CTRI/2023/10/059269尚未招募2 期
An Investigator Initiated Open label pilot study to evaluate the safety and efficacy of 212Pb-VMT-a-peptide in subjects with Somatostatin Receptor Expressing Neuroendocrine Tumors
B J Madan and Company0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Male or female =18 years old with unresectable or metastatic histologically confirmed NET
- •2) Documented progression of disease following previous therapy within 12 months prior to enrollment and the presence of at least 1 site of measurable disease per RECIST 1.1;
- •3) Subjects must have received and progressed following somatostatin analog administration.
- •4) Confirmed presence of somatostatin receptors on all lesions including the non-target and measurable lesions documented by CT/MRI scans, based on positive 68Ga- DOTANOC or Pb203-VMT-a-peptide SSTR PET/CT imaging within 6 weeks prior to enrollment. Follow up imaging will be performed with the same agent or modality used at baseline;
- •5) Target lesions must be positive (greater than grade 2 uptake Krenning Score) or must have an SUV of more than the normal liver background.
- •6) Lytic bone lesions, with an identifiable soft tissue component, evaluated by CT or MRI, can also be considered measurable lesions if the soft tissue component otherwise meets the definition of measurability according to RECIST 1.1. In any case, osteoblastic bone lesions are not measurable.
- •7) Eastern Cooperative Oncology Group (ECOG) status 0-2.
- •8) Life expectancy of at least 12 weeks in the opinion of the investigator at the time of screening;
- •9) 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- VMT-a-peptide.
- •10) Sufficient bone marrow capacity and organ function in the recent blood tests within 3 weeks prior to Day 1, as defined by:
- •a) White blood cell (WBC) =2,500/ mm3;
- •b) Absolute neutrophil count (ANC) =1000/mm3;
- •c) Platelets =100,000/mm3;
- •d) Hemoglobin (HgB) =9.0 g/dL;
- •e) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) =3 X upper limit of normal (ULN);
- •f) Total Bilirubin: =2 X ULN;
- •g) Serum creatinine =1.7 mg/dL;
- •h) Serum albumin =3.0 g/L; if lower than 3.0 g/L requires normal range prothrombin time (PT) and international normalized ratio (INR)
排除标准
- •1) Prior whole-body radiotherapy or PRRT using 177Lu/90Y/111In-DOTATATE/ DOTATOC or TAT.
- •2) Prior regional hepatic radionuclide therapy within 4 months prior to enrollment or prior nonradioactive regional hepatic therapy within 6 months prior to enrollment.
- •3) Known hypersensitivity to somatostatin analogues, AA infusion, or 212Pb-VMT-a-peptide;
- •4) Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to administration of study drug;
- •5) History of myelodysplastic syndrome (MDS);
- •6) Female subjects who are pregnant or lactating;
- •7) Indication for surgical lesion removal with curative potential;
- •8) Known brain metastases, unless these metastases have been treated and/or stable for 6 months prior to enrollment;
- •9) Experimental cancer treatments or other investigational therapies within 6 weeks or five half-lives of the investigational medication prior to Day 1;
- •10) Uncontrolled congestive heart failure (NYHA II, III, IV);
- •11) Uncontrolled diabetes mellitus as defined by a hemoglobin A1C >10.0;
- •12) Evidence of renal obstruction based on Tc-99m DTPA or TER for MAG3 renal scintigraphy or renal ultrasound.
- •13) Known or active human immunodeficiency virus (HIV) or hepatitis B or C virus unless cured;
- •14) Known or suspected active drug or alcohol abuse;
- •15) Participation in other interventional clinical studies within 30 days prior to Day 1;
- •16 Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years;
- •16) Any somatic or psychiatric disease/condition or abnormal laboratory test that in the opinion of the investigator, may interfere with the objectives and assessments of the study; or
- •17) Unable to comply with the requirements of the study protocol or be unsuitable for the study for any reason, in the opinion of the investigator.
研究者
相似试验
进行中（未招募）
1 期
Trial to investigate which atopic dermatitis patients will respond to the biologic therapy tralokinumabAtopic DermatitisEUCTR2020-005976-36-SEKarolinska Universitetssjukhuset42
已完成
不适用
A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle relaxation & low back pain in two different populations.ow Back Pain > 3 WeeksACTRN12617000362392dorsaVi Ltd.40
进行中（未招募）
1 期
An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment with the BTK Inhibitor PRN1008 in Patients with Newly Diagnosed or Relapsing Pemphigus VulgarisPemphigus: Pemphigus VulgarisMedDRA version: 20.0Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858EUCTR2015-003564-37-HRPrincipia Biopharma Australia Pty Ltd42
进行中（未招募）
1 期
A Pilot Study Investigating the Safety, Clinical Activity, Drug Levels, and Effects on PRN 1008 in Patients with Newly Diagnosed or Relapsing Pemphigus VulgarisPemphigus: Pemphigus VulgarisMedDRA version: 18.1Level: LLTClassification code 10052802Term: Pemphigus vulgarisSystem Organ Class: 100000004858EUCTR2015-003564-37-GRPrincipia Biopharma Australia Pty Ltd25
进行中（未招募）
1 期
open label, randomized, pilot study on the activity of olanzapine with or without delayed dexamenthasone versus dexamenthasone alone for the prevention of delayed nausea and vomiting in patients with gynecologic cancers receiving carboplatin and paclitaxel-based chemotherapy and guidline-directed prophylactic anti-emeticsPatients with gynecologic tumors candidate to chemotherapy with carboplatinum and paclitaxelEUCTR2013-005309-30-ITFondazione IRCCS Istituto Nazionale dei Tumori75