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Trial record 2 of 2 for:    selinexor | Colo-rectal Cancer

Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment (SPRINT)

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ClinicalTrials.gov Identifier: NCT04256707
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief Summary:

This is a Phase 1/2, two-part, multi-arm, open-label study in patients with normal Hepatic Function (HF), with either Non-small cell lung cancer (NSCLC), who have had 1-2 prior lines of treatment, with 1 line containing a checkpoint Inhibitor (CPI); or patients with normal HF, with colorectal cancer (CRC) who have had 1-3 prior lines (KRAS wild-type [WT]) or 1-2 prior lines (mutant KRAS) of treatment with no CPI; or patients with impaired HF, with any solid tumor, who have had at least 1 prior line of treatment.

The study will comprise 2 treatment periods (monotherapy and combination therapy).

The purposes of this study, during Monotherapy period, are: (1) to determine the relative bioavailability of the 100 milligrams (mg) (Tablet B) and 20 mg (Tablet A) tablets of selinexor at 100 mg once weekly (QW) dose in patients with normal hepatic function; and (2) to assess the PK of selinexor after a single dose of 40 mg (2 × 20 mg), among patients with moderate and severe hepatic impairment, relative to 100 mg (5 × 20 mg), among patients with normal hepatic function; and, during the Combination therapy period, to assess the preliminary anti-tumor activity of selinexor in combination with docetaxel in patients with NSCLC and with pembrolizumab or folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI) in patients with CRC.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Carcinoma (NSCLC) Colorectal Cancer (CRC) Other Solid Tumors Drug: Selinexor 100 mg Drug: Docetaxel Drug: Pembrolizumab Drug: FOLFIRI Drug: Selinexor 40 mg Drug: Selinexor 80 mg Drug: Selinexor 60 mg Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Two part study (monotherapy period and combination therapy period).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Phase 1/2 Study Evaluating the Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, and the Tolerability and Antitumor Activity of Selinexor Combination Treatment (SPRINT)
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Selinexor

Arm Intervention/treatment
Experimental: Monotherapy: Normal Hepatic Function (Selinexor)

Cohort 1:

  • Week 1: selinexor 5 x 20-mg tablet daily;
  • Week 2: selinexor 1 x 100-mg tablet daily

Cohort 2:

  • Week 1: selinexor 1 x 100-mg tablet daily;
  • Week 2: selinexor 5 x 20-mg tablet daily.
Drug: Selinexor 100 mg

100-mg 2 formulations:

  • 5 × 20-mg tablets (Tablet A)
  • 1 × 100-mg tablet (Tablet B)
Other Name: Xpovio®

Experimental: Monotherapy: Impaired Hepatic Function (Selinexor)

Cohort 3:

Patients with Moderate Hepatic Impairment with any Solid Tumors; - Selinexor 2 x 20-mg tablet once weekly (QW);

Cohort 4:

Patients with Severe Hepatic Impairment with any Solid Tumors;

- Selinexor 2 x 20-mg tablet QW.

Drug: Selinexor 40 mg
- 2 × 20-mg tablets (Tablet A)
Other Name: Xpovio®

Experimental: Combination Therapy: NSCLC Arm A: (Selinexor + Docetaxel)
Selinexor 60 mg oral dose QW and docetaxel 75 mg/m^2 intravenously (IV) once every 3 weeks (Non-small cell lung cancer [NSCLC] patients).
Drug: Docetaxel
75 mg/m^2 IV
Other Name: Taxotere®

Drug: Selinexor 60 mg
- 3× 20-mg tablets (Tablet A)
Other Name: Xpovio®

Experimental: Combination Therapy: CRC Arm B: (Selinexor + Pembrolizumab)
Selinexor 80 mg oral does QW and pembrolizumab 200 mg IV every 3 weeks (Colorectal cancer [CRC] Patients).
Drug: Pembrolizumab
200 mg IV
Other Name: Keytruda®

Drug: Selinexor 80 mg
- 4 × 20-mg tablets (Tablet A)
Other Name: Xpovio®

Experimental: Combination Therapy: CRC Arm C: (Selinexor + FOLFIRI)

Cohort 1:

Selinexor 40 mg oral dose Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m^2; leucovorin 400 mg/m^2; 5- fluorouracil (5-FU) 400 mg/m^2 bolus then 5-FU 2400 mg/m^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) (CRC Patients).

