ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00836888

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

Condition or Disease	Intervention/Treatment	Phase
Malignant Solid Tumor	Biological: ONO-4538	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort	Biological: ONO-4538 1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Arm

Intervention/Treatment

Experimental: Cohort

Biological: ONO-4538

1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Outcome Measures

Primary Outcome Measures

Cmax at Single Dose [day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation]
AUClast at Single Dose [day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation]
T1/2 at Single Dose [day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation]
Ceoi at Multiple Doses [day 15]
Ceoi：Serum concentrations immediately after the end of continuous administration

Secondary Outcome Measures

Best Overall Response [up to study completion, every 4 weeks in principle]
Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure. Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
ECOG Performance Status of 0-1
Life expectancy ≥ 3 months
Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

History of severe hypersensitivity reactions to other antibodies.
Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
Other exclusion criteria as specified in the study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kanto Region	Kanto	Japan

Sponsors and Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Ohyama Yukiya, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ono Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT00836888

Other Study ID Numbers:

ONO-4538-01

First Posted:

Feb 4, 2009

Last Update Posted:

Oct 8, 2020

Last Verified:

Apr 1, 2015

Keywords provided by Ono Pharmaceutical Co. Ltd

ONO-4538

MDX-1106

solid tumors

Additional relevant MeSH terms:

Neoplasms

Nivolumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
Period Title: Overall Study
STARTED	3	5	6	3
COMPLETED	0	2	0	0
NOT COMPLETED	3	3	6	3

Baseline Characteristics

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts	Total
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour	Total of all reporting groups
Overall Participants	3	5	6	3	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 33.3%	4 80%	5 83.3%	1 33.3%	11 64.7%
>=65 years	2 66.7%	1 20%	1 16.7%	2 66.7%	6 35.3%
Sex: Female, Male (Count of Participants)
Female	1 33.3%	5 100%	0 0%	1 33.3%	7 41.2%
Male	2 66.7%	0 0%	6 100%	2 66.7%	10 58.8%
Performance Status（ECOG） (Count of Participants)
0	1 33.3%	1 20%	2 33.3%	0 0%	4 23.5%
1	2 66.7%	4 80%	4 66.7%	3 100%	13 76.5%
disease stage classification (Count of Participants)
IV	0 0%	3 60%	0 0%	1 33.3%	4 23.5%
IVb	0 0%	0 0%	2 33.3%	0 0%	2 11.8%
Recurrent	3 100%	2 40%	4 66.7%	2 66.7%	11 64.7%
Cancer treatment history (surgery) (Count of Participants)
None	0 0%	1 20%	2 33.3%	2 66.7%	5 29.4%
Present	3 100%	4 80%	4 66.7%	1 33.3%	12 70.6%
Cancer treatment history (radiotherapy) (Count of Participants)
None	3 100%	3 60%	4 66.7%	2 66.7%	12 70.6%
Present	0 0%	2 40%	2 33.3%	1 33.3%	5 29.4%
Cancer treatment history (drug therapy) (Count of Participants)
None	0 0%	0 0%	1 16.7%	0 0%	1 5.9%
Present	3 100%	5 100%	5 83.3%	3 100%	16 94.1%

Outcome Measures

1. Primary Outcome

Title	Cmax at Single Dose
Description
Time Frame	day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
Measure Participants	3	5	6	3
Mean (Standard Deviation) [μg/mL]	24.4 (4.5)	68.8 (10.9)	192 (36)	214 (68)

2. Primary Outcome

Title	AUClast at Single Dose
Description
Time Frame	day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
Measure Participants	3	5	6	3
Mean (Standard Deviation) [μg·h/mL]	4950 (580)	12300 (4500)	43900 (7200)	67400 (15500)

3. Primary Outcome

Title	T1/2 at Single Dose
Description
Time Frame	day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
Measure Participants	3	5	6	3
Mean (Standard Deviation) [day]	15 (0)	13 (7)	21 (11)	17 (9)

4. Primary Outcome

Title	Ceoi at Multiple Doses
Description	Ceoi：Serum concentrations immediately after the end of continuous administration
Time Frame	day 15

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
Measure Participants	3	5	6	3
Mean (Standard Deviation) [μg/mL]	29.3 (6.0)	101 (12)	270 (42)	286 (112)

5. Secondary Outcome

Title	Best Overall Response
Description	Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure. Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.
Time Frame	up to study completion, every 4 weeks in principle

