Status:
TERMINATED
Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Jubilant Innovation Ltd.
Conditions:
Cancer
Neuroendocrine
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The study consists of two parts: Drug Interaction (Pharmacokinetic) Phase and Pharmacodynamic Phase The primary study objective for the Drug Interaction Study is to determine the pharmacokinetic inte...
Detailed Description
This is a multi-center, non-randomized, open-label study to evaluate the safety and efficacy of RAD001 and JI-101 in patients with solid tumors. Patients will complete all Screening evaluations withi...
Eligibility Criteria
Inclusion
- Male or female, ≥18 years of age
- For the Pharmacokinetic Drug Interaction Study: Histologically or cytologically confirmed advanced solid tumors that are refractory to all standard of care therapy or for whom no standard therapy is available, or for whom other standard therapies the patient has denied. For the Pharmacodynamic Study: Histologically or cytologically confirmed metastatic/advanced ovarian carcinoma or metastatic/advanced KRAS mutant colorectal cancer or metastatic/advanced Head and neck squamous cell cancer (HNSCC) that are refractory to all standard therapies therapy or for whom no standard therapy is available, or for whom other standard therapies the patient has denied.
- At least one measurable tumor as defined by RECIST
- Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
- Eastern Cooperative Oncology Group (ECOG) of 0 to 2
- Organ \&marrow function as defined in the protocol.
- No evidence of preexisting uncontrolled hypertension as documented by two baseline blood pressure readings taken at least 1 hour apart
- Clinically euthyroid
- Normal range cardiac function
- For female patients of child-bearing potential, a negative serum pregnancy test at Screening.
- Current use of an acceptable form of double-barrier birth control
- Have provided written informed consent
Exclusion
- Known brain or other central nervous system metastases metastases that are not stable for 3 months or longer
- Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation.
- Major surgery, radiotherapy, chemotherapy, or cytokine therapy within 28 days of Study Day 0;
- History of intratumoral bleeding or evidence of bleeding diathesis or coagulopathy
- Female patients who are pregnant, planning a pregnancy, or who are breastfeeding
- Known allergy or hypersensitivity to JI-101 or everolimus or any component of the investigational products
- Use of an investigational drug/device/biologic within 28 days of Study Day 0
- Current drug or alcohol abuse or history of drug or alcohol abuse within the past two years
- Known history of or serologic positivity for the Hepatitis B Virus (HBV), or the Hepatitis C Virus (HCV), or for the human immunodeficiency virus (HIV)
- History of cardiac abnormalities
- Gastrointestinal (GI) abnormalities
- Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Study Day 0
- History of cerebrovascular accident including transient ischemic attack within the past 6 months
- History of pulmonary embolism or deep vein thrombosis within the past 6 months
- History of significant retinopathy or any progressive eye disease that could lead to severe loss of visual acuity or visual field loss during the study period
- Treatment with heparin or heparin analogs
- Inability or unwillingness to meet the requirements of the study
- Other current active malignancy or history of malignancy within the past five years, except for cervical carcinoma in situ, basal cell carcinoma that has been surgically removed, or prostate cancer that is being managed with watchful waiting.
- Any clinically significant abnormal finding at screening that the investigator judges would interfere with study participation
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01149434
Start Date
September 1 2010
End Date
August 1 2012
Last Update
October 6 2014
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112