Cohort 2:

Selinexor 80 mg oral dose Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m^2; leucovorin 400 mg/m^2; 5-FU 400 mg/m^2 bolus then 5-FU 2400 mg/m^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) (CRC Patients).

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)
Other Name: Xpovio®

Drug: Selinexor 80 mg
- 4 × 20-mg tablets (Tablet A)
Other Name: Xpovio®




Primary Outcome Measures :
  1. Monotherapy Period: Area Under the Concentration-Time Curve from Time Zero to Time of Last Concentration (AUC 0-t) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Function [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  2. Monotherapy Period: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC 0-inf) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Function [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  3. Monotherapy Period: Maximum Plasma Concentration (Cmax) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Function [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  4. Combination Therapy Period: Arm A and B: Overall Response Rate (ORR) as Assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to 36 months ]
  5. Combination Therapy Period: Arm C: Number of Patients With Adverse Events (AEs) [ Time Frame: From start of study drug administration up to survival follow-up (Up to 36 months) ]

Secondary Outcome Measures :
  1. Monotherapy Period: Time to Maximum Observed Concentration (Tmax) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Impairment [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  2. Monotherapy Period: Terminal Elimination Rate Constant (Lambda z) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Impairment [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  3. Monotherapy Period: Terminal Half-Life (t1/2) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Impairment [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  4. Monotherapy Period: Apparent Clearance (CL/F) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Impairment [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  5. Monotherapy Period: Apparent Volume of Distribution (Vd/F) of Selinexor in Patients with Normal, Moderate and Severe Hepatic Impairment [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  6. Monotherapy Period: Fraction Unbound (fu) of Selinexor (Tablet A) in Plasma [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  7. Monotherapy Period: Maximum Free-Drug Concentration (Cmaxu) of Selinexor (Tablet A) in Plasma [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  8. Monotherapy Period: Area Under the Free-Drug Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCu) of Selinexor (Tablet A) in Plasma [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  9. Monotherapy Period: Apparent Free-drug Clearance (CLu/F) of Selinexor (Tablet A) in Plasma [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  10. Monotherapy Period: Apparent Free-drug Volume of Distribution (Vu/F) of Selinexor (Tablet A) in Plasma [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8 ]
  11. Combination Therapy Period: Arm A, B and C: Progression-free Survival (PFS) as Assessed by RECIST 1.1 [ Time Frame: Up to 36 months ]
  12. Combination Therapy Period: Arm A, B and C: Duration of Response (DOR) as Assessed by RECIST 1.1 [ Time Frame: Up to 36 months ]
  13. Combination Therapy Period: Arm A, B and C: Disease Control Rate (DCR) as Assessed by RECIST 1.1 [ Time Frame: Up to 36 months ]
  14. Combination Therapy Period: Arm A, B and C: Overall Survival (OS) as Assessed by RECIST 1.1 [ Time Frame: Up to 36 months ]
  15. Monotherapy Period: Number of Patients With Adverse Events (AEs) [ Time Frame: From start of study drug administration up to survival follow-up (up to 36 months) ]
  16. Combination Therapy Period: Arm A and B: Number of Patients With Adverse Events (AEs) [ Time Frame: From start of study drug administration up to survival follow-up (up to 36 months) ]
  17. Combination Therapy Period: Arm C: Overall Response Rate (ORR) as Assessed by RECIST 1.1 [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Common inclusion criteria for all patients:

  1. Are greater than or equal to [≥] 18 years of age.
  2. Have histologically confirmed solid tumor (any type of advanced or metastatic solid tumor for the Hepatic Impairment Arm of the Monotherapy Part), advanced or metastatic NSCLC or CRC and evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  3. Willing to provide signed written informed consent in accordance with federal, local, and institutional guidelines and comply with all requirements of the study.
  4. Female patient of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective (dual methods of) contraception throughout the study and for 4 months following the last dose of study drug; and male patients must use an effective barrier method of contraception throughout the study and for 4 months following the last dose of study drug if sexually active.

    For the Monotherapy Part only (bioavailability/bioequivalence [BA/BE] and hepatic impairment [HI] arms):

  5. Have received at least 1 line of systemic anticancer treatment unless there is no first-line standard of care therapy or standard of care therapy is contraindicated adjuvant or neoadjuvant therapy is not counted as one line of systemic therapy). Patients must have failed prior standard curative therapy for their disease, must be intolerant to or be ineligible for any potentially curative approved treatment, irrespective of line of therapy.
  6. Must have either normal hepatic function, or moderate or severe hepatic impairment (as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria:

    1. S20-100 and S100-20 arms: normal hepatic function (total bilirubin and aspartate aminotransferase [AST] less than or equal to [≤] upper limit of normal [ULN]).

