Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

• Sponsor: Spectrum Pharmaceuticals, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00606502
• Collaborator: (none)
• Enrollment: 201
• Locations: 47
• Arms: 2
• Duration (Months): 29.7
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Pralatrexate; Drug: Erlotinib; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jun 24, 2010
• Actual Study Completion Date: Jun 24, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pralatrexate Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).	Drug: Pralatrexate; Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications. Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications. Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.; Other Names: FOLOTYN PDX (RS)-10-propargyl-10-deazaaminopterin ; Dietary Supplement: Vitamin B12; 1 mg intramuscular injection Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment.; Other Names: Cyanocobalamin ; Dietary Supplement: Folic Acid; 1-1.25 mg orally Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.; Other Names: Vitamin B9 Folate Folacin
Active Comparator: Erlotinib 150 mg orally in tablet form Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.	Drug: Erlotinib; 150 mg orally in tablet form Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.; Other Names: Tarceva® Erlotinib hydrochloride ; Dietary Supplement: Vitamin B12; 1 mg intramuscular injection Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment.; Other Names: Cyanocobalamin ; Dietary Supplement: Folic Acid; 1-1.25 mg orally Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.; Other Names: Vitamin B9 Folate Folacin

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib [Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.]

   OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.

Secondary Outcome Measures

1. Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib [Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.]

   Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).

2. Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib [Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.]

   PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.

3. Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib [Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed Stage IIIB/ IV non-small cell lung cancer (NSCLC).

• Relapsed after treatment with 1 or 2 prior chemotherapy regimens, including at least 1 platinum-based treatment. Patients may have received pemetrexed as 1 of the prior therapies. Patients may not have received investigational therapy as their only prior therapy.

• Recovered from the toxic effects of prior therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Smoked ≥ 100 cigarettes in their lifetime, whether a former or current cigarette smoker.

• Adequate blood, liver and kidney function as defined by laboratory values.

• Received 1-1.25 mg daily oral folic acid for at least 7 days prior to randomization and 1 mg intramuscular injection of vitamin B12 within 10 weeks prior to randomization.

• Women of childbearing potential must use medically acceptable birth control and have a negative serum pregnancy test within 14 days prior to randomization. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test.

• Men who are not surgically sterile must use medically safe and effective birth control from the time of study randomization, and agree to continue practicing until at least 90 days after the last administration of study treatment.

• Accessible for repeat dosing and follow-up.

• Give written informed consent.

Exclusion Criteria:

• Active concurrent primary malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years. Patients with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no evidence of active or recurrent disease.

• Use of investigational drugs, biologics, or devices within 4 weeks prior to randomization.

• Previous exposure to pralatrexate or erlotinib.

• Women who are pregnant or breastfeeding.

• Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification.

• Uncontrolled hypertension.

• Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of <100 mm3 or detectable viral load within the past 3 months, and is receiving combination anti-retroviral therapy.

• Symptomatic central nervous system metastases or lesions for which treatment is required.

• Major surgery within 2 weeks of study randomization.

• Receipt of any conventional systemic chemotherapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C), or radiation therapy (RT) within 2 weeks, prior to randomization.

• Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.

• Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent or limit study compliance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Blood and Cancer Center	Bakersfield	California	United States	93309
2	Sharp Memorial Hospital	San Diego	California	United States	92123
3	Hematology Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida	United States	34952
4	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611
5	University of Kansas Cancer Center	Westwood	Kansas	United States	66205
6	Donald Berdeaux	Great Falls	Montana	United States	59405
7	Summit Medical Group	Berkeley Heights	New Jersey	United States	07922
8	Hematology and Oncology Associates South Jersey	Mount Holly	New Jersey	United States	08060
9	New York Oncology Hematology-Oncology Associates, P.C.	Latham	New York	United States	12110
10	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
11	New Bern Cancer Care	New Bern	North Carolina	United States	28562
12	Signal Point Clinical Research Center	Middletown	Ohio	United States	45042
13	Baptist Regional Cancer Center	Knoxville	Tennessee	United States	37920
14	Cancer Therapy and Research Center	San Antonio	Texas	United States	78229
15	Providence Everett Medical Center	Everett	Washington	United States	98201
16	Instituto Medico Especializado Alexander Fleming	Buenos Aires	Cuidad De Buenos Aires	Argentina	C1426ANZ
17	Policlinica Privada - Instituto de Medicina Nuclear	Bahia Blanca	Provincia De Buenos Aires	Argentina	B8000FJI
18	Hospital Britanico	Capital Federal		Argentina	C1280AEB
19	Centro Oncologico Rosario	Rosario		Argentina	S2000DSK
20	ISIS Clinica Especializada	Santa Fe		Argentina	S3000FFU
21	CAIPO (Centero Para la Atencion Integral del Paciente Oncologico)	Tucuman		Argentina	4000
22	Associação Hospital de Caridade de Ijuí	Ijui	RS	Brazil	98700-000
23	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS	Brazil	90035-903
24	Clinionco - Clínica de Oncologia de Porto Alegre	Porto Alegre	RS	Brazil	90430-090
25	Fundação Pio XII - Hospital do Câncer de Barretos	Barretos	SP	Brazil	14780-400
26	Biocancer S.A.	Belo Horizonte		Brazil	30150-270
27	Instituto do Cancer - Arnaldo Vieira de Carvalho	Sao Paulo		Brazil	01224-010
28	Masarykuv onkologicky ustav	Brno		Czechia	656 53
29	Palacký University Medical School and Teaching Hospital	Olomouc		Czechia	775 20
30	Vitkovicka nemocnice, a. s.	Ostrava		Czechia	703 84
31	Fakultni nemocnice na Bulovce	Praha 8		Czechia	180 00
32	Fakultni nemocnice v Motole	Praha		Czechia	150 06
33	Nemocnice Na Homolce	Praha		Czechia	15003
34	National Koranyi TBC and Pulmonology Institute	Budapest	Pest	Hungary	1525
35	Jósa András Teaching Hospital	Nyiregyhaza	Szabolcs-Szatmár-Bereg	Hungary	4412
36	Vas County Markusovszky Hospital	Szombathely	Vas	Hungary	9700
37	Zala County Hospital	Zalaegerszeg	Zala	Hungary	8900
38	Matrai Allami Gyogyintezet	Matrahaza		Hungary	3233
39	Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza	Tatabánya		Hungary	2800
40	MNJ Radium Hospital and Radium Institute of Oncology and Regional Cancer Centre	Hyderabaad	Andhra Pradesh	India	500004
41	Indo American Cancer Institute and Research Center	Hyderabad	Andhra Pradesh	India	500034
42	Kidwai Memorial Institute of Oncology	Bangalore	Karnataka	India	560029
43	Regional Cancer Center	Trivandrum	Kerala	India	695011
44	Tata Memorial Hospital	Mumbai	Maharashtra	India	400012
45	Jehangir Clinical Development Centre Pvt Ltd	Pune	Mahara	India	411001
46	B.P. Poddar Cancer Institute	Kolkata	West Bengal	India	700053
47	Dharmashila Cancer Hospital & Research Centre	New Delhi		India	110096

Sponsors and Collaborators

• Spectrum Pharmaceuticals, Inc

Investigators

• Study Director: Garry Weems, PharmD, Spectrum Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spectrum Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT00606502
• Other Study ID Numbers: PDX-012; 2007-004673-26
• First Posted: Feb 4, 2008
• Last Update Posted: Mar 5, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Spectrum Pharmaceuticals, Inc: Stage IIIB/IV non-small cell lung cancer; Non-small cell lung cancer; NSCLC; Lung Cancer; Pralatrexate; Erlotinib; Tarceva; PDX; Smoking; Smoker
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin; Vitamin B Complex; Erlotinib Hydrochloride; 10-deazaaminopterin

Study Results

Participant Flow

Recruitment Details	Patients were enrolled between January 2008 and June 2009 across 43 study sites in 6 countries.

Arm/Group Title	Pralatrexate	Erlotinib
Arm/Group Description	190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)	150 mg tablet taken orally daily
Period Title: Randomization
STARTED	100	101
COMPLETED	97	101
NOT COMPLETED	3	0
Period Title: Randomization
STARTED	97	101
COMPLETED	97	98
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Pralatrexate	Erlotinib	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	100	101	201
Age, Customized (participants) [Number]
Between 18 and 65 years	58 58%	60 59.4%	118 58.7%
>=65 years	42 42%	41 40.6%	83 41.3%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	63.0 (9.0)	62.0 (9.1)	63.0 (9.0)
Sex: Female, Male (Count of Participants)
Female	31 31%	33 32.7%	64 31.8%
Male	69 69%	68 67.3%	137 68.2%
Region of Enrollment (participants) [Number]
United States	31 31%	37 36.6%	68 33.8%
Czech Republic	17 17%	20 19.8%	37 18.4%
Hungary	17 17%	15 14.9%	32 15.9%
India	11 11%	12 11.9%	23 11.4%
Brazil	13 13%	9 8.9%	22 10.9%
Argentina	11 11%	8 7.9%	19 9.5%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib
Description	OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.
Time Frame	Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pralatrexate	Erlotinib
Arm/Group Description
Measure Participants	100	101
Median (95% Confidence Interval) [Months Survival]	6.7	7.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pralatrexate, Erlotinib
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.61 to 1.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib
Description	Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).
Time Frame	Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.

