A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 158
- 试验地点
- 24
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18 years or older with histologically confirmed metastatic pancreatic ductal adenocarcinoma or poorly differentiated carcinoma.
- •Measurable disease according to RECIST 1.
- •Archival tumour tissue for tertiary correlative studies (biopsy or resection of primary or metastasis). Fine needle aspirate (FNA) or brushings will not be accepted.
- •ECOG performance of 0-1 (Appendix 2)
- •Adequate renal and haematological function
- •Adequate hepatic function, defined as:
- •Bilirubin <1.5 X ULN (Upper Limit of Normal), AST or ALT ≤ 5x ULN. If a person was recently stented with improving bilirubin, the person can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.
- •Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- •Study treatment both planned and able to start within 7 days after randomisation
- •Signed, written informed consent.
排除标准
- •Uncontrolled metastatic disease to the central nervous system. To be eligible, known CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time.
- •Prior chemotherapy or investigational anti-cancer therapy for metastatic pancreatic adenocarcinoma. Prior treatments with curative intent or for locally advanced disease are allowed, provided the last dose of chemotherapy was administered more than 6 months prior to randomisation.
- •Prior radiotherapy or major surgery (as defined by local investigator) within 14 days of starting treatment.
- •Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anti-cancer therapy with the exception of alopecia, vitiligo and the laboratory values defined in the inclusion criteria. Participants with Grade ≥2 peripheral neuropathy are not allowed.
- •Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy or biological agents.
- •Known allergy or hypersensitivity to any of the study drugs and excipients.
- •Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
- •History of prior or synchronous malignancy within 2 years prior to randomisation, except:
- •Malignancy that was treated with curative intent and for which there has been no known active disease for ≥2 years prior to randomisation.
- •Curatively treated non-melanoma skin cancer, cervical cancer in situ, superficial transitional cell carcinoma of the bladder, stage 1 endometrial carcinoma, prostatic intraepithelial neoplasia, low-grade papillary thyroid cancer, untreated localised very low risk or low risk prostate cancer under observation.
- •Concurrent illness, including severe infection that may jeopardise the ability of the person to undergo the procedures outlined in this protocol with reasonable safety.
- •Neuroendocrine pancreatic carcinoma.
- •Life expectancy of less than 3 months.
- •Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception.
- •Serious medical or psychiatric conditions that might limit the ability of the person to comply with the protocol.
研究组 & 干预措施
Cohort A: Standard Care + LSTA1 (1 dose)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: LSTA1 (Drug)
Cohort A: Standard Care + LSTA1 (1 dose)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Gemcitabine Injection (Drug)
Cohort A: Standard Care + LSTA1 (1 dose)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Nab paclitaxel (Drug)
Cohort A: Standard Care + Placebo
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Gemcitabine Injection (Drug)
Cohort A: Standard Care + Placebo
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Nab paclitaxel (Drug)
Cohort B: Standard Care +LSTA1 (2 doses)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: LSTA1 (Drug)
Cohort B: Standard Care +LSTA1 (2 doses)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Gemcitabine Injection (Drug)
Cohort B: Standard Care +LSTA1 (2 doses)
Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Nab paclitaxel (Drug)
Cohort B: Standard Care + Placebo
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; Gemcitabine 1000mg/m2, and then +~4hrs matching placebo IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Gemcitabine Injection (Drug)
Cohort B: Standard Care + Placebo
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; Gemcitabine 1000mg/m2, and then +~4hrs matching placebo IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
干预措施: Nab paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: From date of randomization to 18 months later, or death
Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
次要结局
- Overall Survival(From date of randomization to 18 months later, or death)
- Objective Tumour Response Rate(From date of randomization to 18 months later, or death)
- Patient-reported Outcomes(Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).)
- Incidence of Treatment-Emergent Adverse Events (Patient Safety)(From date of randomization until 30 days after final treatment visit)