Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia

Sponsor

CSL Behring (Industry)

Overall Status

Completed

CT.gov ID

NCT00866970

Collaborator

(none)

124

Enrollment

Locations

Arms

Duration (Months)

2.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
NSCLC Fatigue Cachexia	Biological: ALD518 Biological: ALD518 Biological: ALD518 Biological: Infusion of 0.9% Saline without ALD518	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ALD518	Biological: ALD518 ALD518 80 mg on Day 1, Week 8 and Week 16
Experimental: 2 ALD518	Biological: ALD518 ALD518 160 mg IV on Day 1, Week 8 and Week 16
Experimental: 3 ALD518	Biological: ALD518 ALD518 360 mg IV on Day 1, Week 8, and Week 16
Placebo Comparator: 4 No ALD518	Biological: Infusion of 0.9% Saline without ALD518 Infusion of 0.9% Saline without addition of ALD518

Outcome Measures

Primary Outcome Measures

Change in Safety parameters. [20 weeks]

Secondary Outcome Measures

Time to symptomatic progressions at Weeks 12 and 24 [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rivercity Hospital Research Centre	Auchenflower	Queensland	Australia	4066
2	Australian Clinical Research Organisation	Kippa Ring	Queensland	Australia	4021
3	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
4	Palliative Care Launceston General Hospital	Launceston	Tasmania	Australia	7250
5	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
6	Atlantic Health Sciences Corporation	Saint John	New Brunswick	Canada	E2l 4L2
7	McGill University, Department of Oncology	Montreal	Quebec	Canada	H2W 1S6
8	A. Gvamichava National Cancer Centre	Tbilisi		Georgia	0177
9	Union Cancer Prevention Centre	Tbilisi		Georgia	0177
10	Medulla Chemotherapy and Immunotherapy Clinic	Tbilisi		Georgia	0186
11	Indira Gandhi Institute of Medical Sciences	Patna	Bihar	India
12	Dr. Kamakshi Memorial Hospital	Pallikaranai	Chennai	India	600100
13	GKNM Hospital	Pappanaickenpalayam	Coimbatore	India	641037
14	Curie Manavata Cancer Centre	Nasik	Maharashtra	India	422 304
15	Kidwai Memorial Institute of Oncology	Bangalore		India	560029
16	Kailash Cancer Hospital and Research Centre	Gujarat		India	391760
17	IndoAmerican Cancer Institute & Research Center	Hyderabad		India	500034
18	SEAROC Cancer Centre	Jaipur		India	302013
19	Orchid Nursing Home	Kolkata		India	700 054
20	Tata Memorial Hospital	Mumbai		India	400 012
21	Shatabdi Hospital	Mumbai		India
22	Mahavir Cancer Sansthan	Patna		India	801505
23	Jehangir Clinical Development Centre Pvt. Ltd.	Pune		India	411 001
24	P3 Research LTD	Tauranga		New Zealand	31-40
25	Oddzial Chorob Pluc i Leczenia Raka Pluc	Bydgoszcz		Poland	85-326
26	Oddzial Chemioterapii Szpital Morski	Gdynia		Poland	81-519
27	II Oddzia Chorob Pluc z Pododdzialem Chemioterapii	Krakow		Poland	31-202
28	Oddzial II Chemioterapii Specjalistyczny Szpital	Szczecin		Poland	70-891
29	Professor Dr. Al Trestioreanu Institute	Bucharest		Romania	022328
30	Professor Dr. I Chiricuta Institute of Oncology and Radiotherapy	Cluj-Napoca		Romania	400015
31	Oradea Clinical County Hospital Medical Oncology Department	Oradea		Romania	410032
32	County Hospital Sibiu Medical Oncology Department	Sibiu		Romania	550245
33	Territorial Clinical Oncology Dispensary	Krasnodar	Krasnodar Territory	Russian Federation	350040
34	Republic Oncology Dispensary	Ufa	Republic Of Bashkortostan	Russian Federation	450054
35	Stavropol Territorial Clinical	Pyatigorsk	Stavropol Territory	Russian Federation	357500
36	City Clinical Hospital No. 1	Novosibirsk		Russian Federation	630047
37	Saint-Petersburg State Medical University, I.P. Pavlov	Saint-Petersburg		Russian Federation	197022
38	St. Petersburg City Oncology Dispensary	Saint-Petersburg		Russian Federation	198255
39	Yaroslavl Regional clinical Oncology Hospital	Yaroslavl		Russian Federation	150054
40	Institute of Lung Diseases and TB	Belgrade		Serbia	11 000
41	Clinical Hospital Center Bezanijska Kosa	Belgrade		Serbia	11080
42	Clinical Centre Kragujevac	Kragujevac		Serbia	34000
43	Institute for Pulmonary diseases of Vojvodina	Sremska		Serbia	21 104