NCT04256707 - Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment | Biotech Hunter

Enrollment

126

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions

Non-Small Cell Lung Carcinoma (NSCLC)Colorectal Cancer (CRC)Other Solid Tumors

Interventions

DRUG

Selinexor 100 mg

"100-mg 2 formulations:~* 5 × 20-mg tablets (Tablet A)~* 1 × 100-mg tablet (Tablet B)"

DRUG

Docetaxel

75 mg/m\^2 IV

DRUG

Pembrolizumab

200 mg IV

DRUG

FOLFIRI

"FOLFIRI:~* Irinotecan 180 mg/m\^2~* Leucovorin 400 mg/m\^2~* 5-FU 400 mg/m\^2 bolus~* 5-FU 2400 mg/m\^2 IV"

DRUG

Selinexor 40 mg

\- 2 × 20-mg tablets (Tablet A)

DRUG

Selinexor 80 mg

\- 4 × 20-mg tablets (Tablet A)

DRUG

Selinexor 60 mg

\- 3× 20-mg tablets (Tablet A)

Trial Locations (11)

22100

Galilee Medical Center, Nahariya

38100

Oncology Department Hillel Yaffe Medical Center, Hadera

49100

Rabin Medical Center, Petah Tikva

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

84101

Soroka University Medical Center, Beersheba

91120

Hadassah Ein Karem University Hospital, Jerusalem

3109601

Rambam Health Care Campus, Haifa

4428164

Meir Medical Center, Kfar Saba

5265601

Sheba Medical Center, Tel Litwinsky

7747629

University Hospital Assuta Ashdod, Ashdod

9103102

Shaarei Zedek Medical Center, Jerusalem