Arms
Experimental: Arm A (Colorectal Cancer)
Participants with colorectal cancer and liver metastasis received oral selinexor as
single agent in 8 schedules, Schedule1: ≤12milligrams per meter square(mg/m^2) 3 times
weekly(TIW) during Weeks 1 and 3, twice weekly(BIW) during Weeks 2 and 4 up to 10
doses/cycle(28 days/cycle); Schedule2: >12mg/m^2 TIW during Weeks 1 and 3, BIW in Weeks 2
and 4 up to 10 doses/cycle(28 days/cycle); Schedule3: ≥30mg/m^2 BIW(Days 1 and 3) up to 8
doses/cycle(28 days/cycle); Schedule4: ≥20mg/m^2 BIW(Days 1 and 2) up to 8 doses/cycle(28
days/cycle); Schedule5: ≥35mg/m^2 BIW(Days 1 and 4) up to 8 doses(28 days/cycle);
Schedule6: ≥20mg/m^2 BIW(Days 1 and 4) after 500 mg(Week 1) to 1000 mg(Week 2 onwards)
acetaminophen(given 1 hour prior to each selinexor dose) up to 8 doses/cycle (28
days/cycle); Schedule7: ≥50mg/m^2 once weekly(QW) up to 4 doses/cycle(28 days per cycle);
Schedule8: ≥45mg/m^2 BIW(Days 1 and 3) up to 4 doses/cycle(21 days/cycle), until disease
progression, death, or unacceptable toxicity.
Experimental: Arm B (Gynecological Cancer)
Participants with gynecological cancer received oral selinexor as a single agent in eight
schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up
to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW
in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1
and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up
to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses
(28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle);
Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until
disease progression, death, or unacceptable toxicity.
Experimental: Arm C (Squamous Cell Cancer)
Participants with squamous cell cancer received oral selinexor as a single agent in eight
schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up
to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW
in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1
and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up
to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses
(28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle);
Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until
disease progression, death, or unacceptable toxicity.
Experimental: Arm D (Castrate-resistant Prostate Cancer)
Participants with castrate-resistant prostate cancer (CRPC) received oral selinexor as a
single agent in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW
during Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW
during Weeks 1 and 3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule
3: ≥30 mg/m^2 BIW (Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20
mg/m^2 BIW (Days 1 and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW
(Days 1 and 4) up to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4
doses/cycle (28 days per cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4
doses/cycle (21 days/cycle), until disease progression, death, or unacceptable toxicity.
Experimental: Arm E (Glioblastoma Multiforme)
Participants with glioblastoma multiforme (GBM) received oral selinexor as a single agent
in eight schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2
and 4 up to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and
3, BIW in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW
(Days 1 and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1
and 2) up to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up
to 8 doses (28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per
cycle); Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle),
until disease progression, death, or unacceptable toxicity.
Experimental: Arm F (Melanoma)
Participants with Melanoma received oral selinexor as a single agent in eight schedules,
Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up to 10
doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW in
Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1
and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up
to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses
(28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle);
Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until
disease progression, death, or unacceptable toxicity.
Experimental: Arm G (Other Solid Tumors)
Participants with other solid tumors received oral selinexor as a single agent in eight
schedules, Schedule 1: ≤12 mg/m^2 TIW during Weeks 1 and 3, BIW during Weeks 2 and 4 up
to 10 doses/cycle (28 days/cycle); Schedule 2: >12 mg/m^2 TIW during Weeks 1 and 3, BIW
in Weeks 2 and 4 up to 10 doses/cycle (28 days/cycle); Schedule 3: ≥30 mg/m^2 BIW (Days 1
and 3) up to 8 doses/cycle (28 days/cycle); Schedule 4: ≥20 mg/m^2 BIW (Days 1 and 2) up
to 8 doses/cycle (28 days/cycle); Schedule 5: ≥35 mg/m^2 BIW (Days 1 and 4) up to 8 doses
(28 days/cycle); Schedule 7: ≥50 mg/m^2 QW up to 4 doses/cycle (28 days per cycle);
Schedule 8: ≥45 mg/m^2 BIW (Days 1 and 3) up to 4 doses/cycle (21 days/cycle), until
disease progression, death, or unacceptable toxicity.
Interventions
Drug: - Selinexor
Participants in this study will receive selinexor orally at dose levels specified for
their respective dose cohorts. Dosing will begin at 3 mg/m^2 twice a week and will
escalate until the MTD or RP2D is determined. Cycles will be repeated in 4-week (28 days
for schedule 1 to 7) and 3-week (21 days for schedule 8) intervals until progression of
disease, unacceptable toxicity, or another discontinuation criterion is met. In the case
of toxicity, dose adjustment will be permitted.
Drug: - Acetaminophen
Oral 500 mg (in Cycle 1, Week 1) to 1000 mg (in Cycle 1, Week 2 and onwards) of
acetaminophen will be administered 1 hour prior to each selinexor dose up to 8 doses per
cycle (28 days per cycle)
