Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer
NCT ID: NCT02178436
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2014-10-31
2023-04-05
Brief Summary
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Detailed Description
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1. Phase I: To determine the recommended phase 2 dose (RP2D) of gemcitabine, nabpaclitaxel and selinexor for untreated metastatic pancreatic cancer \[COMPLETED\]
2. Phase I: To determine the safety profile of gemcitabine, nab-paclitaxel and selinexor \[COMPLETED\]
3. Phase II: To test whether the combination of gemcitabine and selinexor improves the median overall survival of patients with metastatic pancreatic cancer who have failed frontline non-gemcitabine containing regimens beyond 5.6 months (median overall survival of patient receiving gemcitabine only based on historical data.
Secondary Objectives:
1. To determine objective response rate to the combination of gemcitabine and selinexor using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
2. To assess safety of selinexor in combination with gemcitabine in phase II portion of the study
3. To determine progression free survival (PFS) in patients treated with gemcitabine and selinexor
4. To determine the influence of selinexor and gemcitabine on the nuclear expression and localization of tumor suppressor gene proteins.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I: Phase Ib (gemcitabine, nab-paclitaxel, selinexor)
Patients receive gemcitabine hydrochloride IV, nab-paclitaxel IV, and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
gemcitabine hydrochloride
Given IV
Selinexor
Given IV
Pharmacological Study
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Nab paclitaxel
Given IV
Group II: Phase II Group I (gemcitabine, selinexor)
Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Patients also receive selinexor PO on days 3, 8, and 15 of cycle 1 and on days 1, 8, and 15 for the subsequent cycles. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
gemcitabine hydrochloride
Given IV
Selinexor
Given IV
Pharmacological Study
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
GroupIII: Phase II Group II (gemcitabine, selinexor)
Patients receive gemcitabine hydrochloride IV and selinexor PO on days 1, 8, and 15. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
gemcitabine hydrochloride
Given IV
Selinexor
Given IV
Pharmacological Study
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Interventions
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gemcitabine hydrochloride
Given IV
Selinexor
Given IV
Pharmacological Study
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Nab paclitaxel
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with metastatic pancreatic adenocarcinoma not treated with chemotherapy for metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 100,000/mm\^3
* 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)
* Alanine aminotransferase (ALT) \< 2.5 times ULN
* Serum creatinine =\< 1.5 mg/dL
* Serum albumin \>= 3.0 g/dL
* Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
* Patients with history of previously treated malignancies who have no evidence of disease for last five years are allowed to participate
Exclusion Criteria
* Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =\< 3 weeks prior to cycle 1 day 1; mitomycin C or radio-immunotherapy 6 weeks prior to cycle 1 day 1
* Major surgery within four weeks before cycle 1 day 1
* Unstable cardiovascular function:
* Symptomatic ischemia, or
* Uncontrolled clinically significant conduction abnormalities (e.g.: ventricular tachycardia on antiarrhythmics are excluded and 1st degree atrioventricular \[AV\] block or asymptomatic left anterior fascicular block \[LAFB\]/right bundle branch block \[RBBB\] will not be excluded), or
* Congestive heart failure (CHF) of New York Heart Association (NYHA) class \>= 3, or
* Myocardial infarction (MI) within 3 months of cycle 1 day 1 dose
* Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose
* Known to be HIV seropositive who are on anti-HIV drugs because of the unknown interactions between these drugs and the study agents
* Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus \[HBV\] surface antigen)
* Patients with 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
* Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea
* Grade \>= 2 peripheral neuropathy within 14 days prior to cycle 1 day 1
* History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
* Patients with muscular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity based on physician's assessment
* Serious psychiatric or medical conditions that could interfere with treatment
* Participation in an investigational anti-cancer study within 3 weeks prior to cycle 1 day 1
* Concurrent therapy with approved or investigational anticancer therapeutic
* Presence of clinically significant ascites
19 Years
ALL
No
Sponsors
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Mohammed Najeeb Al Hallak
OTHER
Responsible Party
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Mohammed Najeeb Al Hallak
Principal Investigator
Principal Investigators
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Mohammed N Al Hallak, M.D.
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Countries
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References
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Azmi AS, Khan HY, Muqbil I, Aboukameel A, Neggers JE, Daelemans D, Mahipal A, Dyson G, Kamgar M, Al-Hallak MN, Tesfaye A, Kim S, Shidham V, M Mohammad R, Philip PA. Preclinical Assessment with Clinical Validation of Selinexor with Gemcitabine and Nab-Paclitaxel for the Treatment of Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2020 Mar 15;26(6):1338-1348. doi: 10.1158/1078-0432.CCR-19-1728. Epub 2019 Dec 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2014-01249
Identifier Type: OTHER
Identifier Source: secondary_id
2013-133
Identifier Type: -
Identifier Source: org_study_id
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