Phase I Study of KPT330 in Asian Patients
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|ClinicalTrials.gov Identifier: NCT02078349|
Recruitment Status : Recruiting
First Posted : March 5, 2014
Last Update Posted : June 22, 2016
This is an open-label, dose-escalation (Phase 1a) and expansion (Phase 1b) study to evaluate the safety and tolerability of KPT-330 and determine the recommended phase 2 dose (RP2D) in patients with solid tumor malignancies. The study drug KPT-330 or Selinexor works by blocking high levels of exporter proteins in cancer cells so that the tumor suppressor proteins (TSP, proteins that help to protect cells from becoming cancerous) and growth regulatory proteins (GRP, proteins that help control the growth of cells) will remain in the nucleus in its "activated" form. The idea for using this drug is that the blockage of this export of proteins from the nucleus should result in stopping the growth of tumor cells. Based on its mechanism of action, KPT-330 is a new class of drug called Selective Inhibitor of Nuclear Export (SINE).
The purposes of this research study are to find out more information about the drug such as: the highest dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the body affects the study drug concentrations in the blood (called pharmacokinetics or PK), to examine the effects of this study drug on the body (called pharmacodynamics or PD) and to gain some information on its usefulness in treating cancer.
Benefits of the study include the chance of disease control for patients with treatment refractory cancer for which no other standard treatments are available. Common side effects (35-73%) in humans have mostly been mild and reversible. These include nausea, loss of appetite, fatigue, vomiting and weight loss.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: KPT-330||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigator Sponsored Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses Followed by Dose Expansion of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Asian Patients With Advanced or Metastatic Solid Tumor Malignancies|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Solid Tumors
Patients will receive Selinexor once weekly (Schedule 1) or twice weekly (Schedule 2) or three times a week (Schedule 3) orally at a starting dose of 50 mg/m² (Schedule 1) and 40mg/m2 (Schedule 2) and 20mg/m2 (Schedule 3).
One cycle is 28 days for Schedule 1 and Schedule 3 and 21 days for Schedule 2. Treatment will continue until disease progression or the development of unacceptable toxicities.
Each dose will consist of KPT-330 (Selinexor) for oral administration on an mg/m2 basis, and should be based on the patient's actual calculated body surface area (BSA) at baseline. Patients with a BSA >2.5 m(2) will receive a dose based upon a 2.5 m(2) BSA.
Other Name: Selinexor
- Number of participants with Adverse Events [ Time Frame: up to 12 months ]All adverse events occurring during the course of the trial and for up to one month after the last dose of study medication will be captured, documented, and reported. Toxicity is graded every 2 weeks for the first two cycles and every 4 weeks thereafter, according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Time to reach Cmax (Peak Plasma Concentration) of KPT-330 (Selinexor) [ Time Frame: 2 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078349
|Contact: Boon Cher Goh, MBBS||(65) 6772 4140/ 6772 4621||Boon_Cher_Goh@nuhs.edu.sg|
|Contact: David S Tan, MBBS||(65) 6772 4661||David_SP_Tan@nuhs.edu.sg|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Mei Yan Pang (65) 6772 3062 firstname.lastname@example.org|
|Contact: Christine Vergara (65) 6772 4619 email@example.com|
|Sub-Investigator: David SP Tan, MBBS|
|Principal Investigator:||Boon Cher Goh, MBBS||National University Hospital, Singapore|