Outcome Measure Data

Analysis Population Description

Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.

Arm/Group Title	Pralatrexate	Erlotinib
Arm/Group Description
Measure Participants	97	98
Complete + Partial Response	2 2%	7 6.9%
Complete Response (CR)	0 0%	1 1%
Partial Response (PR)	2 2%	6 5.9%
Stable Disease (SD)	33 33%	35 34.7%
Progressive Disease (PD)	29 29%	36 35.6%
Disease Control (CR+PR+SD)	35 35%	42 41.6%
Unable to Evaluate	2 2%	0 0%
Missing (off or no treatment, not confirmed)	31 31%	20 19.8%

3. Secondary Outcome

Title	Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib
Description	PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.
Time Frame	Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.

Outcome Measure Data

Analysis Population Description

Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.

Arm/Group Title	Pralatrexate	Erlotinib
Arm/Group Description
Measure Participants	100	101
Median (95% Confidence Interval) [months]	3.4	2.8

4. Secondary Outcome

Title	Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
Time Frame	Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).

Outcome Measure Data

Analysis Population Description

Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term. Grade 3 = Severe Grade 4 = Life-threatening or disabling

Arm/Group Title	Pralatrexate	Erlotinib
Arm/Group Description
Measure Participants	97	101
At least one AE	75 75%	77 76.2%
Grade 3 AEs	25 25%	18 17.8%
Grade 4 AEs	5 5%	0 0%
At least one SAE	14 14%	2 2%

