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Pulmonary Neuroendocrine NeoplasmPhase 2PUTNETNCT04276597

Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.

A Phase 2 study testing 177Lu-DOTATOC in people with Pulmonary Neuroendocrine Neoplasm and Pheochromocytoma, run by Excel Diagnostics and Nuclear Oncology Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
177Lu-DOTATOC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
4 Mar 2020to 15 Jul 2021
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Subjects of either sex, aged ≥18 years.
  • ECOG status 0-2.
  • Life-expectancy of at least 12 weeks.
  • Histologically/cytologically confirmed diagnosis of SSTR (+) neuroendocrine tumors of the lung, Pheochromocytoma, Paraganglioma, thymus, and unknown primary, unresectable or metastatic.
  • Measurable disease per RECIST 1.1, on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter (lymph nodes along short axis >15 mm).
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  • Appropriate diagnostic imaging studies, at the discretion of the P.I. including but not limited to CT, MRI , 18F-FDG PET/CT, NAF PET/CT bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day.
  • Somatostatin receptor positive (SSTR+) disease, as evidenced by available FDA, commercially of IND approved SSTR imaging (SRI), within 4 weeks prior to the first cycle
  • Recent blood test results (within 2weeks pre-dose) as follows:
  • Sufficient bone marrow capacity as defined by WBC ≥2,500/µl and WBC≥2,000/mm3 for subsequent cycles; platelets ≥ 100,000 (100 * 103/mm3) for the first treatment and ≥75,000 for the subsequent therapies, Hgb ≥8.9 g/dl for the first treatment and 8.0 g/dl for the subsequent therapies, ANC ≥1500/mm3 for the first treatment and ≥1000/ mm3; for the subsequent therapies.
  • ALT, AST values ≤3 times ULN
  • Bilirubin: ≤3 times ULN
  • Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dl
  • Negative pregnancy test in women capable of child-bearing within 48 hours of IMP administration.
  • Serum albumin > 3.0g/L (<3 g/L may be acceptable at the discretion of investigator, if PT, PTT, and INR are within normal range)
  • All available FDA-approved therapies for which the subject is eligible have been exhausted (with the exception of PRRT), unless available therapies are refused by the subject (with the exception of somatostatin analogue, octreotide, and somatuline).

Who cannot join

  • Known hypersensitivity to any of the excipients of Lu-177 DOTATOC.
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to treatment.
  • Subjects with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up
  • Any subject who is taking concomitant medications that decrease renal function (such as aminoglycoside antibiotics).
  • Female subjects who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 67 days (more than 10 half-lives of 177Lu after the last treatment, or male subjects who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 67 days after the last treatment.
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
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  • Indication for surgical lesion removal with curative potential
  • Planned (for the period of study participation): chemotherapy, immunotherapy, radiation therapy (unless regional for pain relief) chemo-embolization, bland embolization, radio-embolization, treatment with cyclosporine-A.
  • Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrolment
  • Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biological agent for less than 5 half-lives; and (3) radiation therapy (except regional for pain relief) for less than 6 weeks prior to study enrolment,
  • Uncontrolled congestive heart failure; subjects suspected of having this condition need to show ejection fraction of > 35% as determined by MUGA scan.
  • Glomerular Filtration Rate (GFR) < 35 mL/min
  • Subjects with prior peptide receptor radionuclide therapy (PPRT).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texas, 77042

Other trials in United States

About this study

Official title: A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.

The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Being tested
177Lu-DOTATOC
Keywords
Neuroendocrine tumors, Thymus neuroendocrine, Unknown Primary, Paraganglioma, Pheochromocytoma, Pulmonary, Any other non-.GEP-NET, NET
Medical subject headings
Pheochromocytoma, Paraganglioma, Neoplasms, Unknown Primary, Neuroendocrine Tumors, Carcinoma, Merkel Cell

What participants receive

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

  • 177Lu-DOTATOCDrug

    177Lu labeled somatostatin receptors targeting ligand

Study groups in NCT04276597
Study groupRoleWhat they receive
Lu177 DOTATOC treatmentExperimental4 doses of 200mCi 177Lu- DOTATOC PRRT
Receives: Drug: 177Lu-DOTATOC

What is being measured

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

  1. Assessment of the overall response rate

    determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

    Measured: 12 monts

Secondary outcomes (1)

  1. Progression Free Survival (rPFS) in subjects receiving 4 cycles of therapy Monitoring of the changes in quality of life (QOL) through assessment of ECOG performance status and a QOL subject questionnaire.

    determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

    Measured: 12 months

Timeline

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

  1. First posted19 Feb 2020
  2. Study start4 Mar 2020
  3. Primary completion15 Jul 2021
  4. Study completion15 Jul 2021

Why it stopped: No subjects were eligible for the study. The study closed on 07-15-2021.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04276597
Sponsor's protocol ID
143631
Acronym
PUTNET
Status last verified
Mar 2023
First submitted
14 Feb 2020
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-DOTATOC in people with Pulmonary Neuroendocrine Neoplasm and Pheochromocytoma, run by Excel Diagnostics and Nuclear Oncology 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 16 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 Mar 2023. 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Assessment of the overall response rate (time frame: 12 monts). 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 NCT04276597.

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 10 Mar 2023.

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