Clinical trialPhase 1 / Phase 2Terminated
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors
A Phase I/II Study of X-82, an Oral Anti-VEGFR Tyrosine Kinase Inhibitor, With Everolimus for Patients With Pancreatic Neuroendocrine Tumors
- Outcome
- Stopped earlyPharmaceutical company decision (Business decision)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 3 May 2013
- Expected end
- 19 August 2020
- Enrollment
- 23 participants
- Sites
- 2
- Primary outcomes
- Number of Participants With Dose Limiting Toxicities - Phase I; Overall Toxicities - Phase I; Recommended Phase II Dose of X-82; Objective Response Rate (Complete Response + Partial Response) - Phase II
- Sponsor
- Other
- Results posted
- 2021-06-10
- Last update
- 8 July 2021
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Brief summary public domain (ClinicalTrials.gov)
This study is to evaluate the combination of an investigational drug X-82 with everolimus in the treatment of pancreatic neuroendocrine tumors.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Dose Limiting Toxicities - Phase I [Completion of 1st cycle for all patients in Phase I portion of study (completed in approximately 20 months)]. Count Of Participants, Participants. Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 0; Phase I Dose Level 2: X-82 + Everolimus (n=3): 0; Phase I Dose Level 3: X-82 + Everolimus (n=6): 1; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Toxicities - Phase I [30 days after completion of treatment (estimated to be 13 months)]. Count Of Participants, Participants. Anemia: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 1; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 1; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Hearing impaired: Phase I Dose Level 0: X-82 + Everolimus (n=3): 1; Phase I Dose Level 1: X-82 + Everolimus (n=3): 0; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 0; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Peripheral vision/depth perception impairment: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 1; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 0; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Abdominal distension: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 1; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 0; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Abdominal pain: Phase I Dose Level 0: X-82 + Everolimus (n=3): 1; Phase I Dose Level 1: X-82 + Everolimus (n=3): 0; Phase I Dose Level 2: X-82 + Everolimus (n=4): 1; Phase I Dose Level 3: X-82 + Everolimus (n=8): 5; Phase I Dose Level 4: X-82 + Everolimus (n=3): 2. Colonic fistula: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 0; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 1; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Constipation: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 1; Phase I Dose Level 2: X-82 + Everolimus (n=4): 1; Phase I Dose Level 3: X-82 + Everolimus (n=8): 1; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Diarrhea: Phase I Dose Level 0: X-82 + Everolimus (n=3): 2; Phase I Dose Level 1: X-82 + Everolimus (n=3): 2; Phase I Dose Level 2: X-82 + Everolimus (n=4): 2; Phase I Dose Level 3: X-82 + Everolimus (n=8): 3; Phase I Dose Level 4: X-82 + Everolimus (n=3): 2. Dry mouth: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 0; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 2; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Dyspepsia: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 1; Phase I Dose Level 2: X-82 + Everolimus (n=4): 0; Phase I Dose Level 3: X-82 + Everolimus (n=8): 0; Phase I Dose Level 4: X-82 + Everolimus (n=3): 0. Flatulence: Phase I Dose Level 0: X-82 + Everolimus (n=3): 0; Phase I Dose Level 1: X-82 + Everolimus (n=3): 0; Phase I Dose Level 2: X-82 + Everolimus (n=4): 1; Phase I Dose Level 3: X-82 +
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Recommended Phase II Dose of X-82 [Completion of 1st cycle for all patients in Phase I portion of study (completed in approximately 20 months)]. Number, mg. Phase I All Dose Levels: X-82 + Everolimus (n=21): 300.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (Complete Response + Partial Response) - Phase II [Through completion of treatment (estimated to be 12 months)]. Count Of Participants, Participants. Phase II: X-82 + Everolimus (n=1): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Stabilization Rate - Phase II [Through completion of treatment (estimated to be 12 months)]. Count Of Participants, Participants. Phase II: X-82 + Everolimus (n=1): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) - Phase II [Up to 3 years]. Median, days (Full Range). Phase II: X-82 + Everolimus (n=2): 183 (174 to 192).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival - Phase II [Up to 3 years]. Median, days (Full Range). Phase II: X-82 + Everolimus (n=2): 115 (94 to 136).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Toxicity - Phase II [Through 30 days after completion of treatment (estimated to be 13 months)]. Count Of Participants, Participants. Diarrhea: Phase II: X-82 + Everolimus (n=2): 2. Mucositis oral: Phase II: X-82 + Everolimus (n=2): 1. Nausea: Phase II: X-82 + Everolimus (n=2): 1. Vomiting: Phase II: X-82 + Everolimus (n=2): 1. Chest pain: Phase II: X-82 + Everolimus (n=2): 1. Edema limbs: Phase II: X-82 + Everolimus (n=2): 1. Hematoma: Phase II: X-82 + Everolimus (n=2): 1. Mouth sores: Phase II: X-82 + Everolimus (n=2): 1. Creatinine increased: Phase II: X-82 + Everolimus (n=2): 1. Platelet count decreased: Phase II: X-82 + Everolimus (n=2): 1. Hip pain: Phase II: X-82 + Everolimus (n=2): 1. Leg cramps: Phase II: X-82 + Everolimus (n=2): 1. Dizziness: Phase II: X-82 + Everolimus (n=2): 1. Headache: Phase II: X-82 + Everolimus (n=2): 1. Allergic rhinitis: Phase II: X-82 + Everolimus (n=2): 1. Rash acneiform: Phase II: X-82 + Everolimus (n=2): 1. Rash maculo-papular: Phase II: X-82 + Everolimus (n=2): 1. Hypertension: Phase II: X-82 + Everolimus (n=2): 1.