This trial is active, not recruiting.

Condition breast cancer
Treatment selinexor
Phase phase 2
Target XPO1
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator Karyopharm Therapeutics, Inc
Start date July 2015
End date March 2017
Trial size 10 participants
Trial identifier NCT02402764, MCC-18150


The main purpose of this study is to see whether the combination of selinexor (KPT-330) can help people with triple negative breast cancer (TNBC). Researchers also want to study the safety and tolerability of Selinexor in TNBC patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Screening period (which may last up to 28 days), followed by Selinexor treatment for qualified participants. During the treatment period, patients will undergo physical examination every 2 weeks until Cycle 6 Day 1 (C6D1), and then every 4 weeks and assessment of tumor response every 8 weeks. Participants will be treated until progression of disease or the development of unacceptable toxicities. All participants will then undergo a final visit (end of treatment visit).
selinexor KPT-330
Participants will receive selinexor twice weekly on Monday/Wednesday, Tuesday/Thursday or Wednesday/Friday of Weeks 1, 2 and 3 of each 4-week cycle. Selinexor will not be taken during Week 4. One cycle is defined as 28 days or 6 doses. The starting dose for this trial is 60 mg (flat dose as long as their dose-based body surface area (BSA) analysis does not exceed 70 mg/m^2).

Primary Outcomes

Clinical Benefit Rate
time frame: Up to 4 months

Secondary Outcomes

Best Overall Response (OR)
time frame: Up to 4 months
Duration of Overall Response
time frame: Up to 4 months
Progression-Free Survival (PFS)
time frame: Up to 4 months
Overall Survival (OS)
time frame: Up to 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed triple negative breast cancer (TNBC), defined as negative immunohistochemical staining for estrogen and progesterone receptors (≤5% of nuclei positive by IHC) and receptor tyrosine-protein kinase erbB-2 (HER2) negative (IHC 0-1+ or HER2-neu negative according to American Society of Clinical Oncology; College of American Pathologists (ASCO-CAP) HER2 Test Guideline Recommendations) - Written informed consent in accordance with federal, local, and institutional guidelines - Body surface area ≥1.4 m^2 - Age ≥18 years - Estimated life expectancy of >3 months at study entry - TNBC must be either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent. - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Documented disease progression at study entry - Must have received at least 1 chemotherapy regimens in the setting of metastatic disease - Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 - Adequate hematological function: Absolute neutrophil count (ANC) > 1500/mm^3, platelets count >100,000mm^3 - Adequate hepatic function within 14 days prior to Cycle 1 Day 1 (C1D1): total bilirubin <2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 times ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5 x ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, AST/ALT ≤5.0 times ULN is acceptable. - Amylase and lipase ≤ 1.5 x ULN - Adequate renal function within 14 days prior to C1D1: estimated creatinine clearance of ≥ 30 mL/min - Women of child-bearing potential (WOCBP) must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose. To be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or participants must be surgically sterile. - Must have received prior anthracycline and taxane therapy unless clinically contraindicated Exclusion Criteria: - Significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the participant's ability to tolerate this therapy - Women who are pregnant or lactating - Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy ≤2 weeks prior to cycle 1 day 1 - Major surgery within 4 weeks before Day 1 - Unstable cardiovascular function: Electrocardiogram (ECG) abnormalities requiring treatment, or congestive heart failure (CHF) of New York Hearth Association (NYHA) Class ≥3; myocardial infarction (MI) within 3 months - Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. Potential participants with controlled infection or on prophylactic antibiotics are permitted in the study. - Known history of HIV - Known active hepatitis A, B, or C infection that requires treatment - Any underlying condition that would significantly interfere with the absorption of an oral medication - Grade >2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1) - Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1 - Coagulation problems and active major bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding) - Active central nervous system (CNS) malignancy. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months. - Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy ≤ 4 weeks prior to Cycle 1 Day 1 - Have not recovered to Grade ≤ 1 or to their baseline from clinically significant adverse effects

Additional Information

Official title Investigator-Initiated Phase 2 Clinical Trial of Selinexor (KPT-330) for the Treatment of Metastatic Triple Negative Breast Cancer
Principal investigator Hyo S. Han, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.