Selinexor Combination Ph 1 Study

Conditions

• Solid Tumor Malignancy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
• Irinotecan — DRUG

Study Details

The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of selinexor (KPT-330) in combination with Irinotecan in patients with solid tumors. A secondary purpose is to evaluate the pharmacokinetics (PK) of selinexor with irinotecan.

Key Dates

Start date

Sep 30, 2014

Status verified

Dec 2021

Primary completion

Sep 30, 2015

Completion

Sep 30, 2015

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Dose Level -1
  Selinexor 12mg po twice weekly (Monday \& Wednesday or Tuesday \& Thursday); Irinotecan 50mg/m2 IV once daily on days 1, 8 \& 15
• Experimental: Dose Level 1
  Selinexor 15mg po twice weekly (Monday \& Wednesday or Tuesday and Thursday); Irinotecan 75mg/m2 IV once daily on days 1, 8 \& 15.
• Experimental: Dose Level 2
  Selinexor 20mg po twice weekly (Monday \& Wednesday or Tuesday and Thursday); Irinotecan 100mg/m2 IV once daily on days 1, 8 \& 15.
• Experimental: Dose Level 3
  Selinexor 30mg po twice weekly (Monday \& Wednesday or Tuesday and Thursday); Irinotecan 75mg/m2 IV once daily on days 1, 8 \& 15.
• Experimental: Dose Level 4
  Selinexor 30mg po twice weekly (Monday \& Wednesday or Tuesday and Thursday); Irinotecan 125mg/m2 IV once daily on days 1, 8 \& 15.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: From date of first dose through study completion, an average of 1 year ]

Locations (1)

Find similar trials in Hackensack, NJ

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