EUCTR2022-003016-87-SK进行中（未招募）1 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDYTO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 168
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
- 性别
- All
入选标准
- •1. Participants aged =18 years (or the minimum age of consent if >18 in accordance with local regulations) at Screening who have signed informed consent.
- •a. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding.
- •b. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- •Disease Characteristics:
- •2.Documented histologic or cytologic active diagnosis of NSCLC, PANC, or CRC and are currently receiving, or have completed, SOC treatment for this cancer (which may include systemic therapy).
- •3.Cachexia defined by Fearon criteria of weight loss as (See Section 8.1.1 for details if the participant’s body weight is unavailable from medical record):
- •- BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to
- •- involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI.
- •4. Serum GDF-15 concentrations of =1.5 ng/mL (as measured using the Investigational Use Only Roche Elecsys GDF 15 assay)10 at Screening.
- •5.Participants who are assessed by the investigator to have:
- •- an ECOG PS =3, and,
- •- a life expectancy of at least 4 months to be able to complete Part A.
- •Other Inclusion Criteria:
- •6. Participants who are willing and able to comply with all scheduled visits, treatment
- •plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 101
排除标准
- •Medical Conditions:
- •1. Current active reversible causes of decreased food intake, as determined by the Investigator. These causes may include, but are not limited to:
- •- NCI CTCAE Grade 3 or 4 oral mucositis;
- •- NCI CTCAE Grade 3 or 4 GI disorders (nausea, vomiting, diarrhea, and
- •constipation);
- •- Mechanical obstructions interfering with the participant's ability to eat.
- •2. Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.
- •3. Cachexia caused by other reasons, as determined by the investigator, including, but not limited to:
- •- Severe COPD requiring use of home O2;
- •- NYHA class III-IV heart failure;
- •4. Undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must have recovered from acute effects of surgery prior to Screening. Patient should not have plans to undergo major surgical procedures during the study.
- •5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •6. History of allergic or anaphylactic reaction to any therapeutic or diagnostic
- •monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody.
- •Prior/Concurrent Therapy:
- •7.Current use of any prohibited concomitant medication(s) within 4 weeks prior to first dose of study intervention. Refer to Section 6.9.
- •Prior/Concurrent Clinical Study Experience:
- •8.Concurrent administration of investigational products (including drug, biologic agents, or vaccines) are not permitted within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) of the first dose of study intervention. Refer to Section 6.9.
- •9.Enrollment and previously dosed in a prior study with ponsegromab.
- •Diagnostic Assessments:
- •10.History of severe liver disease or cirrhosis, unrelated to metastatic cancer. Potential study participants with the following liver function test abnormalities will also be excluded; result may be confirmed by a single repeat test, if necessary:
- •- Total bilirubin =1.5 × ULN (except for Gilbert's syndrome)
- •- AST >3 × ULN (AST > 5X ULN if there is liver involvement by the tumor)
- •- ALT >3 × ULN (ALT >5X ULN if there is liver involvement by the tumor)
- •- Alkaline phosphatase >3 x ULN (Alkaline phosphatase >5X ULN if there is liver involvement by the tumor and/or in case of bone metastases, or if considered related to prior surgery e.g. pancreaticoduodenectomy).
- •11.Renal disease requiring dialysis.
- •Other Exclusion Criteria:
- •12.Current adherence to a calorie-restricted diet with the intention weight loss.
- •13.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
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