Adverse Events

Time Frame	Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).
Adverse Event Reporting Description	Events reported for all patients who received at least one dose of Pralatrexate or Erlotinib.
Arm/Group Title	Pralatrexate		Erlotinib
Arm/Group Description
All Cause Mortality
	Pralatrexate		Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pralatrexate		Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/97 (32%)		32/101 (31.7%)
Blood and lymphatic system disorders
thrombocytopenia	4/97 (4.1%)		0/101 (0%)
leukopenia	3/97 (3.1%)		0/101 (0%)
anaemia	2/97 (2.1%)		0/101 (0%)
neutropenia	1/97 (1%)		0/101 (0%)
pancytopenia	1/97 (1%)		0/101 (0%)
Cardiac disorders
pericardial effusion	1/97 (1%)		2/101 (2%)
atrial fibrillation	1/97 (1%)		1/101 (1%)
cardio-respiratory arrest	1/97 (1%)		1/101 (1%)
Gastrointestinal disorders
stomatitis	9/97 (9.3%)		0/101 (0%)
abdominal pain	0/97 (0%)		3/101 (3%)
diarrhoea	1/97 (1%)		1/101 (1%)
gastrointestinal haemorrhage	1/97 (1%)		1/101 (1%)
vomiting	0/97 (0%)		2/101 (2%)
anal inflammation	1/97 (1%)		0/101 (0%)
dysphagia	0/97 (0%)		1/101 (1%)
nausea	0/97 (0%)		1/101 (1%)
General disorders
pyrexia	2/97 (2.1%)		4/101 (4%)
asthenia	0/97 (0%)		1/101 (1%)
fatigue	1/97 (1%)		0/101 (0%)
multimorbidity	1/97 (1%)		0/101 (0%)
non-cardiac chest pain	0/97 (0%)		1/101 (1%)
sudden death	1/97 (1%)		0/101 (0%)
Hepatobiliary disorders
bile duct obstruction	1/97 (1%)		0/101 (0%)
hyperbilirubinaemia	1/97 (1%)		0/101 (0%)
Infections and infestations
sepsis	3/97 (3.1%)		3/101 (3%)
pneumonia	2/97 (2.1%)		3/101 (3%)
respiratory tract infection	1/97 (1%)		1/101 (1%)
chest wall abscess	0/97 (0%)		1/101 (1%)
infection	1/97 (1%)		0/101 (0%)
influenza	1/97 (1%)		0/101 (0%)
pulmonary sepsis	0/97 (0%)		1/101 (1%)
septic shock	1/97 (1%)		0/101 (0%)
urosepsis	0/97 (0%)		1/101 (1%)
Injury, poisoning and procedural complications
femur fracture	1/97 (1%)		1/101 (1%)
Metabolism and nutrition disorders
dehydration	1/97 (1%)		4/101 (4%)
anorexia	0/97 (0%)		1/101 (1%)
hypoglycaemia	0/97 (0%)		1/101 (1%)
hyponatraemia	1/97 (1%)		0/101 (0%)
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain	1/97 (1%)		2/101 (2%)
arthralgia	1/97 (1%)		0/101 (0%)
back pain	0/97 (0%)		1/101 (1%)
flank pain	0/97 (0%)		1/101 (1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer pain	0/97 (0%)		1/101 (1%)
renal cell carcinoma	0/97 (0%)		1/101 (1%)
Nervous system disorders
convulsion	1/97 (1%)		3/101 (3%)
cerebral infarction	0/97 (0%)		1/101 (1%)
headache	1/97 (1%)		0/101 (0%)
Psychiatric disorders
confusional state	1/97 (1%)		0/101 (0%)
Respiratory, thoracic and mediastinal disorders
dyspnoea	5/97 (5.2%)		4/101 (4%)
respiratory failure	5/97 (5.2%)		1/101 (1%)
haemoptysis	1/97 (1%)		1/101 (1%)
hypoxia	1/97 (1%)		1/101 (1%)
acute respiratory distress syndrome	1/97 (1%)		0/101 (0%)
aspiration	0/97 (0%)		1/101 (1%)
pleural effusion	0/97 (0%)		1/101 (1%)
pneumonitis	1/97 (1%)		0/101 (0%)
pneumothorax	0/97 (0%)		1/101 (1%)
respiratory distress	1/97 (1%)		0/101 (0%)
Vascular disorders
arterial thrombosis	0/97 (0%)		1/101 (1%)
deep vein thrombosis	1/97 (1%)		0/101 (0%)
hypotension	1/97 (1%)		0/101 (0%)
Other (Not Including Serious) Adverse Events
	Pralatrexate		Erlotinib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/97 (93.8%)		94/101 (93.1%)
Blood and lymphatic system disorders
anaemia	20/97 (20.6%)		12/101 (11.9%)
thrombocytopenia	12/97 (12.4%)		1/101 (1%)
Eye disorders
conjunctivitis	6/97 (6.2%)		5/101 (5%)
Gastrointestinal disorders
stomatitis	62/97 (63.9%)		4/101 (4%)
diarrhoea	15/97 (15.5%)		32/101 (31.7%)
nausea	12/97 (12.4%)		17/101 (16.8%)
vomiting	10/97 (10.3%)		10/101 (9.9%)
constipation	3/97 (3.1%)		8/101 (7.9%)
General disorders
fatigue	25/97 (25.8%)		16/101 (15.8%)
asthenia	15/97 (15.5%)		8/101 (7.9%)
oedema peripheral	5/97 (5.2%)		7/101 (6.9%)
Infections and infestations
bronchitis	5/97 (5.2%)		8/101 (7.9%)
Investigations
weight decreased	8/97 (8.2%)		10/101 (9.9%)
Metabolism and nutrition disorders
anorexia	16/97 (16.5%)		19/101 (18.8%)
hypokalaemia	5/97 (5.2%)		8/101 (7.9%)
Musculoskeletal and connective tissue disorders
back pain	3/97 (3.1%)		10/101 (9.9%)
musculoskeletal pain	4/97 (4.1%)		9/101 (8.9%)
Respiratory, thoracic and mediastinal disorders
dyspnoea	12/97 (12.4%)		22/101 (21.8%)
cough	11/97 (11.3%)		17/101 (16.8%)
Skin and subcutaneous tissue disorders
dermatitis acneiform	4/97 (4.1%)		28/101 (27.7%)
rash maculo-papular	4/97 (4.1%)		21/101 (20.8%)
dry skin	2/97 (2.1%)		9/101 (8.9%)

Limitations/Caveats

The date of the CRF database cut-off for patients (no further case report form or query data entry) was 24 Jun 2010. As of the CRF data cut-off date, 3 patients, remained on therapy.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Allos agreements with investigators (PIs) may vary. The PI may publish/make public data from the study after the earlier of publication by Allos or 24 months after database lock. Allos is allowed 60 days to review and comment on the communication prior to public release. Allos can request removal of confidential information (other than study results).