A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00842335|
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: JI-101||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2009|
|Primary Completion Date :||July 2010|
|Study Completion Date :||January 2012|
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
- Maximum Tolerated Dose (MTD) of JI-101 [ Time Frame: 28 days (1 cycle) ]
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Up to 112 days (up to four 28-day cycles) or longer if the patient is benefiting from treatment ]Number of participants withdrawn from study due to adverse events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) ]
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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842335
|United States, Arizona|
|Premiere Oncology of Arizona|
|Scottsdale, Arizona, United States, 85258|