Investigate the safety and tolerability of olaparib tablet in Japanese patients with advanced solid malignancies

Study identifier:D081BC00001

ClinicalTrials.gov identifier:NCT01813474

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, open-label study to assess the safety and tolerability of doses of olaparib tablet in Japanese patients with advanced solid malignancies

Medical condition

cancer

Phase

Phase 1

Healthy volunteers

Study drug

olaparib

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 130 Years

Date

Study Start Date: 25 Mar 2013

Primary Completion Date: 31 Aug 2016

Study Completion Date: 31 Aug 2016

Study design

Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2017 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Sapporo-shi, Japan, 003-0804

Location

Research Site

Chuo-ku, Japan, 104-0045

Location

Research Site

Fukuoka-shi, Japan, 811-1395

Arms	Assigned Interventions
Experimental: olaparib tablet monotherapy olaparib tablet	Drug: olaparib tablet oral

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled on 25 March 2013. Last patient enrolled on 31 October 2013. Data cut off on 31 July 2014.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 28 participants gave informed consent to join this study. Five participants were screen failures so that 23 participants were assigned and received study treatment

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg bid, expansion part	Olaparib tablet 300 mg bid, 600 mg/day, expansion part

Participant Flow: Overall Study

	200 mg bid, dose escalation part	300 mg bid, dose escalation part	300 mg bid, expansion part
STARTED	4	7	12
COMPLETED	1^[1]	0	1^[2]
NOT COMPLETED	3	7	11
Withdrawal by Subject	0	0	1
Adverse Event	1	1	0
Lack of Efficacy	2	6	9
Death	0	0	1

[1]	ongoing study at final data cut off
[2]	ongoing study at final data cut off

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg bid, expansion part	Olaparib tablet 300 mg bid, 600 mg/day, expansion part

Baseline Measures

	200 mg bid, dose escalation part	300 mg bid, dose escalation part	300 mg bid, expansion part	Total
Number of Participants [units: Participants]	4	7	12	23
Age Continuous [units: Years] Mean ± Standard Deviation	42.0 ± 8.68	55.4 ± 8.98	57.3 ± 12.43	54.1 ± 11.94
Sex: Female, Male [units: ] Sex
Female	4	4	7	15
Male	0	3	5	8
Primary tumour location [units: Participants]
Breast	1	1	3	5
Colorectal	0	0	1	1
Lung	0	1	2	3
Peritoneum	0	0	1	1
Pancreas	0	1	0	1
Ovary	0	2	2	4
Uterus	1	1	0	2
Cervix	2	0	0	2
Colon	0	0	1	1
Gastric Antrum	0	0	1	1
Other	0	1	1	2

Outcome Measures

1. Primary Outcome Measure: Number of Participants With Adverse Events [ Time Frame: From the start dose to 30 days after the last dose of study drug ]

Measure Type	Primary
Measure Name	Number of Participants With Adverse Events
Measure Description	An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.
Time Frame	From the start dose to 30 days after the last dose of study drug
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg bid, expansion part	Olaparib tablet 300 mg bid, 600 mg/day, expansion part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part	300 mg bid, expansion part
Number of Participants Analyzed [units:participants]	4	7	12
Number of Participants With Adverse Events [units: Participants]
Overall Number of Participants Analyzed	4	7	12
At least 1 Adverse Events (AE)	4	7	10
At least 1 AE of CTCAE Grade 3 or higher	1	3	1
At least 1 Serious Adverse Events (SAE)	1	0	0

No statistical analysis provided for Number of Participants With Adverse Events

2. Secondary Outcome Measure: Number of Participants With Dose Limiting Toxicities [ Time Frame: From the start dose to 28 days after the first dose of study drug ]

Measure Type	Secondary
Measure Name	Number of Participants With Dose Limiting Toxicities
Measure Description	Dose Limiting Toxicities were defined as study specific events that is determined to be possibly or probably related to olaparib (as determined by the investigator) and occurring during the first cycle of treatment (28 days after the first dose), irrespective of whether the toxicity resolved.
Time Frame	From the start dose to 28 days after the first dose of study drug
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients in only the dose escalation part who received olaparib and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib tablet 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	3	6
Number of Participants With Dose Limiting Toxicities [units: Participants]	0	0

No statistical analysis provided for Number of Participants With Dose Limiting Toxicities

3. Secondary Outcome Measure: Cmax following single dosing [ Time Frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose ]

Measure Type	Secondary
Measure Name	Cmax following single dosing
Measure Description
Time Frame	Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose escalation part only

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	4	7
Cmax following single dosing [units: μg/mL] Geometric Mean (Geometric Coefficient of Variation)	6.697 (95.69%)	7.743 (34.76%)

No statistical analysis provided for Cmax following single dosing

4. Secondary Outcome Measure: Cmax following multiple dosing [ Time Frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose ]