      Note: Patients with mild hepatic dysfunction (total bilirubin greater than [>] 1 to 1.5 × ULN or AST > ULN) may be included if liver function tests are stable for the past 3 months and enrollment is approved in writing by the Sponsor's Medical Monitor.

    2. MHI arm: ≥1 week of documented moderate hepatic impairment (total bilirubin >1.5-3 × ULN, any level of AST).
    3. SHI arm: ≥1 week of documented severe hepatic impairment (total bilirubin >3-10 × ULN, any level of AST).

    For Combination Therapy Part only:

  7. Previous treatment lines (adjuvant or neoadjuvant therapy is not counted as one line of systemic therapy):

    1. Arm A: For patients with NSCLC, have received 1-2 prior lines of systemic anti-cancer treatment with 1 regimen including an anti-PD-1/L1 monoclonal antibody (mAb)
    2. Arm B: For patients with CRC, no prior anti- programmed cell death protein 1/L1 monoclonal antibody (anti-PD-1/L1 mAb).

      • KRAS WT: have 1-3 prior lines of systemic treatments.
      • KRAS mutant (at least 50 percent [%] of patients): 1-2 prior lines of systemic treatments.
    3. Arm C: For patients with CRC participating in the combination arm with FOLFIRI, 1-2 prior lines of systemic therapy are allowed.
    4. Arm B and C in CRC: patient with CRC is not a candidate for curative resection of metastatic lesions.
  8. Must have hepatic function as follows:

    1. Arm A (combination with docetaxel): patients with NSCLC who are to receive docetaxel and have bilirubin ≤ ULN, and AST and/or alanine transaminase (ALT) ≤ 1.5 x ULN.
    2. Arm B and C: total bilirubin ≤ 1.5 × ULN and AST ≤ 2.5 x ULN, AST ≤ 2.5 x ULN; for Arm B, unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin must be ≤ 4 x ULN.

Key Exclusion Criteria:

Common exclusion criteria for all patients:

  1. Have inadequate hematopoietic function defined as (without transfusion or growth factor support within 7 days prior to first dose):

    a. absolute neutrophil count (ANC) <1.5 × 109/liter (L); platelet count (PLT) <100 × 109/L; or hemoglobin (Hb) <9 gram per deciliter (g/dL).

  2. Have inadequate renal function defined as a calculated creatinine clearance (CrCl) of <20 mL/min using the formula of Cockcroft and Gault.
  3. Have any other medical condition especially any gastrointestinal (GI) dysfunctions or GI disease that could interfere with the absorption of selinexor (e.g., inability to swallow or retain oral medications, malabsorption syndrome, a history of GI surgery which may result in intestinal blind loop, significant gastroparesis, unresolved nausea, vomiting, or diarrhea [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade >1]).
  4. Ongoing infection requiring parenteral antibiotics, antivirals, or antifungals on Day 1 dosing.
  5. Prior exposure to a SINE compound or selinexor.
  6. Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:

    1. Not recovered from major surgery ≤21 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted.
    2. Have ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade >1. Patients with any of the following will not be excluded: immune checkpoint-related endocrinopathies that are well controlled with hormonal supplements, patients with electrolyte abnormalities that are well-managed with supplementation, patients with Grade 2 lymphopenia, or patients with alopecia of any grade. In specific cases, patients whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor.
    3. Had last dose of previous anti-cancer therapy ≤14 days prior to Day 1 dosing.
    4. Radiotherapy within 4 weeks before the study. Palliative radiotherapy >14 days prior to the study is allowed.
    5. Received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug (whichever is shorter), prior to Cycle 1 Day 1 (C1D1).
  7. Serious active psychiatric or active medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
  8. In the opinion of the Investigator, patients who are below their ideal body weight and would be unduly impacted by changes in their weight.
  9. Known allergy to selinexor (all patients), docetaxel (NSCLC Arm A only), pembrolizumab (CRC arm B only), OR 5-FU, leucovorin, or irinotecan (CRC Arm C only).
  10. Female patients who are pregnant or breastfeeding. For Monotherapy Part only (BA/BE and HI arms):
  11. Have an Eastern Cooperative Oncology Group (ECOG) performance status of:

    1. ≥3 for patients to be enrolled into the S20-100 or S100-20 arms of the study.
    2. ≥4 for patients to be enrolled into the MHI and SHI arms of the study.
  12. For MHI and SHI arms: ANC <1 × 109/L; PLT <75 × 109/L; or Hb <8 g/dL.
  13. Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing OR strong CYP3A inducers ≤14 days prior to Day 1 dosing.
  14. Inability or unwillingness to undergo a series of PK sampling.

