A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Karyopharm Therapeutics, Inc
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01896505
First received: June 11, 2013
Last updated: July 23, 2015
Last verified: July 2015

June 11, 2013
July 23, 2015
July 2013
November 2015   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • Peak Plasma Concentration (Cmax) 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 ] [ Designated as safety issue: Yes ]
  • Comparison of AUC and Cmax of KPT-330 between: Treatment A vs B; Treatment C vs D; Treatment A vs C [ 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01896505 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: Yes ]
  • Change in laboratory parameters (serum chemistry, hematology and urinalysis) [ Time Frame: Baseline and Day 1 of weeks 1 -4 in Cycle 1 ] [ Designated as safety issue: Yes ]
  • Change in ECG parameters [ Time Frame: Baseline and Day 1 of each week (weeks 1-4) in Cycle 1 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number and percentages of patients involved per CTCAE Category and CTCAE Term [ Time Frame: After first dose of drug until final study visit ] [ Designated as safety issue: Yes ]
  • Highest relation of an AE to study drug [ Time Frame: After first dose until final visit ] [ Designated as safety issue: Yes ]
  • Maximum AE severity [ Time Frame: After first dose of study drug until the final study visit ] [ Designated as safety issue: Yes ]
Same as current
Biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo biopsy). [ Time Frame: Baseline and Week 3 or 4 of Cycle 1 ] [ Designated as safety issue: No ]
Same as current
 
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: KCP-330
Other Name: Selinexor
  • Experimental: Arm 1 - Treatment A, B, C, D

    There are 4 treatment formulations of KCP-330:

    A: fasted, tablet formulation B: high-fat meal, tablet formulation C: low-fat meal, tablet formulation D: low-fat meal, capsule formulation

    In Arm 1, the following order will be utilized:

    Week 1, day 1: Treatment A Week 2, day 1: Treatment B Week 3, day 1: Treatment C Week 4, day 1: Treatment D

    (Note that recruitment has been completed for this arm)

    Intervention: Drug: KCP-330
  • Experimental: Arm 2 - Treatment B, A, D, C

    There are 4 treatment formulations of KCP-330:

    A: fasted, tablet formulation B: high-fat meal, tablet formulation C: low-fat meal, tablet formulation D: low-fat meal, capsule formulation

    In Arm 2, the following order will be utilized:

    Week 1, day 1: Treatment B Week 2, day 1: Treatment A Week 3, day 1: Treatment D Week 4, day 1: Treatment C

    (Note that recruitment has been completed for this arm)

    Intervention: Drug: KCP-330
  • Experimental: Arm 3

    To evaluate tumor response in sarcoma patients (RECIST v1.1 criteria) on KCP-330.

    (Note that recruitment has been completed for this arm)

    Intervention: Drug: KCP-330
  • Experimental: Arm 4 - Treatment A, B, C

    There are 3 treatment formulations of KCP-330:

    A: Current (1st generation) tablets, 60 mg B: New (2nd generation) tablets, 60 mg C: Suspension dose of current (1st generation) tablets, 60 mg

    In Arm 4, the following order will be utilized:

    Week 1, day 1: Treatment A Week 2, day 1: Treatment B Week 3, day 1: Treatment C

    Intervention: Drug: KCP-330
  • Experimental: Arm 5 - Treatment C, A, B

    There are 3 treatment formulations of KCP-330:

    A: Current (1st generation) tablets, 60 mg B: New (2nd generation) tablets, 60 mg C: Suspension dose of current (1st generation) tablets, 60 mg

    In Arm 5, the following order will be utilized:

    Week 1, day 1: Treatment C Week 2, day 1: Treatment A Week 3, day 1: Treatment B

    Intervention: Drug: KCP-330
  • Experimental: Arm 6 - Treatment B, C, A

    There are 3 treatment formulations of KCP-330:

    A: Current (1st generation) tablets, 60 mg B: New (2nd generation) tablets, 60 mg C: Suspension dose of current (1st generation) tablets, 60 mg

    In Arm 6, the following order will be utilized:

    Week 1, day 1: Treatment B Week 2, day 1: Treatment C Week 3, day 1: Treatment A

    Intervention: Drug: KCP-330
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
53
December 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michael Kauffman, MD PhD +1 508-975-4822 mkauffman@karyopharm.com
United States,   Canada
 
NCT01896505
KCP-330-003
No
Karyopharm Therapeutics, Inc
Karyopharm Therapeutics, Inc
Not Provided
Not Provided
Karyopharm Therapeutics, Inc
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP