NCT02215161 is a Phase 2 clinical trial of Selinexor in Castration Levels of Testosterone, sponsored by University of California, San Francisco.

Who is sponsoring NCT02215161?

NCT02215161 is sponsored by University of California, San Francisco.

What drugs are being tested in NCT02215161?

Interventions in NCT02215161: Selinexor.

What condition does NCT02215161 study?

NCT02215161 studies Castration Levels of Testosterone, Hormone-Resistant Prostate Cancer, Metastatic Prostate Carcinoma in the Soft Tissue, Prostate Carcinoma Metastatic in the Bone, PSA Progression, Stage IV Prostate Adenocarcinoma AJCC v7.

Is NCT02215161 still recruiting?

NCT02215161 is currently terminated. Last updated 26 June 2018.

Are results published for NCT02215161?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-26 · How we verify

NCT02215161

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Selinexor in Treating Patients With Abiraterone Acetate and/or Enzalutamide Refractory Metastatic Castration-Resistant Prostate Cancer

Terminated Phase 2 Results posted Last updated 26 June 2018

What this trial tests

Phase 2 trial testing Selinexor in Castration Levels of Testosterone in 14 participants. Terminated before completion.

Timeline

2 September 2014

Primary endpoint
15 February 2017

2 April 2018

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	2 September 2014
Primary completion	15 February 2017
Estimated completion	2 April 2018
Sites	1 location across United States

Drugs / interventions tested

Selinexor — full drug profile →

Conditions studied

Castration Levels of Testosterone — all drugs for Castration Levels of Testosterone →
Hormone-Resistant Prostate Cancer — all drugs for Hormone-Resistant Prostate Cancer →
Metastatic Prostate Carcinoma in the Soft Tissue — all drugs for Metastatic Prostate Carcinoma in the Soft Tissue →
Prostate Carcinoma Metastatic in the Bone — all drugs for Prostate Carcinoma Metastatic in the Bone →

Sponsor

University of California, San Francisco

Who can join

18 and older, male only, with Castration Levels of Testosterone or Hormone-Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Radiographic Progression Free Survival (rPFS) Primary · From study start up to 3 years

Defined as the time from study start until one of the following events occurs: \>= 2 new bone lesions on technetium bone scan; Response Evaluation Criteria in Solid Tumors (RECIST)-defined tumor progression; clinical deterioration requiring a change in prostate cancer therapy, or at clinician discretion; surgery or radiation to treat a prostate cancer related indication; or death from any cause.

Group	Value	95% CI
Treatment (Selinexor)	31	7 – 47

Time to PSA Progression Secondary · Time between the first evaluation at which the response criteria are met and the first documentation of PSA progression or death or up to 3 years

Time between the first evaluation at which the response criteria are met and the first documentation of PSA (Prostate-Specific Antigen) progression or death. Progression is defined as a rise in PSA of 50% above nadir value or 25% above baseline if there is no decline.

Group	Value	95% CI
Treatment (Selinexor)	12	7 – 14

Incidence of Non-serious Adverse Events Secondary · Up to 3 years after treatment start

Incidence of non-serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Anorexia

Group	Value	95% CI
Treatment (Selinexor)	14

Hypophosphatemia

Group	Value	95% CI
Treatment (Selinexor)	3

Metabolism and nutrition disorders - Other

Group	Value	95% CI
Treatment (Selinexor)	2

Hypocalcemia

Group	Value	95% CI
Treatment (Selinexor)	1

Hyponatremia

Group	Value	95% CI
Treatment (Selinexor)	2

Weight loss

Group	Value	95% CI
Treatment (Selinexor)	7

Platelet count decreased

Group	Value	95% CI
Treatment (Selinexor)	6

INR increased

Group	Value	95% CI
Treatment (Selinexor)	3

PSA Decline of ≥50% at 12 Weeks Post Therapy Initiation Secondary · At 12 weeks post therapy initiation

The number of patients experiencing a PSA decline from baseline of at least 50% in PSA at 12 weeks following the initiation of study therapy.

Group	Value	95% CI
Treatment (Selinexor)	1

Reduction in Pain for Symptomatic Patients, Measured Using the Brief Pain Inventory (BPI), Short Form Secondary · At baseline and day 1 of every following cycle until end of treatment or 3 years after study start

The effect of selinexor on persistent pain associated with bone metastasis, measured using the Brief Pain Inventory (BPI), Short Form. 0 denotes ''no pain'' and 10, ''pain as bad as you can imagine".

Group	Value	95% CI
Pain at Baseline	1.34	1 – 4

Incidence of Serious Adverse Events Secondary · Up to 3 years after treatment start

Incidence of serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Anemia

Group	Value	95% CI
Treatment (Selinexor)	1

Eye disorders - Other

Group	Value	95% CI
Treatment (Selinexor)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years, 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Selinexor)

Serious: 4/14 (29%)

Deaths: 0/14

Serious adverse events (4 terms)

Reaction	System	Treatment (Selinexor)
Anemia	Blood and lymphatic system disorders	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—
Eye disorders - Other, specify	Eye disorders	—
Anorexia	Metabolism and nutrition disorders	—

Other adverse events (49 terms — click to expand)

Reaction	System	Treatment (Selinexor)
Anorexia	Metabolism and nutrition disorders	—
Nausea	Gastrointestinal disorders	—
Weight loss	Investigations	—
Fatigue	General disorders	—
Anemia	Blood and lymphatic system disorders	—
Hypotension	Vascular disorders	—
Platelet count decreased	Investigations	—
Vomiting	Gastrointestinal disorders	—
Hot flashes	Vascular disorders	—
Hypophosphatemia	Metabolism and nutrition disorders	—
Constipation	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—
Psychosis	Psychiatric disorders	—
Metabolism and nutrition disorders - Other, specify	Metabolism and nutrition disorders	—
Pain	General disorders	—
Bone pain	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—
Presyncope	Nervous system disorders	—
Eye pain	Eye disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—
Hypocalcemia	Metabolism and nutrition disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
INR increased	Investigations	—
Investigations - Other, specify	Investigations	—
Neutrophil count decreased	Investigations	—
Abdominal distension	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Flatulence	Gastrointestinal disorders	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—
Localized edema	General disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Musculoskeletal and connective tissue disorder - Other, specify	Musculoskeletal and connective tissue disorders	—
Headache	Nervous system disorders	—
Blurred vision	Eye disorders	—
Night blindness	Eye disorders	—
Watering eyes	Eye disorders	—
Lung infection	Infections and infestations	—

Most-reported serious reactions: Anemia, Blood and lymphatic system disorders - Other, specify, Eye disorders - Other, specify, Anorexia.

Data from ClinicalTrials.gov NCT02215161 adverse events section.

Sponsor's own description

This phase II trial studies selinexor in treating patients with prostate cancer that has spread to other parts of the body (metastatic), keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant), and did not respond to treatment (refractory) with abiraterone acetate and/or enzalutamide. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

XPO1-dependent nuclear export as a target for cancer therapy.
Azizian NG, Li Y. · · 2020 · cited 183× · PMID 32487143 · DOI 10.1186/s13045-020-00903-4
The past, present, and future of CRM1/XPO1 inhibitors.
Wang AY, Liu H. · · 2019 · cited 85× · PMID 30976603 · DOI 10.21037/sci.2019.02.03
Current concepts in bone metastasis, contemporary therapeutic strategies and ongoing clinical trials.
Gdowski AS, Ranjan A, Vishwanatha JK. · · 2017 · cited 83× · PMID 28800754 · DOI 10.1186/s13046-017-0578-1
Controlling the Gatekeeper: Therapeutic Targeting of Nuclear Transport.
Kosyna FK, Depping R. · · 2018 · cited 58× · PMID 30469340 · DOI 10.3390/cells7110221
A Phase II Trial of Selinexor, an Oral Selective Inhibitor of Nuclear Export Compound, in Abiraterone- and/or Enzalutamide-Refractory Metastatic Castration-Resistant Prostate Cancer.
Wei XX, Siegel AP, Aggarwal R, Lin AM, et al · · 2018 · cited 27× · PMID 29487219 · DOI 10.1634/theoncologist.2017-0624
New drugs in prostate cancer.
Yoo S, Choi SY, You D, Kim CS. · · 2016 · cited 21× · PMID 27358841 · DOI 10.1016/j.prnil.2016.05.001
The nuclear export protein exportin-1 in solid malignant tumours: From biology to clinical trials.
Lai C, Xu L, Dai S. · · 2024 · cited 16× · PMID 38783482 · DOI 10.1002/ctm2.1684
Down-regulation of AR splice variants through XPO1 suppression contributes to the inhibition of prostate cancer progression.
Aboukameel A, Muqbil I, Baloglu E, Senapedis W, et al · · 2018 · cited 13× · PMID 30450161 · DOI 10.18632/oncotarget.26239

Verify or expand the search:

Other trials of Selinexor

Trials testing the same drug.

NCT07447817 — Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias · Phase 2 · not yet recruiting
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07204041 — Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory · Phase 2 · active not recruiting
NCT06966154 — A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Se · Phase 1, PHASE2 · recruiting
NCT06900088 — Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients · Phase 2 · not yet recruiting

Other recruiting trials for Castration Levels of Testosterone

Currently open trials in the same condition.

NCT03678025 — Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer · Phase 3 · recruiting
NCT03419234 — Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metast · Phase 2 · active not recruiting
NCT02703623 — Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating P · Phase 2 · active not recruiting

Other University of California, San Francisco trials

Trials by the same sponsor.

NCT05284773 — Screening for Acute Malnutrition · NA · withdrawn
NCT04634851 — Video Home Visits for Dietary Counselling · NA · not yet recruiting
NCT06065670 — Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a M · Phase 1, PHASE2 · not yet recruiting
NCT07534098 — Intervention for Hearing Health Among Native Americans · NA · not yet recruiting
NCT06960421 — Exercise-based Frailty Intervention in Lung Transplantation (XFIT) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02215161 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 26 June 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02215161.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing