A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, an Oral Angiogenesis Inhibitor, in Patients With Advanced Solid Tumors|
- Maximum Tolerated Dose (MTD) of JI-101 [ Time Frame: 28 days (1 cycle) ] [ Designated as safety issue: Yes ]
The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors.
The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD.
Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacceptable treatment-related toxicity was defined as a clinically significant AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and that was attributed to JI 101.
- Number of Participants Reaching Maximum Tolerated Dose [ Time Frame: Up to 112 days (up to four 28-day cycles) or longer if the patient is benefiting from treatment ] [ Designated as safety issue: Yes ]Number of participants withdrawn from study due to adverse events
- Overall Clinical Response by Cycle [ Time Frame: Up to 112 days ( four 28-day cycles) ] [ Designated as safety issue: No ]
Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions
- Days to Progression [ Time Frame: Up to 112 days (four 28-day cycles) or longer if the patient is benefiting from treatment ] [ Designated as safety issue: No ]Progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions
|Study Start Date:||February 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842335
|United States, Arizona|
|Premiere Oncology of Arizona|
|Scottsdale, Arizona, United States, 85258|