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Anamorelin HCI in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): An Extension Study – ROMANA 3
- To evaluate the safety and tolerability of Anamorelin HCl.
- To evaluate the effect of Anamorelin HCl on body weight
- To evaluate the effect of Anamorelin HCl on muscle strength as measured by HGS
- To evaluate the effect of Anamorelin HCl on quality of life as assessed using the FACIT-F (Functional Assessment of Chronic Illness Therapy � Fatigue) and the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) (see Appendix III)
- To evaluate the effect of Anamorelin HCl on quality of life as assessed using the Hunger Assessment Scale (see Appendix IV)
- The patient has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and the Investigator considers the patient to be appropriate to continue to receive an additional 12 weeks of study drug administration. The patient must start dosing on the extension study within 5 days of completing dosing on the original trial.
- Females and males at least 18 years of age
- ECOG performance status ≤ 2 (see Appendix I)
- Estimated life expectancy of > 4 months at the time of screening
- If the patient is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method).
- The patient must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
- Women who are pregnant or breast-feeding
- Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period.
- Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol.
- Patients unable to readily swallow oral tablets. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded.
- Has an active, uncontrolled infection
- Has known or symptomatic brain metastases
- Patients receiving strong CYP3A4 inhibitors (see Appendix VI)
- Patients receiving tube feedings or parenteral nutrition (either total or partial). Patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
- Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
- Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl
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