Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, … (NCT04276597) | Clinical Trial Compass
WithdrawnPhase 2
Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.
Stopped: No subjects were eligible for the study. The study closed on 07-15-2021.
United States0Started 2020-03-04
Plain-language 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.
The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* 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).
* 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-bearin…
What they're measuring
1
Assessment of the overall response rate
Timeframe: 12 monts
Trial details
NCT IDNCT04276597
SponsorExcel Diagnostics and Nuclear Oncology Center