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Drug- Drug Interaction Study of JI-101 & Everolimus in Advanced Solid Tumors, Expansion Pharmacodynamic Study of JI-101 in Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer, Neuroendocrine, Ovarian Cancer, Colon Cancer

Thank you

Trial Information

Drug- Drug Interaction Study of JI-101 & Everolimus in Advanced Solid Tumors, Expansion Pharmacodynamic Study of JI-101 in Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers


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 within 21 days of Study Cycle 1Day 1. All
patients will provide written Informed consent and HIPAA authorization before any procedures
or assessments are initiated for the purposes of the protocol.

For the Drug Interaction Study, Everolimus will be administered to eligible patients at
Cycle 1 Day 1 and blood will be drawn for pharmacokinetic analyses prior to dosing and at
0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing. On Day 8, Everolimus and JI-101 will be
administered and blood will be drawn for pharmacokinetic analyses prior to dosing and at
0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing. On Day 15, JI-101 will be administered
and blood will be drawn for pharmacokinetic analyses prior to dosing and at 0.5, 1, 2, 4, 6,
8, 10, and 24 hours after dosing. Patients will continue to receive JI-101(200 mg BID) for
28 day treatment cycles. Patients in the Drug Interaction Study will also receive CT scans
prior to screening and every 2 treatment cycles.

For the Pharmacodynamic Study, JI-101 will be dispensed to eligible patients at Cycle 1 Day
1. JI-101 will be administered (200 mg BID) for 28 day treatment cycles. PET and CT scans
will be performed prior to commencing treatment if it is standard of care. A CT scan will be
performed otherwise. Patients will return to the study site every 2 cycles to complete
safety assessments with radiologic tumor assessments (CT and/or PET). Adverse events will
be monitored following the first administration of investigational product for the duration
of the patient's participation in this study. Archival tissue will be collected for
detection of mutations in relevant pathways and development of assays to study modulation of
pathways that are targeted by JI-101.


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 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. 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Outcome for Drug Interaction Study

Outcome Description:

The primary study objective for the Drug Interaction Study is to determine the pharmacokinetic interactions between RAD001 and JI-101

Outcome Time Frame:

August 2011

Safety Issue:

No

Principal Investigator

Sunil Sharma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

HCI43102

NCT ID:

NCT01149434

Start Date:

September 2010

Completion Date:

August 2012

Related Keywords:

  • Cancer
  • Neuroendocrine
  • Ovarian Cancer
  • Colon Cancer
  • Low grade endocrine tumors
  • ovarian cancers
  • K-RAS mutant colon cancers
  • Colonic Neoplasms
  • Endocrine Gland Neoplasms
  • Ovarian Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112