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|NCT01607905 : Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced or Metastatic Solid Tumor Cancer|
|Ages||Min: 18 Years Max: N/A|
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
- 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
- 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 Doses Escalation and Expansion Phases: There is no upper limit on the number of prior
treatments provided all inclusion/exclusion criteria are met. Hormone ablation therapy is
considered an anticancer regimen. Radiation and surgery are not considered anticancer
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.
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