Clinical Trials List
2025-11-11 - 2030-12-31
Phase II/III
Not yet recruiting5
ICD-10R64
Cachexia
ICD-9799.4
Cachexia
A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Hsiang-Fong Kao 無
- WEI-LI MA 無
- Chih-Hung Hsu 無
- Ann-Lii Cheng 無
- 呂理駿 無
- YU-YUN SHAO 無
- TSUNG-HAO LIU 無
- SHIH-HUNG YANG 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 吳柏宣 無
- Jeng-Shiun Du 無
- Yi-Hsun Chen 無
- Shih-Chang Chuang 無
- Tsung-Jang Yeh 無
- Hui-Ching Wang 無
- I-CHEN WU 無
- 謝子禹 無
- Wang Yao-Kuang 無
- 王閔宏 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Hung-Yuan Yu 無
- Yi-Ping Hung 無
- 李癸汌 無
- 姜乃榕 無
- Ming-Huang Chen 無
- Shao-Jung Hsu 無
- 唐振育 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chi-Ching Chen 無
- 王秀慈 無
- 鄭富銘 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Change in FAACT-5IASS subscale scores since baseline at week 12
Inclution Criteria
Signed Informed Consent Document
Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
Cachexia defined by Fearon criteria of weight loss
Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
ECOG PS ≤1 with life expectancy of at least 4 months
Exclusion Criteria
Current active reversible causes of decreased food intake
Cachexia caused by other reasons
History of heart failure
Left ventricular ejection fraction <50%
Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
Inadequate liver function
Renal disease requiring dialysis or eGFR <30 mL/min/1.73m2
The Estimated Number of Participants
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Taiwan
55 participants
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Global
982 participants