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	ONO-4538 1mg/kg Cohorts	ONO-4538 3mg/kg Cohorts	ONO-4538 10mg/kg Cohorts	ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour	Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
Measure Participants	3	5	6	3
CR	0 0%	1 20%	0 0%	0 0%
PR	1 33.3%	0 0%	1 16.7%	0 0%
SD	0 0%	1 20%	2 33.3%	0 0%
PD	2 66.7%	3 60%	3 50%	3 100%
Unknown	0 0%	0 0%	0 0%	0 0%

Adverse Events

	ONO-4538 1mg/kg Cohorts		ONO-4538 3mg/kg Cohorts		ONO-4538 10mg/kg Cohorts		ONO-4538 20mg/kg Cohorts
Time Frame	All subjects treated with the study drug were followed up for at least 28 days after the last dose.
Adverse Event Reporting Description

Arm/Group Title	ONO-4538 1mg/kg Cohorts		ONO-4538 3mg/kg Cohorts		ONO-4538 10mg/kg Cohorts		ONO-4538 20mg/kg Cohorts
Arm/Group Description	Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour		Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour		Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour		Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Serious Adverse Events
	ONO-4538 1mg/kg Cohorts		ONO-4538 3mg/kg Cohorts		ONO-4538 10mg/kg Cohorts		ONO-4538 20mg/kg Cohorts
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		1/5 (20%)		2/6 (33.3%)		0/3 (0%)
Investigations
alanine aminotransferase increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
aspartate aminotransferase increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
blood bilirubin increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Metabolism and nutrition disorders
dehydration	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
pain in extremity	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant neoplasm progression	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	ONO-4538 1mg/kg Cohorts		ONO-4538 3mg/kg Cohorts		ONO-4538 10mg/kg Cohorts		ONO-4538 20mg/kg Cohorts
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		5/5 (100%)		6/6 (100%)		3/3 (100%)
Cardiac disorders
Atrial fiblillation	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Venticular extrasystoles	0/3 (0%)		1/5 (20%)		2/6 (33.3%)		1/3 (33.3%)
Eye disorders
Vitreous floaters	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Gastrointestinal disorders
Abdominal pain	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Abdominal pain upper	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Cheilitis	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Constipation	1/3 (33.3%)		2/5 (40%)		2/6 (33.3%)		1/3 (33.3%)
Dental caries	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Diarrhoea	1/3 (33.3%)		3/5 (60%)		2/6 (33.3%)		0/3 (0%)
Gastritis	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Nausea	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		2/3 (66.7%)
Stomatitis	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Vomiting	0/3 (0%)		2/5 (40%)		1/6 (16.7%)		1/3 (33.3%)
General disorders
Fatigue	0/3 (0%)		1/5 (20%)		2/6 (33.3%)		1/3 (33.3%)
Malaise	0/3 (0%)		0/5 (0%)		2/6 (33.3%)		1/3 (33.3%)
Pain	0/3 (0%)		2/5 (40%)		0/6 (0%)		0/3 (0%)
Pyrexia	1/3 (33.3%)		1/5 (20%)		2/6 (33.3%)		2/3 (66.7%)
Hepatobiliary disorders
Bile duct stenosis	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Immune system disorders
Hypersensitivity	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Infections and infestations
Cystitis	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Herpes zoster	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Nasopharyngitis	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Pharyngitis	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Skin infection	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Injury, poisoning and procedural complications
Ligament sprain	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Contusion	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Wound	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Tooth fracture	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Investigations
Alanine aminotransferase increased	1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)		1/3 (33.3%)
Ammonia increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Aspartate aminotransferase increased	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		1/3 (33.3%)
Bilirubin conjugated increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Blood albumin decreased	1/3 (33.3%)		3/5 (60%)		2/6 (33.3%)		2/3 (66.7%)
Blood cholesterol increased	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Blood creatine phosphokinase increased	2/3 (66.7%)		0/5 (0%)		2/6 (33.3%)		0/3 (0%)
Blood creatinine increased	0/3 (0%)		0/5 (0%)		2/6 (33.3%)		1/3 (33.3%)
Blood glucose increased	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Blood lactate dehydrogenase increased	1/3 (33.3%)		0/5 (0%)		3/6 (50%)		1/3 (33.3%)
Blood potassium decreased	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Blood potassium increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Blood sodium decreased	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Blood thyroid stimulating hormone decreased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Blood thyroid stimulating hormone increased	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Blood triglycerides increased	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Blood urea increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		1/3 (33.3%)
