Clinical trialPhase 1Terminated
Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1b Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
- Outcome
- Stopped early
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 30 July 2015
- Expected end
- 27 April 2016
- Enrollment
- 16 participants
- Sites
- 9
- Primary outcomes
- Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs); Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities; Idelalisib in Combination With Chemotherapy: Percentage of Participants With Dose Limiting Toxicities (DLTs)
- Sponsor
- Industry
- Results posted
- 2021-03-22
- Last update
- 2 April 2021
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Brief summary public domain (ClinicalTrials.gov)
The primary objective of this study is to evaluate the safety of single agent idelalisib and to evaluate safety and define the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) [First dose date up to last dose date (Maximum: 8 weeks) plus 30 days]. Number, percentage of participants. Idelalisib 150 mg (n=12): 100.0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Single-agent IDL: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities [First dose date up to last dose date (Maximum: 8 weeks) plus 30 days]. Number, percentage of participants. Hemoglobin (Hypo), Hematology: Idelalisib 150 mg (n=12): 25.0. Lymphocytes (Hyper), Hematology: Idelalisib 150 mg (n=12): 8.3. Lymphocytes (Hypo), Hematology: Idelalisib 150 mg (n=12): 25.0. Platelets, Hematology: Idelalisib 150 mg (n=12): 8.3. Alanine Aminotransferase, Chemistry: Idelalisib 150 mg (n=12): 58.3. Albumin, Chemistry: Idelalisib 150 mg (n=12): 16.7. Alkaline Phosphatase, Chemistry: Idelalisib 150 mg (n=12): 33.3. Aspartate Aminotransferase, Chemistry: Idelalisib 150 mg (n=12): 66.7. Bilirubin, Chemistry: Idelalisib 150 mg (n=12): 16.7. Creatinine Clearance, Chemistry: Idelalisib 150 mg (n=12): 16.7. Gamma Glutamyl Transferase, Chemistry: Idelalisib 150 mg (n=12): 50.0. Glucose (Hyper), Chemistry: Idelalisib 150 mg (n=12): 16.7. Sodium (Hypo), Chemistry: Idelalisib 150 mg (n=12): 25.0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Idelalisib in Combination With Chemotherapy: Percentage of Participants With Dose Limiting Toxicities (DLTs) [Up to 28 days].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change From Baseline in FoxP3+ and Cluster Determinant 8+ (CD8+) Cells From Tumor Tissue Samples as a Measure of Pharmacodynamics Activity [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Idelalisib Plasma Concentrations Following Idelalisib 150 mg Twice Daily [Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 hours (h) postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose]. Median, ng/mL (Inter-Quartile Range). Cycle 1; Day 1 (Predose): Idelalisib 150 mg (n=12): NA (NA to NA) [The plasma concentration of IDL was below the limit of quantitation.]. Cycle 1; Day 1 (0.5 h): Idelalisib 150 mg (n=12): 1110 (13.90 to 3220). Cycle 1; Day 1 (1 h): Idelalisib 150 mg (n=12): 1880 (39.10 to 4060). Cycle 1; Day 1 (1.5 h): Idelalisib 150 mg (n=12): 1690 (318 to 2260). Cycle 1; Day 1 (2 h): Idelalisib 150 mg (n=12): 1290 (173 to 4460). Cycle 1; Day 1 (3 h): Idelalisib 150 mg (n=12): 795 (631 to 2870). Cycle 1; Day 1 (4 h): Idelalisib 150 mg (n=12): 1540 (519 to 1990). Cycle 1; Day 1 (8 h): Idelalisib 150 mg (n=12): 251 (134 to 753). Cycle 1; Day 8 (Predose): Idelalisib 150 mg (n=12): 264 (208 to 501.5). Cycle 1; Day 8 (1.5 h): Idelalisib 150 mg (n=12): 2050 (1335 to 2620). Cycle 1; Day 15 (Predose): Idelalisib 150 mg (n=12): 275 (241 to 1120). Cycle 1; Day 15 (1.5 h): Idelalisib 150 mg (n=12): 1605 (1170 to 2130). Cycle 2; Day 1 (Predose): Idelalisib 150 mg (n=12): 178.05 (39.05 to 281). Cycle 2; Day 1 (1.5 h): Idelalisib 150 mg (n=12): 2180 (1825 to 3095).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Idelalisib Metabolite (GS-563117) Plasma Concentrations Following Idelalisib 150 mg Twice Daily [Cycle 1, Day 1: Predose and 0.5, 1, 1.5, 2, 3, 4, and 8 h postdose; Day 8: Predose and 1.5 h postdose; Day 15: Predose and 1.5 h postdose Cycle 2, Day 1: Predose and 1.5 h postdose]. Median, ng/mL (Inter-Quartile Range). Cycle 1; Day 1 (Predose): Idelalisib 150 mg (n=12): NA (NA to NA) [The plasma concentration of GS-563117 was below the limit of quantitation.]. Cycle 1; Day 1 (0.5 h): Idelalisib 150 mg (n=12): 173 (NA to 220) [The plasma concentration of GS-563117 was below the limit of quantitation.]. Cycle 1; Day 1 (1 h): Idelalisib 150 mg (n=12): 1220 (16.70 to 1460). Cycle 1; Day 1 (1.5 h): Idelalisib 150 mg (n=12): 1070 (141 to 1930). Cycle 1; Day 1 (2 h): Idelalisib 150 mg (n=12): 1700 (106 to 4430). Cycle 1; Day 1 (3 h): Idelalisib 150 mg (n=12): 1580 (190 to 5980). Cycle 1; Day 1 (4 h): Idelalisib 150 mg (n=12): 1370 (849 to 5960). Cycle 1; Day 1 (8 h): Idelalisib 150 mg (n=12): 632 (619 to 5340). Cycle 1; Day 8 (Predose): Idelalisib 150 mg (n=12): 2175 (1385 to 5790). Cycle 1; Day 8 (1.5 h): Idelalisib 150 mg (n=12): 2775 (1765 to 5725). Cycle 1; Day 15 (Predose): Idelalisib 150 mg (n=12): 2130 (1020 to 6800). Cycle 1; Day 15 (1.5 h): Idelalisib 150 mg (n=12): 2890 (2010 to 4815). Cycle 2; Day 1 (Predose): Idelalisib 150 mg (n=12): 1046.5 (490.34 to 1360). Cycle 2; Day 1 (1.5 h): Idelalisib 150 mg (n=12): 1405 (1325 to 2305).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate (ORR) [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [Up to 2 years].