A Study to Evaluate the Safety and Efficacy of Anamorelin HCL in Patients with Non Small Cell Lung Cancer
Scientific Title of Study
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NCT00622193
ClinicalTrials.gov
ST-ANAM-207
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Prashant Pandya
Designation
DGM - Clinical Operations
Affiliation
Reliance Life Sciences Pvt. Ltd.
Address
Reliance Clinical Research Services (RCRS), DALC, R-282, TTC Area of MIDC,
Note: No upper age limit for this clinical trial, (indicated as 18 years
and above)
1. Must have histologically or cytologically documented Non-Small Cell Lung Cancer (NSCLC)
2. Acceptable histologic forms of NSCLC are squamous, large cell, bronchioloalveolar, or adenocarcinoma including intermediate forms
Protocol Amendment No 3, approval received dated 11th Feb 2010 and is uploaded in the approval field.
Inclusion Criteria:
1. Must have histologically or cytologically documented Non-Small Cell Lung
Cancer (NSCLC)
2. Acceptable histologic forms of NSCLC are squamous, large cell,
bronchioloalveolar, or adenocarcinoma including intermediate forms
3. Must be eligible for treatment with paclitaxel and carboplatin +/- bevacizumab
4. Must be at least 18 years of age
5. Must have stage “wet†IIIB disease (any T, N3, M0 or T4, any N, M0, with
malignant pleural or pericardial effusion) or stage IV (any T, any N, M1) disease
by AJCC criteria
6. Prior diagnostic or therapeutic surgery is allowed so long as the wound has fully
healed the patient has fully recovered from the procedure and at least 3 weeks
have elapsed from the procedure and the start (Cycle 1, Day 1) of protocol
therapy (3-week recovery requirement does not apply to needle biopsy or other
minimally invasive procedures such as chest tube placement or VATS
pleurodesis)
7. Prior radiotherapy is allowed for local symptom palliation prior to the start of
treatment so long as no more than 1/3rd of the marrow bearing bone has been
radiated, the patient has fully recovered from the procedure and at least 3 weeks
have elapsed from the procedure and the start of protocol therapy
(see Appendix V)
8. Measurable disease by the Response Evaluation Criteria in Solid Tumors
(RECIST) criteria must be present
9. ECOG performance status must be 0 or 1
10. Life expectancy of at least 3 months from the start of protocol therapy
(Cycle 1, Day 1)
11. Patient must be able to receive care as an outpatient at the time of entry
12. Adequate marrow function defined as an absolute neutrophil count (ANC) of
1,500/cmm or more without growth factor treatment, a platelet count of
150,000/cmm or more and a hemoglobin of at least 9 g/dL without transfusion or
growth factor support
13. Adequate hepatic function. Liver aminotransferases AST (SGOT) and ALT
(SGPT) not more than 2.5-fold the upper limit of normal; total bilirubin not more
than 1.5-fold the upper limit of normal. (These values reflect the upper limit of
CTC Grade-1 toxicity based on laboratory reference ranges) [Kratz 2004].
14. Adequate renal function. Creatinine level must be no more than 2.25 mg/dl (200
μmol/liter)
15. Women and men of child bearing/conceiving potential must be willing to use
adequate contraceptive procedures during the course of the study
16. Women of child bearing potential (e.g. not surgically sterilized or two years postmenopausal)
must have a negative beta-hCG pregnancy test at study entry
17. Must be willing and able, in the opinion of the investigator, to comply with the
protocol tests and procedures
18. Must be willing and able to give signed informed consent.
ExclusionCriteria
Details
1. Patients who have mesothelioma, small cell carcinoma or any histologic type not included in the inclusion criteria. Mixed large and small cell histologies are not allowed
2. Patients with uncontrolled CNS metastases or receiving dexamethasone for CNS disease. Minimal disease not requiring immediate treatment or not expected to need treatment in the next 2 months are allowed
3. Women who are pregnant or breast feeding are excluded
4. Patients receiving a concurrent investigational agent
5. Patients with any concomitant medical or psychiatric condition or social situation that would make it difficult to comply with protocol requirements, including the inability to comply with handgrip strength determinations in both hands.
Protocol Amendment No 3, approval received dated 11th Feb 2010 and is uploaded in the approval field.
Exclusion Criteria
1. Patients who have mesothelioma, small cell carcinoma or any histologic type not
included in the inclusion criteria. Mixed large and small cell histologies are not
allowed
2. Patients with prior chemotherapy for this disease. Patients who received prior
adjuvant chemotherapy for early stage disease or prior chemotherapy for Stage III
disease and then have relapsed with Stage IV disease may participate provided
that at least 4 weeks have lapsed since prior chemotherapy and the patient has not
yet received their first dose of chemotherapy for the “wet†IIIB/IV disease
qualifying the patient for the present study.
3. Patients with a prior malignancy (except for cervical cancer or basal cell
carcinoma) treated at least 5 years before study entry and without evidence of
recurrence since that time
4. Patients with uncontrolled CNS metastases or receiving dexamethasone for CNS
disease. Minimal disease not requiring immediate treatment or not expected to
need treatment in the next 2 months are allowed
5. Women who are pregnant or breast feeding are excluded
6. Patients with active infections, including HIV disease
7. Patients with untreated hypo- or hyperthyroidism as assessed by screening TSH.
8. Patients receiving strong CYP3A4 inhibitors (itraconazole, ketoconazole, or
clarithromycin), megestrol acetate, anabolic steroids, high dose steroids (20 mg of
prednisone/day equivalent or more) or any other agent to increase appetite or
weight such as growth hormone (GH), insulin-like growth factor 1 (IGF-1),
insulin like growth factor binding protein-3 (IGFBP-3), growth hormonereleasing
hormone, or cannabinoids. Patients must have discontinued these
medications for at least 6 weeks prior to Cycle 1, Day 1 and throughout the study
duration.
9. Patients receiving tube feedings or parenteral nutrition (either total or partial).
Patients must have discontinued these treatments for at least 6 weeks prior to
Cycle 1, Day 1 and throughout the study duration.
10. Patients with uncontrolled or brittle diabetes
11. Patients with physiologic or psychological eating disorders
12. Patients with significant obesity, BMI 30 at screening
13. Patients receiving a concurrent investigational agent
14. Patients with known hypersensitivity to carboplatin or paclitaxel or any of their
components (e.g. cremophor EL)
15. Patients with any concomitant medical or psychiatric condition or social situation
that would make it difficult to comply with protocol requirements, including the
inability to comply with handgrip strength determinations in both hands; for
example, pre-existing neurological impairment.
16. Patients who do not meet or exceed the 7 kg handgrip strength threshold in each
hand in at least one of three consecutive measurements in each hand at Screening
(see Flowchart).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Changes from baseline in handgrip strength and body weight. Timeline: May 2008 to December 2009
May 2008 to December 2009
Secondary Outcome
Outcome
TimePoints
Anamorelin pharmacokinetic data. Timeline: May 2008 to December 2009
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The clinical study is being conducted in USA and India. It is currently recruiting patients across 27 sites participating in the study from USA. India is the only other participating country. Sponsor proposes to enroll up to 228 patients between two countries.
This is a double-blind, parallel-group, placebo-controlled outpatient study. Patients will be randomized 1:1:1 to receive anamorelin HCl at 50 mg, 100 mg, or placebo daily for twelve weeks. A central randomization system will be used and eligible patients will be stratified based on concomitant use of bevacizumab (+/-).