Safety Study of KPT-330 in Patients With Advanced or Metastatic Solid Tumor Cancer
This trial is active, not recruiting.
|Sponsor||Karyopharm Therapeutics, Inc|
|Start date||June 2012|
|End date||March 2016|
|Trial size||188 participants|
|Trial identifier||NCT01607905, KCP-330-002|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Tampa, FL||Moffitt Cancer Center||no longer recruiting|
|Detroit, MI||Wayne State University / Karmanos Cancer Institute||no longer recruiting|
|New York, NY||Memorial Sloan-Kettering Cancer Center||no longer recruiting|
|Canton, OH||Gabrail Cancer Center||no longer recruiting|
|Houston, TX||M D Anderson Cancer Center||withdrawn|
|Toronto, Canada||Princess Margaret Hospital||no longer recruiting|
|Copenhagen, Denmark||Rigshospitalet||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of participants with Adverse Events
time frame: 2 and 12 months
Area under the plasma concentration versus time curve (AUC) of KPT-330
time frame: 2 and 12 months
Male or female participants at least 18 years old.
- 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:
- A minimum of 4 Squamous Non-Small Cell Lung Cancer (Sq-NSCLC)
- A minimum of 4 Squamous Cell Carcinomas of the Head and Neck (Sq-HNC)
- 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.
- 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 regimens.
- 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;
- 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.
|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|
|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.|
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