Blood uric acid increrased	0/3 (0%)		1/5 (20%)		3/6 (50%)		1/3 (33.3%)
C-reactive protein increased	1/3 (33.3%)		2/5 (40%)		2/6 (33.3%)		2/3 (66.7%)
Eosinophil count increased	2/3 (66.7%)		3/5 (60%)		2/6 (33.3%)		1/3 (33.3%)
Gamma-glutamyltransferase increased	1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)		1/3 (33.3%)
Haematocrit decreased	1/3 (33.3%)		3/5 (60%)		2/6 (33.3%)		0/3 (0%)
Haematocrit increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Blood urine preasent	1/3 (33.3%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Haemoglobin decreased	1/3 (33.3%)		3/5 (60%)		2/6 (33.3%)		0/3 (0%)
Haemoglobin increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Lymphocyte count decreased	1/3 (33.3%)		2/5 (40%)		5/6 (83.3%)		2/3 (66.7%)
Neutrophil count decreased	0/3 (0%)		2/5 (40%)		0/6 (0%)		0/3 (0%)
Neutrophil count increased	1/3 (33.3%)		1/5 (20%)		0/6 (0%)		1/3 (33.3%)
Platelet count decreased	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Protein total decreased	1/3 (33.3%)		3/5 (60%)		0/6 (0%)		1/3 (33.3%)
Red blood cell count decreased	1/3 (33.3%)		3/5 (60%)		0/6 (0%)		0/3 (0%)
Red blood cells urine positive	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Weight decreased	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Weight increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
White blood cell count decreased	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
White blood cell count increased	1/3 (33.3%)		1/5 (20%)		1/6 (16.7%)		1/3 (33.3%)
White blood cells urine positive	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Platelet count increased	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Protein urine present	1/3 (33.3%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Tri-iodothyronine free decreased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		1/3 (33.3%)
Thyroxine free decreased	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Rheumatoid factor increased	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Blood alkaline phosphatese increased	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		1/3 (33.3%)
Interleukin level increased	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Antinuclear antibody increased	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Metabolism and nutrition disorders
Dehydration	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Hyperglycaemia	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Hypocalcaemia	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Hyponatraemia	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Decreased appetite	1/3 (33.3%)		0/5 (0%)		3/6 (50%)		2/3 (66.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		2/5 (40%)		0/6 (0%)		0/3 (0%)
Myalgia	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Headache	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Nervous system disorders
Dizziness	0/3 (0%)		1/5 (20%)		0/6 (0%)		2/3 (66.7%)
Hypoaeshesia	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Sensory disturbance	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Somnolence	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Phrenic nerve paralysis	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Psychiatric disorders
Disorientation	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Renal and urinary disorders
Calculus ureteric	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Proteinuria	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Respiratory, thoracic and mediastinal disorders
Cough	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Hypoxia	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Respiratory tract haemorrhage	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Upper respiratory tract inflammation	0/3 (0%)		0/5 (0%)		0/6 (0%)		2/3 (66.7%)
Oropharyngeal pain	0/3 (0%)		1/5 (20%)		1/6 (16.7%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Dematitis acneiform	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)
Erythema	1/3 (33.3%)		2/5 (40%)		1/6 (16.7%)		0/3 (0%)
Palmar-plantar erythodysaethesia syndrome	0/3 (0%)		0/5 (0%)		0/6 (0%)		1/3 (33.3%)
Pruritus	0/3 (0%)		1/5 (20%)		2/6 (33.3%)		0/3 (0%)
Purpura	0/3 (0%)		1/5 (20%)		0/6 (0%)		0/3 (0%)
Rash	1/3 (33.3%)		2/5 (40%)		2/6 (33.3%)		0/3 (0%)
Vascular disorders
Flushing	1/3 (33.3%)		0/5 (0%)		0/6 (0%)		0/3 (0%)
Hypertension	0/3 (0%)		0/5 (0%)		1/6 (16.7%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Ohyama Yukiya
Organization	Ono Pharmaceutical Co. Ltd
Phone
Email	y.ohyama@ono.co.jp

Responsible Party:

Ono Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT00836888

Other Study ID Numbers:

ONO-4538-01

First Posted:

Feb 4, 2009

Last Update Posted:

Oct 8, 2020

Last Verified:

Apr 1, 2015

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact