CompletedPhase 1

Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer

United States286 participantsStarted 2012-07-23

Plain-language summary

The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Malignancies that are refractory to or intolerant of established therapy known to provide clinical benefit. Patients must not be candidates for anti-tumor regimes known to provide clinical benefit.

Exclusion criteria

✕. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.
✕. Patients with active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation except for patients with AML, where at least 2 months must have elapsed;
✕. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);
✕. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS symptom may be included.
✕. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
✕. Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
✕. Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.
✕. In the opinion of the investigator, patients who are significantly below their ideal body weight.

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug administration to end of treatment (up to 27 months)

Recommended Phase 2 Dose (RP2D) of Selinexor

Timeframe: From first dose of study drug administration to end of treatment (up to 27 months)

Trial details

NCT IDNCT01607892

SponsorKaryopharm Therapeutics Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-13

Results submitted2021-02-01

View on ClinicalTrials.gov More Hematological Malignancies trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Malignancies that are refractory to or intolerant of established therapy known to provide clinical benefit. Patients must not be candidates for anti-tumor regimes known to provide clinical benefit.

Exclusion criteria

✕. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1.
✕. Patients with active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation except for patients with AML, where at least 2 months must have elapsed;
✕. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);
✕. Patients with active CNS malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. Patient with malignant cells in their cerebrospinal fluid (CSF) without CNS symptom may be included.
✕. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
✕. Grade ≥2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
✕. Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.
✕. In the opinion of the investigator, patients who are significantly below their ideal body weight.

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug administration to end of treatment (up to 27 months)

Recommended Phase 2 Dose (RP2D) of Selinexor

Timeframe: From first dose of study drug administration to end of treatment (up to 27 months)