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Prostate CancerPhase 1NCT03030885

Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 1 study testing 131I-MIP-1095 in people with Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study to determine the safety of an experimental medicine called 131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by the U.S. Food \& Drug Administration (FDA). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
131I-MIP-1095
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
19 Jan 2017to 2 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males, age ≥18 years.
  • Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate
  • Subjects must be castration resistant with evidence of progressive prostate cancer despite castrate levels of testosterone (≤ 50 ng/dL) according to the PCWG3 criteria
  • Subjects must have metastatic disease detectable by either bone scan or cross sectional imaging by CT or MRI as per the PCWG3 guidelines
  • Subjects must have progressive disease at study entry defined as 1 or more of the following 3 criteria that occurred while the subject was on androgen deprivation therapy:
  • PSA progression defined by a minimum of two rising PSA levels with an interval of ≥1 week between each determination. Subjects who received an anti-androgen as part of their primary hormonal therapy must demonstrate progression after withdrawal. The PSA value at screening should be ≥ 2 μg/L (2 ng/mL).
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  • Soft tissue disease progression defined by RECIST 1.1
  • Bone disease progression defined by PCWG3 with two or more new lesions on bone scan.
  • Note: For subjects enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan performed during prior therapy. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression
  • Subjects who received combined androgen blockade as their first-line hormonal therapy with an antiandrogen must have shown PSA progression after discontinuing the antiandrogen for ≥ 6 weeks prior to study treatment. No washout is needed after abiraterone or enzalutamide are discontinued. First generation antiandrogens such as bicalutamide must be withdrawn if given as first-line therapy.
  • ECOG Performance status of 0-1.
  • Adequate organ reserve as evidenced by:
  • neutrophil count ≥ 1500 μL
  • platelet count ≥ 100,000/μL
  • hemoglobin ≥ 9.5 g/dL
  • total bilirubin level ≤1.5 x ULN
  • AST and ALT ≤2.5 x ULN
  • serum amylase ≤ ULN
  • lipase ≤ ULN
  • serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (Cockroft Gault equation)
  • clearance of 99mTc MAG3 within 1.5 x ULN and no evidence of obstruction on the scan.
  • Serum albumin of > 3.0 g/dL
  • Subjects must have received, were ineligible to receive, or refused at least one cytotoxic chemotherapy and enzalutamide or abiraterone or both enzalutamide and abiraterone.
  • Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
  • Life expectancy ≥ 6 months

Who cannot join

  • Subject has predominant histologically or cytologically confirmed neuroendocrine prostate cancer (mixed histology is permissible, as is positivity of serum CgA and CEA).
  • Subject has received an investigational therapeutic agent for prostate cancer within 4 weeks prior to the administration of 131I-MIP-1095.
  • Subject who has not recovered from the effects of any major surgery prior to initial treatment
  • Subject has received treatment with a systemic therapeutic radioisotope (89Sr, 223Ra dichloride, 153Sm-lexidronam) or has received prior external beam radiation therapy (EBRT) of the head and/or neck.
  • Subject is currently on renal dialysis
  • Subject has started treatment with denosumab < 1 month prior to study entry. Subjects are allowed to be on bisphosphonates or denosumab provided they are on a stable dose for ≥ 4 weeks before administration of study drug
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  • Subject using chronic systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day in the 2 weeks preceding study entry ; replacement doses of steroids, topical, inhalational, nasal and ophthalmic steroids are permitted.
  • Diagnosis of other invasive malignancies within the preceding 3 years prior to screening with > 30% likelihood of relapse within the next 3 years, except non-melanoma skin cancer and non-muscle invasive urothelial cancer
  • Any other serious illness or medical condition or social circumstance that might interfere with the subject's participation in the trial or interfere with the interpretation of the results, including, but not limited to:
  • any uncontrolled infection
  • NYHA Class III or Class IV heart failure
  • unstable angina
  • myocardial infarction within the 6 months prior to study entry
  • uncontrolled hypertension (systolic BP > 160 mmHg despite 2 antihypertensive medications)
  • COPD requiring hospital admission in the year prior to study entry
  • diabetes mellitus requiring hospital admission in the year prior to study entry
  • chronic liver disease
  • hypothyroidism (TSH level > 3.0 mIU/L)
  • substance abuse
  • Unable or unwilling to follow post-therapy radiation protection procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose Ascending Study to Evaluate the Safety and Tolerability of the Therapeutic Radiopharmaceutical 131I-MIP-1095 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The main purpose of this study to determine the safety of an experimental medicine called 131I-MIP-1095. 131I-MIP-1095 is an investigational drug, meaning it has not been approved by the U.S. Food \& Drug Administration (FDA).

Being tested
131I-MIP-1095
Keywords
Radiopharmaceutical (131I-MIP-1095), 16-1110
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 131I-MIP-1095Drug

    First Therapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose.

    2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53

Study groups in NCT03030885
Study groupRoleWhat they receive
131I-MIP-1095ExperimentalFirstTherapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose. 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53
Receives: Drug: 131I-MIP-1095

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    This is a phase 1 dose escalation study of 131I-MIP-1095 in men with metastatic castration-resistant prostate cancer. There are a maximum of five doses under consideration. Dose escalation cohorts will be studied if acceptable toxicity is observed. A dose limiting toxicity is defined as the occurrence of any of the following drug-related toxicities during the first cycle.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2017 (estimated)
  2. Study start19 Jan 2017
  3. Primary completion2 Apr 2019
  4. Study completion2 Apr 2019

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a Phase 1, open-label, single-arm, dose ascending, out-patient study to evaluate the radiopharmaceutical 131I-MIP-1095 in men with mCRPC. The study consists of three phases: Screening, Treatment, and a Follow-up Phase. The Screening Phase consists of subject evaluation for study eligibility and dosimetry assessment. The Treatment Phase consists of two parts: Part 1, dose escalation (Cohorts 1-5), and Part 2, an additional cohort at a selected optimized dose based on safety and efficacy.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030885
Sponsor's protocol ID
16-1110
Status last verified
Apr 2019
First submitted
22 Jan 2017
Last updated
5 Apr 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Laccetti AL, Bodei L, O'Donoghue JA, Weber WA, Morris MJ. A Phase 1, Open-label, Dose-Ascending Study to Evaluate the Safety and Tolerability of the Therapeutic Radiopharmaceutical 131I-MIP-1095 for the Treatment of Metastatic Castration-Resistant Prostate Cancer. Clin Nucl Med. 2023 Nov 1;48(11):937-944. doi: 10.1097/RLU.0000000000004818.

    PubMed 37812518

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 131I-MIP-1095 in people with Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Memorial Sloan Kettering Cancer Center at 1 site 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 25 inclusion and 20 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: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Tolerated Dose (MTD) (time frame: 2 years). 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 NCT03030885, 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 5 Apr 2019.

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