EUCTR2021-001186-20-ES进行中（未招募）1 期
Phase Ib/II multicohort trial of different schemes of PM14 in monotherapy and in combination with radiotherapy in soft tissue sarcomas and other solid tumors - PRIME
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All the cohorts:
- •- The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.
- •- Age: 18-75 years.
- •- Measurable disease according to RECIST v1.1 criteria.
- •- Performance status =1 (ECOG).
- •- Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.
- •- Normal cardiac function with a LVEF = 50% by echocardiogram or MUGA.
- •- HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
- •- Patient must have a central venous catheter for PM14 treatment.
- •Cohorts A, B, E, and F: PM14 monotherapy in advanced disease
- •- Patients must have a diagnosis of soft tissue sarcoma with metastasis, and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis confirmation will be performed and the tumor sample must be available and sent prior to inclusion to this end.
- •- A centralized diagnosis of DD liposarcoma or mixoid/hypercellular liposarcoma or leiomyosarcoma must be confirmed for patients in cohort E.
- •- A centralized diagnosis of other sarcomas includes: undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumors, sarcoma NOS, fibrosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, epithelioid sarcoma, clear cell sarcoma, dedifferentiated or aggressive features in solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, angiosarcoma, epithelioid hemangioendothelioma,
- •- Patients must have received a previous chemotherapy line in advanced disease unless contraindicated or not indicated.
- •- Radiological disease progression must be documented within 6 months prior to study entry.
- •- The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed.
- •Cohort C: Best scheme of PM14 plus RTP in advanced disease
- •- Patients must have a diagnosis of advanced soft tissue sarcoma, or recurrent head & neck suitable for reirradiation or other advanced or metastatic solid tumor not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis will be performed and the tumor sample must be available and sent prior to inclusion to this end. For phase II part, only soft tissue sarcomas will be enrolled.
- •- Patients must have received a previous chemotherapy line in advanced disease.
- •- Disease distribution must allow meeting with normal tissue constrains of radiation therapy. Radiation oncologist must confirm this point at local sites.
- •- Metastatic spread could be present in several organs (i.e. lungs and pelvic fossa) however, not all the loca
排除标准
- •Cohorts A, B, E, and F:
- •1.Performance status = 2 (ECOG).
- •2.Plasma bilirubin > ULN.
- •3.Creatinine > 1.6 mg/dL.
- •4.History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.
- •5.Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.
- •6.Significant cardiovascular disease (for example, dyspnea > 2 NYHA).
- •7.Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.
- •8.Uncontrolled bacterial, mycotic or viral infections.
- •9.Women who are pregnant or breastfeeding.
- •10.Psychological, family, social or geographic circumstances that limit the patients’ ability to comply with the protocol or informed consent.
- •11.Patients participating in another clinical trial or receiving any other investigational product.
- •12.Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
- •13.Histologies other than those described in the inclusion criteria.
- •1.Previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissue constrains).
- •2.Performance status = 2 (ECOG).
- •3.Plasma bilirubin > ULN.
- •4.Creatinine > 1.6 mg/dL.
- •5.History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.
- •6.Severe COPD or other severe pulmonary diseases.
- •7.Significant cardiovascular disease (for example, dyspnea > 2 NYHA).
- •8.Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.
- •9.Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.
- •10.Uncontrolled bacterial, mycotic or viral infections.
- •11.Women who are pregnant or breastfeeding.
- •12.Psychological, family, social or geographic circumstances that limit the patients’ ability to comply with the protocol or informed consent.
- •13.Patients participating in another clinical trial or receiving any other investigational product.
- •14.Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
- •15.Histologies other than those described in inclusion criteria
- •1.High-risk localized patients are not allowed to be enrolled (those G3, deep, and larger than 5 cm or those with risk of death at least 40% by sarculator nomogram).
- •2.Previous treatment with radiotherapy.
- •3.Primary tumor location other than those indicated in the inclusion criteria.
- •4.Histological subtypes other than those indicated in the inclusion criteria.
- •5.Unresectable or inoperable primary tumor.
- •6.Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.
- •7.Performance status = 2 (ECOG).
- •8.Plasma bilirubin > ULN.
- •9.Creatinine > 1.6 mg/dL.
- •10.History of other cancer with less than 5 years free of diseas
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