A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
This trial is active, not recruiting.
|Sponsor||Karyopharm Therapeutics, Inc|
|Start date||July 2013|
|End date||September 2016|
|Trial size||53 participants|
|Trial identifier||NCT01896505, KCP-330-003|
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets, to compare PK of capsules and tablets, to assess the effects of KPT-330 on cellular morphology and biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo biopsy).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||pharmacokinetics study|
|Intervention model||parallel assignment|
Area under the plasma concentration versus time curve (AUC) of KPT-330
time frame: At baseline (time 0) and on Day 1 of weeks 1 - 4 in Cycle 1 at the following timepoints:15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18 and 24 hours post dose
Tumor response in sarcoma patients (RECISTv1.1 criteria)
time frame: CT scans will be done at 8 weeks post dose and every 2 months while on study drug; and 30 days after the last dose in the study.
Change in laboratory parameters (serum chemistry, hematology and urinalysis)
time frame: Baseline and Day 1 of weeks 1 -4 in Cycle 1
Change in ECG parameters
time frame: Baseline and Day 1 of each week (weeks 1-4) in Cycle 1
Change in Vital sign parameters (Systolic pressure, diastolic pressure and heart rate)
time frame: Baseline and on Day 1 of each week (weeks 1 - 4) of Cycle 1
Number and percentages of patients involved per CTCAE Category and CTCAE Term
time frame: After first dose of drug until final study visit
Highest relation of an AE to study drug
time frame: After first dose until final visit
Maximum AE severity
time frame: After first dose of study drug until the final study visit
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded. 2. Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months Exclusion Criteria: 1. Patients with known liver metastases 2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy 3. Patients with known brain metastasis 4. Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data 5. Patients with known intolerance to low or high fat meals 6. In the opinion of the investigator, patients who are significantly below their ideal body weight
|Official title||An Open-Label Phase IB Trial To Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients Witn Soft-Tissue or Bone Sarcoma|
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