Carcinoma, Non-Small-Cell LungPhase 2NCT00622193
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
A Phase 2 study testing anamorelin HCl in people with Carcinoma, Non-Small-Cell Lung, run by Helsinn Therapeutics (U.S.), Inc at 33 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- anamorelin HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage IIIB or IV NSCLC
- eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab
Who cannot join
- mixed large and small cell histologies for lung cancer
- significant obesity, BMI > 30
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States19 sites
Augusta Oncology Associates
Augusta, Georgia, 30901
John Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Center
Boston, Massachusetts, 02115
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The West Clinic
Corinth, Mississippi, 38834
Duke University Medical Center
Durham, North Carolina, 27710
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29926
Baylor College of Medicine/VAMC
Houston, Texas, 77030
The Methodist Hospital Research Institute
Houston, Texas, 77030
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46260
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Osler Medical
Melbourne, Florida, 32901
The West Clinic
Memphis, Tennessee, 38120
North West Medical Specialties, PLLC
Puyallup, Washington, 98372
The West Clinic
Southaven, Mississippi, 38671
Washington University School of Medicine
St Louis, Missouri, 63110
South Georgia Medical Center
Valdosta, Georgia, 31602
India14 sites
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal
Kamakshi Memorial Hospital
Chennai
Dharamshila Cancer Hospital and Research Center
Delhi
SEAROC Cancer Center
Jaipur, Rajasthan
Bhagwan Mahaveer Cancer Hospital and Resaerch Center
Jaipur
Birla Cancer Centre SMS Medical College Hospital
Jaipur
Kodlikeri Memorial Hospital
Maharashtra
Jaslok Hospital and Research Centre
Mumbai
Shatabdi Super Speciality Hospital
Mumbai Naka, Nasik
Cancer Clinic 208
Nagpur, Maharashtra
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
Patna, Bihar
Noble Hospital
Pune, Maharashtra
Ruby Hall Clinic
Pune, Maharashtra
Kaushalya Medical Foundation Trust Hospital
Thane, Maharashtra
About this study
Official title: 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
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
Read the detailed description
Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- anamorelin HCl, placebo
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anamorelin HClDrug
Also called ST-1291
50 mg tablet
anamorelin HClDrug
Also called ST-1291
100 mg tablet
placeboDrug
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 Active 50 mg | Experimental | Not described Receives: Drug: anamorelin HCl |
| 2 Active 100 mg | Experimental | Not described Receives: Drug: anamorelin HCl |
| 3 Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength and body weight
Measured: Twelve weeks
Secondary outcomes (1)
Quality of Life and Biomarker
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Therapeutics (U.S.), Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Temel, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622193
- Sponsor's protocol ID
- ST-ANAM-207
- Status last verified
- Apr 2017
- First submitted
- 12 Feb 2008
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00622193
- Acronym / sponsor ID
- ST-ANAM-207
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Helsinn Therapeutics (U.S.), IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
Detailed description
Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Active 50 mg | Experimental | Drug: anamorelin HCl |
| 2 Active 100 mg | Experimental | Drug: anamorelin HCl |
| 3 Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stage IIIB or IV NSCLC
- eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab
Key exclusion criteria (2 listed)
- mixed large and small cell histologies for lung cancer
- significant obesity, BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anamorelin HClAlso: ST-129150 mg tablet | Drug | 1 Active 50 mg |
| anamorelin HClAlso: ST-1291100 mg tablet | Drug | 2 Active 100 mg |
| placeboplacebo tablet | Drug | 3 Placebo |
Primary outcome
Hand grip strength and body weight
Time frame: Twelve weeks
1 secondary outcome
Quality of Life and Biomarker
Time frame: Twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Temel, MD study director
Massachusetts General Hospital
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anamorelin HCl in people with Carcinoma, Non-Small-Cell Lung, run by Helsinn Therapeutics (U.S.), Inc at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength and body weight (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.