tests?

"Currently, there are 16 clinical studies pertaining to AlphaMedix with 5 trials in Phase 3. Whilst the majority of these investigations take place in Trabzon and Florida, a total of 792 centres globally offer research into this medication."

Answered by AI

Are there any vacancies for prospective participants in this investigation?

"Affirmative, the clinical trial is open for recruitment as per records on clinicaltrials.gov. The medical study was initiated on December 21st 2021 and most recently updated on January 5th 2022; it seeks to enroll 34 participants from a single site."

Answered by AI

How many participants have signed up for this trial thus far?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical research is currently in search of 34 patients from a single centre. The project was initially posted on December 21st 2021 and most recently edited on January 5th 2022."

Answered by AI

What indications is AlphaMedix regularly utilized to address?

"AlphaMedix has been found to be effective in managing the symptoms of acromegaly, octreotide use and long-term maintenance therapy."

Answered by AI

What potential hazards can be associated with AlphaMedix consumption?

"AlphaMedix has been attributed a safety score of 2, as the current Phase 2 trial only provides limited evidence on its efficacy and some data supporting safety."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Florida
Minnesota
Other
How old are they?
65+
18 - 65
What site did they apply to?
Excel Diagnostics and Nuclear Oncology Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I searched new for my therapy.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Excel Diagnostics and Nuclear Oncology Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients
2021. "Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153772.
All > Neuroendocrine Tumor
~35 spots leftby Oct 2026
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