Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395914
• Other study ID #: HT-ANAM-303
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2011
• Last updated: August 17, 2015
• Start date: July 2011
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Helsinn Therapeutics (U.S.), Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

Description:

This is a randomized, double-blind, parallel-group, placebo-controlled, extension study to assess the safety and efficacy of Anamorelin HCl in NSCLC-C patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial

• ECOG performance status =2

• Life expectancy of >4 months at time of screening

• If 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)

• 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

Exclusion Criteria:

• 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

• Inability 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

• Receiving strong CYP3A4 inhibitors

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Anamorelin HCl

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Therapeutics (U.S.), Inc

Countries where clinical trial is conducted

United States,  Australia,  Belarus,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Russian Federation,  Serbia,  Slovenia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and tolerability of Anamorelin	Incidence of adverse events (assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 [NCI CTCAE Version 4]) and Vital signs, electrocardiogram (ECG), and safety laboratory assessments will be assessed.	12 weeks	Yes
Secondary	Evaluate the effect of Anamorelin on body weight	Changes in body weight from baseline of the HT-ANAM-301 or HT-ANAM-302 trials to Weeks 4, 8, and 12.	12 weeks	No
Secondary	Evaluate the effect of Anamorelin on muscle strength as measured by hand-grip strength (HGS)	Change in HGS of the non-dominant hand and percent change from baseline of the original trials to Weeks 8 and 12.	12 weeks	No
Secondary	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)	Quality of life as assessed by FACIT-F and FAACT at baseline of the original trials compared to Weeks 4, 8, and 12.	12 weeks	No