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Safety Study of KPT-330 in Patients With Advanced or Metastatic Solid Tumor Cancer

This study has been completed.
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc Identifier:
First received: May 16, 2012
Last updated: March 31, 2017
Last verified: March 2017
Phase 1 study to evaluate the safety and tolerability of KPT-330 and determine the Recommended Phase 2 Dose (RP2D) of KPT- 330 for advanced or metastatic solid tumor malignancies.

Condition Intervention Phase
Solid Tumor
Drug: KPT-330
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Advanced or Metastatic Solid Tumor Malignancies

Resource links provided by NLM:

Further study details as provided by Karyopharm Therapeutics Inc:

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: 2 and 12 months ]
    Severity of Adverse Events

Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of KPT-330 [ Time Frame: 2 and 12 months ]
    Changes in AUC over time

Enrollment: 189
Study Start Date: June 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solid Tumors
Drug: KPT-330
Subjects in this study will receive KPT-330 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 3 mg/m2 twice a week and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
Other Name: Selinexor

Detailed Description:
This is a phase 1a and phase 1b, open-label, dose-escalation study to evaluate the safety and tolerability of KPT-330 and determine the RP2D in patients with solid tumor malignancies.

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

Inclusion Criteria:

  1. Dose Escalation Phase: Patients with advanced or metastatic solid tumors for which no standard therapy is available. For Schedule 6 only: patients with colorectal cancer with liver metastasis.

    Dose Expansion Phase: Previously treated, metastatic or advanced recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically:

    • Up to 12 patients with metastatic colorectal cancer with a history of progression or recurrence following prior fluoropyrimidine, irinotecan and platinum containing regimens as well as bevacizumab. In addition, patients with Kras wild type tumor must have received at least one EGFR blocker.
    • Up to 6 patients with histological or cytological documentation of advanced ovarian, fallopian tube, or primary peritoneal carcinoma with a history of progression or recurrence following at least one prior platinum and one taxane based chemotherapy
    • Up to 12 patients with incurable Squamous cell cancers as follows:

      1. A minimum of 4 Squamous Non-Small Cell Lung Cancer (Sq-NSCLC)
      2. A minimum of 4 Squamous Cell Carcinomas of the Head and Neck (Sq-HNC)
      3. Squamous Cell Carcinoma of the Cervix (SqCC) All patient with Squamous Cell Carcinomas should have a documented history of progression or recurrence following at least one prior platinum based chemotherapy or chemotherapy/radiation containing regimen
    • Up to 6 patients with castration-resistant prostate cancer (CRPC) that was pathologically confirmed as adenocarcinoma of the prostate and with evidence of metastatic disease on bone scan or other imaging. Patient must have progressive disease after at least one hormonal treatment and one cytotoxic therapy e.g. with docetaxel, mitoxantrone.
    • Up to 6 patients with recurrent/relapsed glioblastoma multiforme (GBM/AnaA) or with grade 3 anaplastic astrocytomas that with a history of progression or recurrence following radiotherapy and an alkylating agent (e.g. temozolomide) Patients with other disease types may be enrolled into the expansion phase upon approval of the Sponsor.
  2. Dose Escalation Phase: Patients have exhausted, or be deemed to not benefit from, further conventional therapy and have evidence of progressive disease on study entry.

Both Dose Escalation and Expansion Phases: There is no upper limit on the number of prior treatments provided that all inclusion criteria are met and exclusion criteria are not met. Hormone ablation therapy is considered an anticancer regimen. Radiation and surgery are not considered anticancer regimes.

Exclusion Criteria:

  1. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤3 weeks prior to cycle 1 day 1 and mitomycin C and radioimmunotherapy 6 weeks prior to cycle 1 day 1;
  2. Except for patients with GBM/ AnaA in the Expansion Phase, patients with active CNS malignancy are excluded. Asymptomatic small lesions are not considered active. Treated lesions may be considered inactive if they are stable for at least 3 months.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01607905

United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5T 2M9
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Study Director: Michael Kauffman, MD, Ph.D Karyopharm Therapeutics Inc
  More Information

Responsible Party: Karyopharm Therapeutics Inc Identifier: NCT01607905     History of Changes
Other Study ID Numbers: KCP-330-002
Study First Received: May 16, 2012
Last Updated: March 31, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Karyopharm Therapeutics Inc:
Squamous Cell Carcinoma
Glioblastoma multiforme
Melanoma processed this record on April 27, 2017