Clinical trial NCT01149434 (phase 1/phase 2, status: terminated)
Conditions: cancer, neuroendocrine, ovarian cancer, colon cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3
Drugs: ji-101, everolimus
SMILES: COC1=CC=C(Br)C=C1NC(=O)NC1=C2C=CN(CC3=CC=NC(N)=C3)C2=CC=C1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    lack of drug efficacy
  
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, ≥18 years of age

          2. 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.

          3. At least one measurable tumor as defined by RECIST

          4. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of
             all prior systemic anticancer therapy

          5. Eastern Cooperative Oncology Group (ECOG) of 0 to 2

          6. Organ &marrow function as defined in the protocol.

          7. No evidence of preexisting uncontrolled hypertension as documented by two baseline
             blood pressure readings taken at least 1 hour apart

          8. Clinically euthyroid

          9. Normal range cardiac function

         10. For female patients of child-bearing potential, a negative serum pregnancy test at
             Screening.

         11. Current use of an acceptable form of double-barrier birth control

         12. Have provided written informed consent

        Exclusion Criteria:

          1. Known brain or other central nervous system metastases metastases that are not stable
             for 3 months or longer

          2. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other
             gastrointestinal conditions with increased risk of perforation.

          3. Major surgery, radiotherapy, chemotherapy, or cytokine therapy within 28 days of Study
             Day 0;

          4. History of intratumoral bleeding or evidence of bleeding diathesis or coagulopathy

          5. Female patients who are pregnant, planning a pregnancy, or who are breastfeeding

          6. Known allergy or hypersensitivity to JI-101 or everolimus or any component of the
             investigational products

          7. Use of an investigational drug/device/biologic within 28 days of Study Day 0

          8. Current drug or alcohol abuse or history of drug or alcohol abuse within the past two
             years

          9. 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)

         10. History of cardiac abnormalities

         11. Gastrointestinal (GI) abnormalities

         12. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior
             to Study Day 0

         13. History of cerebrovascular accident including transient ischemic attack within the
             past 6 months

         14. History of pulmonary embolism or deep vein thrombosis within the past 6 months

         15. 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

         16. Treatment with heparin or heparin analogs

         17. Inability or unwillingness to meet the requirements of the study

         18. 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.

         19. Any clinically significant abnormal finding at screening that the investigator judges
             would interfere with study participation