Phase 2
Completed N=18
A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov NCT00842335 ↗Enrolled (actual)
18
Serious AEs
33.3%
Results posted
Jun 2013
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of JI-101 — 400 mg
Summary
The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor metabolism will also be studied. JI-101 is an inhibitor of new blood vessel growth that may provide benefit to patients with solid tumors that have failed standard therapeutic regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of JI-101 |
400 | — |
| SECONDARY Number of Participants Reaching Maximum Tolerated Dose |
18 | — |
| SECONDARY Overall Clinical Response by Cycle |
7; 10; 5; 2; 5; 0 | — |
| SECONDARY Days to Progression |
55 | — |
Eligibility Criteria
Inclusion Criteria
- Be 18 years of age or greater at the time of consent.
- Have solid tumors for which no approved therapy or standard of care is available or have solid tumors and have failed standard-of-care therapy.
- Have life expectancy of greater than 3 months.
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Have organ and marrow function as defined below:
- absolute neutrophil count ≥ 1.5 x 10^9 cells/L
- hemoglobin ≥ 9.0 g/dL
- platelets ≥ 75 x 10^9 cells/L
- total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for liver metastases)
- serum creatinine 2+ protein on urine dipstick) at baseline should undergo a 24-hour urine collection. Results must demonstrate <500 mg of protein in 24 hours to allow participation in the study)
- Patients with any of the following contraindications to FDG-PET can participate in the study if all of the inclusion criteria and none of the exclusion criteria are met, but these patients are excluded from FDG PET assessments:
o Inability to remain lying down in PET scanner (for PET portion of the study).
- Absence of at least one metastatic lesion greater than or equal to 2 cm on pre-dose CT (computed tomography) scan or other radiographic imaging as defined by response evaluation criteria in solid tumors (RECIST) criteria.
Data sourced from ClinicalTrials.gov (NCT00842335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.