NSCLCPhase 2NCT00866970
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
A Phase 2 study testing ALD518 and Infusion of 0.9% Saline without ALD518 in people with NSCLC and Fatigue, run by CSL Behring at 43 sites in 9 countries.
Trial summary
The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ALD518 and Infusion of 0.9% Saline without ALD518
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 43 sitesin 9 countries
- Study dates
- Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of NSCLC incurable by other treatments including surgery
- A ≥5 % loss of body weight in the preceding 3 months
- A C-reactive protein (CRP) concentration ≥ 10 mg/L
- Life Expectancy of at least 12 weeks
Who cannot join
- Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
- AST/ALT ≥ 3 x ULN at screening
- Hemoglobin < 8 g/dL at Screening
- History of or active diagnosis of Tuberculosis
Trial locations and contacts
43 sites in 9 countries.
43 sites in 9 countries
India13 sites
Kidwai Memorial Institute of Oncology
Bangalore, 560029
Kailash Cancer Hospital and Research Centre
Gujarat, 391760
IndoAmerican Cancer Institute & Research Center
Hyderabad, 500034
SEAROC Cancer Centre
Jaipur, 302013
Orchid Nursing Home
Kolkata, 700 054
Tata Memorial Hospital
Mumbai, 400 012
Shatabdi Hospital
Mumbai
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422 304
Dr. Kamakshi Memorial Hospital
Pallikaranai, Chennai, 600100
GKNM Hospital
Pappanaickenpalayam, Coimbatore, 641037
Indira Gandhi Institute of Medical Sciences
Patna, Bihar
Mahavir Cancer Sansthan
Patna, 801505
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, 411 001
Russia7 sites
Territorial Clinical Oncology Dispensary
Krasnodar, Krasnodar Territory, 350040
City Clinical Hospital No. 1
Novosibirsk, 630047
Stavropol Territorial Clinical
Pyatigorsk, Stavropol Territory, 357500
Saint-Petersburg State Medical University, I.P. Pavlov
Saint Petersburg, 197022
St. Petersburg City Oncology Dispensary
Saint Petersburg, 198255
Republic Oncology Dispensary
Ufa, Bashkortostan Republic, 450054
Yaroslavl Regional clinical Oncology Hospital
Yaroslavl, 150054
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Rivercity Hospital Research Centre
Auchenflower, Queensland, 4066
Australian Clinical Research Organisation
Kippa-Ring, Queensland, 4021
Palliative Care Launceston General Hospital
Launceston, Tasmania, 7250
Poland4 sites
Oddzial Chorob Pluc i Leczenia Raka Pluc
Bydgoszcz, 85-326
Oddzial Chemioterapii Szpital Morski
Gdynia, 81-519
II Oddzia Chorob Pluc z Pododdzialem Chemioterapii
Krakow, 31-202
Oddzial II Chemioterapii Specjalistyczny Szpital
Szczecin, 70-891
Romania4 sites
Professor Dr. Al Trestioreanu Institute
Bucharest, 022328
Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy
Cluj-Napoca, 400015
Oradea Clinical County Hospital Medical Oncology Department
Oradea, 410032
County Hospital Sibiu Medical Oncology Department
Sibiu, 550245
Serbia4 sites
Institute of Lung Diseases and TB
Belgrade, 11 000
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080
Clinical Centre Kragujevac
Kragujevac, 34000
Institute for Pulmonary diseases of Vojvodina
Sremska, 21 104
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
McGill University, Department of Oncology
Montreal, Quebec, H2W 1S6
Atlantic Health Sciences Corporation
Saint John, New Brunswick, E2l 4L2
Georgia3 sites
A. Gvamichava National Cancer Centre
Tbilisi, 0177
Union Cancer Prevention Centre
Tbilisi, 0177
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186
About this study
Official title: A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia
The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).
Read the detailed description
This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia.
It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio.
A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24.
Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1.
Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.
- Being tested
- ALD518, Infusion of 0.9% Saline without ALD518
- Keywords
- Lung Cancer, Fatigue, Cachexia
- Medical subject headings
- Fatigue, Cachexia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALD518Biological
ALD518 80 mg on Day 1, Week 8 and Week 16
ALD518Biological
ALD518 160 mg IV on Day 1, Week 8 and Week 16
ALD518Biological
ALD518 360 mg IV on Day 1, Week 8, and Week 16
Infusion of 0.9% Saline without ALD518Biological
Infusion of 0.9% Saline without addition of ALD518
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ALD518 Receives: Biological: ALD518 |
| 2 | Experimental | ALD518 Receives: Biological: ALD518 |
| 3 | Experimental | ALD518 Receives: Biological: ALD518 |
| 4 | Placebo comparator | No ALD518 Receives: Biological: Infusion of 0.9% Saline without ALD518 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Safety parameters.
Measured: 20 weeks
Secondary outcomes (1)
Time to symptomatic progressions at Weeks 12 and 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionAug 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 NSCLCStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey TL Smith, MD FRCP, Study director, Alder Biopharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866970
- Sponsor's protocol ID
- ALD518-CLIN-004
- Status last verified
- Sep 2017
- First submitted
- 20 Mar 2009
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia
- ClinicalTrials.gov ID
- NCT00866970
- Acronym / sponsor ID
- ALD518-CLIN-004
- Keywords
- Lung Cancer, Fatigue, Cachexia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Mar 2009 (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 asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).
Detailed description
This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia.
It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio.
A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24.
Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1.
Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ALD518ALD518 |
| 2 | Experimental | Biological: ALD518ALD518 |
| 3 | Experimental | Biological: ALD518ALD518 |
| 4 | Placebo comparator | Biological: Infusion of 0.9% Saline without ALD518No ALD518 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of NSCLC incurable by other treatments including surgery
- A ≥5 % loss of body weight in the preceding 3 months
- A C-reactive protein (CRP) concentration ≥ 10 mg/L
- Life Expectancy of at least 12 weeks
Key exclusion criteria (4 listed)
- Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
- AST/ALT ≥ 3 x ULN at screening
- Hemoglobin < 8 g/dL at Screening
- History of or active diagnosis of Tuberculosis
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 |
|---|---|---|
| ALD518ALD518 80 mg on Day 1, Week 8 and Week 16 | Biological | 1 |
| ALD518ALD518 160 mg IV on Day 1, Week 8 and Week 16 | Biological | 2 |
| ALD518ALD518 360 mg IV on Day 1, Week 8, and Week 16 | Biological | 3 |
| Infusion of 0.9% Saline without ALD518Infusion of 0.9% Saline without addition of ALD518 | Biological | 4 |
Primary outcome
Change in Safety parameters.
Time frame: 20 weeks
1 secondary outcome
Time to symptomatic progressions at Weeks 12 and 24
Time frame: 24 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 9 Jul 2020.
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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.
Jeffrey TL Smith, MD FRCP study director
Alder Biopharmaceuticals, Inc.
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALD518 and Infusion of 0.9% Saline without ALD518 in people with NSCLC and Fatigue, run by CSL Behring at 43 sites in 9 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 4 inclusion and 4 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in India, Russia, Australia, Poland, Romania and 4 more countries. 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?
Change in Safety parameters. (time frame: 20 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 9 Jul 2020.