A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
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|ClinicalTrials.gov Identifier: NCT02509039|
Recruitment Status : Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin||Drug: CC-122||Phase 1|
This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the safety, tolerability, (Pharmacokinetics) PK, and preliminary efficacy of CC-122 in Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL).
Subjects will receive ascending dose levels of CC-122 from Cycle 1 onwards to measure PK and to determine safety and tolerability.
An initial cohort of at least three subjects will be given CC-122 at a dose of 2.0 mg on an intermittent dosing schedule (5 continuous days out of 7 days per week) and 3-6 subjects will be enrolled in subsequent dose levels. Dose escalation for subsequent cohorts will proceed according to a standard dose escalation design (3+3 design) (Storer, 1989) to establish initial toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Multi-center, Open-label Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of CC-122 Administered Orally to Adult Japanese Subjects With Advanced Solid Tumors or Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||September 2, 2015|
|Actual Primary Completion Date :||March 30, 2017|
|Estimated Study Completion Date :||December 31, 2019|
CC-122 is administered orally, on a 5 continuous days out of 7 days per week intermittent dosing schedule.
5 continuous days out of 7 days per week intermittent dosing
- Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 2 weeks ]Number of participants with a DLT
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 4weeks ]The last dose level with 0 or 1 out of 6 subjects experiencing Dose Limiting Toxicities (DLTs) during the DLT evaluation period.
- Adverse Events (AEs) [ Time Frame: Apprximately 6 months ]Number of participants with adverse events
- Pharmacokinetics -AUC [ Time Frame: Apprximately 2 weeks ]Area under the plasma concentration time-curve
- Pharmacokinetics - Cmax [ Time Frame: Apprximately 2 weeks ]Peak (maximum) plasma concentration
- Pharmacokinetics - t1/2 [ Time Frame: Apprximately 2 weeks ]Terminal half-life of (t1/2)
- Pharmacokinetics - Tmax [ Time Frame: Apprximately 2 weeks ]Time to maximum plasma concentration (Tmax).
- Pharmacokinetics - CL/F [ Time Frame: Apprximately 2 weeks ]Apparent clearance
- Pharmacokinetics - Vz/F [ Time Frame: Apprximately 2 weeks ]Apparent volume of distribution
- Antitumor activity [ Time Frame: Apprximately 6 months ]Antitumor efficacy, determined by response rates in each tumor type using appropriate tumor response criteria, and duration of response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509039
|Aichi Cancer Center Hospital|
|Nagoya-shi, Aichi, Japan, 464-8681:|
|National Cancer Center Hospital East|
|Kashiwa-shi, Chiba, Japan, 277-8577|
|Niigata Cancer Center Hospital|
|Niigata-shi, Niigata, Japan, 951-8566|
|The Cancer Institute Hospital of Japanese Foundation For Cancer Research|
|Koto-ku, Tokyo, Japan, 135-8550|
|Study Director:||Sasaki Toru||Celgene|