    For Combination Therapy Part only:

  15. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≥3 for Arms A and B and ECOG PS ≥2 for Arm C.
  16. Arm B patients with CRC who are to receive pembrolizumab:

    1. Had a diagnosis of immunodeficiency or are receiving systemic steroid therapy (>10 milligram per day [mg/day] of prednisone or equivalent) or any other form of immunosuppressive therapy.
    2. Patients with controlled diabetes mellitus and patients with endocrinopathies on stable hormone replacement therapy, are eligible for the trial.
    3. Have active autoimmune disease requiring systemic treatment during the past 2 years. Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted.

      Note: The Investigator needs to evaluate the patient's medical history to confirm that they are eligible to receive the combination with pembrolizumab per these criteria.

    4. For patients with CRC who have received live-attenuated vaccine against an infectious disease (e.g., nasal spray influenza vaccine) ≤14 days prior to the intended C1D1 of the Combination Therapy.
  17. Arm C: Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Note: for patients who are initially enrolled onto the BA/BE arm in the monotherapy part and plan to switch to combination therapy after completing the planned dosing and PK sample collection, dose interruption between the Monotherapy Part and the Combination Therapy Part is allowed for recovery from AEs. Patients requiring >21 days to recover from toxicities related to selinexor should be discussed with the Sponsor's Medical Monitor for documented approval to continue to the Combination Therapy Part if inclusion/exclusion criteria are met. Experiencing PD during the Monotherapy Part does not constitute exclusion from the Combination Therapy Part.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256707


Contacts
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Contact: Michael Kauffman, MD, PhD (617) 658-0600 mkauffman@karyopharm.com
Contact: Sharon Shacham, PhD, MBA (617) 658-0600 sshacham@karyopharm.com

Locations
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Israel
University Hospital Assuta Ashdod Not yet recruiting
Ashdod, Israel, 7747629
Contact: Larissa Ryvo, MD    972 72 3398126    larisar@assuta.co.il   
Principal Investigator: Larissa Ryvo, MD         
Soroka University Medical Center Recruiting
Beer-Sheva, Israel, 84101
Contact: Julia Dudnik, MD    +97286400537    juliad@clalit.org.il   
Principal Investigator: Julia Dudnik, MD         
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Talia Shentzer Kutiel, MD    972 4 7776473    t_shentzer@rambam.health.gov.il   
Principal Investigator: Talia Shentzer Kutiel, MD         
Shaarei Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 9103102
Contact: Nir Peled, MD    972 2 5645201    nirp@szmc.org.il   
Principal Investigator: Nir Peled, MD         
Hadassah Ein Karem University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Aviad Zick, MD    972 2 6776725    aviadz@hadassah.org.il   
Principal Investigator: Aviad Zick, MD         
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Contact: Maya Gottfried, MD    972 9 7472414    Maya.Gottfried@clalit.org.il   
Principal Investigator: Maya Gottfried, MD         
Galilee Medical Center Not yet recruiting
Nahariya, Israel, 22100
Contact: Ayelet Shai, MD    972 4 9107149    AyeletS@gmc.gov.il   
Principal Investigator: Ayelet Shai, MD         
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Alona Zer, MD    972 3 9378146    alonaz@clalit.org.il   
Principal Investigator: Alona Zer, MD         
Tel-Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Ravit Geva, MD    972 3 6972966    ravitg@tlvmc.gov.il   
Principal Investigator: Ravit Geva, MD         
Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 5265601
Contact: Talia Golan, MD    972 3 5305338    Talia.Golan@sheba.health.gov.il   
Principal Investigator: Talia Golan, MD         
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Study Director: Michael Kauffman, MD, PhD Karyopharm Therapeutics Inc
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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04256707    
Other Study ID Numbers: KCP-330-027
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karyopharm Therapeutics Inc:
Non-small cell lung carcinoma
Selinexor
Docetaxel
Colorectal cancer
KPT-330
Bioequivalence
Relative bioavailability
Pharmacokinetics
Other Solid Tumors
Additional relevant MeSH terms:
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Colorectal Neoplasms
Lung Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Docetaxel
Pembrolizumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological