7/25/2017
`
`NCT00093782 on 2005_06_23: ClinicalTrials.gov Archive
`
`Clmrca!Trials.gov archive
`
`A sen-ice oi Ihe U.S. Nalional Inslilules of Health
`
`<— History of this study
`
`T Current version of this study
`
`View of NCT00093782 on 2005_06_23
`
`ClinicalTrials Identifier: NCT00093782
`
`Updated:
`
`2005_06_23
`
`Drawing I3: lhe National Library of Medicine
`
`Descriptive Information
`
`Brief title
`
`Official title
`
`Brief summary
`
`CCl-779 in Treating Patients With Progressive Metastatic
`Neuroendocrine Tumors
`
`Phase II Study of CCl-779 in Patients With Progressive Metastatic
`Neuroendocrine Tumors
`
`RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to
`stop tumor cells from dividing so they stop growing or die.
`
`PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients
`with progressive metastatic neuroendocrine tumors.
`
`Detailed description
`OBJECTIVES:
`
`- Determine the objective tumor response rate (i.e., partial or complete response) in
`patients with progressive metastatic neuroendocrine tumors treated with CCI-779.
`- Determine the stable disease rate and duration, time to disease progression, median
`survival time, and 1-year survival rate in patients treated with this drug.
`- Determine the toxicity of this drug in these patients.
`
`OUTLINE: This is an open-label, multicenter study.
`
`Patients receive CCl-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment
`repeats every 28 days for up to 6 courses in the absence of disease progression or
`unacceptable toxicity. Patients who achieve a complete response (CR) or partial
`response (PR) receive 2 additional courses beyond CR or PR.
`
`Patients are followed for survival.
`
`PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study within
`5-15 months.
`
`Phase
`
`Phase 2
`
`Study type
`
`lnterventional
`
`Study design
`
`Treatment
`
`Condition
`Condition
`
`Condition
`_
`Intervention
`
`gastrointestinal carcinoid tumor
`Islet Cell Carcinoma
`
`pulmonary carcinoid tumor
`,
`.
`Drug: temSIrollmus
`
`Procedure: chemotherapy
`Intervention
`httpszllclinicaltrialsgov/archive/N CT000937822005_06_23
`
`Par Pharm., Inc.
`Exhibit 1104
`
`1/4
`
`Par Pharm., Inc. v. Novartis AG
`Case |PR2016-01479
`
`Ex. 1 104-0001
`
`Ex. 1104-0001
`
`

`

`7/25/2017
`
`NCT00093782 on 2005_06_23: ClinicalTrials.gov Archive
`
`URL
`
`See also
`
`http://cancer.gov/clinicaltriaIs/PMH-PHL-021
`
`Clinical trial summary from the National Cancer Institute's PDQ®
`database
`
`Recruitment Information
`
`Status
`Criteria
`
`Recruiting
`
`DISEASE CHARACTERISTICS:
`
`- Histologically or cytologically confirmed neuroendocrine tumor
`
`- Carcinoid histology OR carcinoma of pancreatic islet cell origin
`
`- No small cell variant, endocrine organ carcinomas, or adrenal gland
`malignancies (including paragangliomas)
`- Metastatic disease
`- Measurable disease
`
`- At least 1 unidimensionally measurable lesion 2 20 mm by conventional techniques
`OR 2 10 mm by spiral CT scan
`- Not amenable to surgery
`- Documented progressive disease within the past 6 months, as defined by 1 of the
`following criteria:
`
`- At least 25% increase in radiologically or clinically measurable disease
`- Appearance of new lesions
`- Deterioration in clinical status
`
`- Must have tumor lesions accessible for biopsy
`- No known brain metastases
`
`PATIENT CHARACTERISTICS:
`
`Age
`- 18 and over
`
`Performance status
`- ECOG 0-2
`OR
`
`- Karnofsky 60-100%
`
`Life expectancy
`- More than 3 months
`
`Hematopoietic
`- WBC 2 3,000/mm"3
`- Absolute neutrophil count 2 1,500/mm"3
`- Platelet count 2 100,000/mm"3
`
`Hepatic
`- Bilirubin s 1.25 times upper limit of normal (ULN)
`- AST and ALT s 3 times ULN (< 5 times ULN if liver metastases are present)
`
`Renal
`
`https://clinicaltrials.gov/archive/N CT00093782/2005_06_23
`
`2/4
`
`Ex. 1 104-0002
`
`Ex. 1104-0002
`
`

`

`7/25/2017
`
`NCT00093782 on 2005_06_23: ClinicalTrials.gov Archive
`
`- Creatinine s 1.5 times ULN
`OR
`
`- Creatinine clearance 2 60 mL/min
`
`Cardiovascular
`
`- No symptomatic congestive heart failure
`- No unstable angina pectoris
`- No cardiac arrhythmia
`
`Other
`
`- Not pregnant or nursing
`- Negative pregnancy test
`- Fertile patients must use effective contraception
`- No active or ongoing infection
`- No history of allergic reaction attributed to compounds of similar chemical or
`biological composition to CCl-779
`- No psychiatric illness or social situation that would preclude study compliance
`- No other uncontrolled illness
`
`- No other malignancy within the past 3 years except curativer treated nonmelanoma
`skin cancer or carcinoma in situ of the cervix
`
`PRIOR CONCURRENT THERAPY:
`
`Biologic therapy
`- No concurrent prophylactic hematopoietic colony-stimulating factors
`
`Chemotherapy
`- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
`and recovered
`
`Endocrine therapy
`- Concurrent chronic somatostatin analogues for symptom control allowed provided
`treatment was initiated > 3 months before study entry
`
`Radiotherapy
`- More than 4 weeks since prior radiotherapy, including radioactive octreotide, and
`recovered
`
`Surgery
`- More than 6 weeks since prior surgery
`
`Other
`
`- More than 6 weeks since prior local therapy (e.g., chemoembolization or bland
`embolization)
`- More than 4 weeks since prior investigational agents
`- No concurrent combination antiretroviral therapy for HIV-positive patients
`- No other concurrent anticancer therapy
`- No other concurrent investigational agents
`Gender
`Both
`
`Minimum age
`
`Maximum age
`
`Healthy volunteers
`
`18 Years
`
`N/A
`
`No
`
`https://clinicaltrials.gov/archive/NCT00093782/2005_06_23
`
`3/4
`
`Ex. 1 104-0003
`
`Ex. 1104-0003
`
`

`

`
`
`7/25/2017 NCT00093782 on 2005_06_23: ClinicalTrials.gov Archive
`
`Administrative Data
`
`Organization name
`
`National Cancer Institute (NCI)
`
`Organization study ID CDR0000390249
`
`Secondary ID
`
`Secondary ID
`
`Secondary ID
`
`Sponsor
`Collaborator
`
`Health Authority
`
`PMH-PHL-021
`
`NCl-6171
`
`NCT00093782
`
`Princess Margaret Hospital
`
`National Cancer Institute (NCI)
`United States: Federal Government
`
`https://clinicaltrials.gov/archive/N CT00093782/2005_06_23
`
`4/4
`
`Ex. 1 104-0004
`
`Ex. 1104-0004
`
`