Measure Type	Secondary
Measure Name	Cmax following multiple dosing
Measure Description
Time Frame	Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	3	6
Cmax following multiple dosing [units: μg/mL] Geometric Mean (Geometric Coefficient of Variation)	7.668 (46.93%)	8.434 (35.05%)

No statistical analysis provided for Cmax following multiple dosing

5. Secondary Outcome Measure: tmax following single dosing [ Time Frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose ]

Measure Type	Secondary
Measure Name	tmax following single dosing
Measure Description
Time Frame	Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose escalation part only

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	4	7
tmax following single dosing [units: hour] Median (Full Range)	2.00 (1.00 to 3.00)	1.98 (1.00 to 3.00)

No statistical analysis provided for tmax following single dosing

6. Secondary Outcome Measure: tmax following multiple dosing [ Time Frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose ]

Measure Type	Secondary
Measure Name	tmax following multiple dosing
Measure Description
Time Frame	Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	3	6
tmax following multiple dosing [units: hour] Median (Full Range)	1.50 (1.00 to 3.00)	3.00 (1.50 to 3.93)

No statistical analysis provided for tmax following multiple dosing

7. Secondary Outcome Measure: AUC following single dosing [ Time Frame: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose ]

Measure Type	Secondary
Measure Name	AUC following single dosing
Measure Description
Time Frame	Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose escalation part only. One participant in 200 mg bid had no AUC data because AUC was not calculable for this participant.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	3	7
AUC following single dosing [units: μg*h/mL] Geometric Mean (Geometric Coefficient of Variation)	61.97 (473.4%)	46.21 (64.64%)

No statistical analysis provided for AUC following single dosing

8. Secondary Outcome Measure: AUC at steady state following multiple dosing [ Time Frame: Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose ]

Measure Type	Secondary
Measure Name	AUC at steady state following multiple dosing
Measure Description
Time Frame	Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose
Safety Issue?

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part

Measured Values

	200 mg bid, dose escalation part	300 mg bid, dose escalation part
Number of Participants Analyzed [units:participants]	3	6
AUC at steady state following multiple dosing [units: μg*h/mL] Geometric Mean (Geometric Coefficient of Variation)	36.50 (71.94%)	52.34 (68.17%)

No statistical analysis provided for AUC at steady state following multiple dosing

Serious Adverse Events

Time Frame	Through treatment and 30-day follow-up period, an average of about 4 months.
Additional Description	No text entered.

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg bid, expansion part	Olaparib tablet 300 mg bid, 600 mg/day, expansion part

Serious Adverse Events

200 mg bid, dose escalation part

300 mg bid, dose escalation part

300 mg bid, expansion part

Total, serious adverse events

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

0/12 (0.00%)

Gastrointestinal disorders

Ileus¹

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

0/12 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA Version 16.0

Other Adverse Events

Time Frame	Through treatment and 30-day follow-up period, an average of about 4 months.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
200 mg bid, dose escalation part	Olaparib tablet 200 mg bid, 400 mg/day, dose escalation part
300 mg bid, dose escalation part	Olaparib table 300 mg bid, 600 mg/day, dose escalation part
300 mg bid, expansion part	Olaparib tablet 300 mg bid, 600 mg/day, expansion part

Other Adverse Events

200 mg bid, dose escalation part

300 mg bid, dose escalation part

300 mg bid, expansion part

Total, other (not including serious) adverse events

# participants affected / at risk

4/4 (100.00%)

7/7 (100.00%)

10/12 (83.33%)

Infections and infestations

Nasopharyngitis¹

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

1/12 (8.33%)

Infections and infestations

Paronychia¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Infections and infestations

Pneumonia¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Infections and infestations

Pyelonephritis¹

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

0/12 (0.00%)

Infections and infestations

Upper respiratory tract infection¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Blood and lymphatic system disorders

Anaemia¹

# participants affected / at risk

0/4 (0.00%)

4/7 (57.14%)

2/12 (16.67%)

Blood and lymphatic system disorders

Neutropenia¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Metabolism and nutrition disorders

Decreased appetite¹

# participants affected / at risk

0/4 (0.00%)

4/7 (57.14%)

3/12 (25.00%)

Metabolism and nutrition disorders

Hypoglycaemia¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Psychiatric disorders

Anxiety¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Nervous system disorders

Dizziness¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Nervous system disorders

Dysgeusia¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Nervous system disorders

Headache¹

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

0/12 (0.00%)

Eye disorders

Erythema of eyelid¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Eye disorders

Eye pruritus¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Respiratory, thoracic and mediastinal disorders

Cough¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Respiratory, thoracic and mediastinal disorders

Dysaesthesia pharynx¹

# participants affected / at risk

1/4 (25.00%)

1/7 (14.29%)

0/12 (0.00%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Gastrointestinal disorders

Abdominal pain upper¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

1/12 (8.33%)

Gastrointestinal disorders

Constipation¹

# participants affected / at risk

0/4 (0.00%)

2/7 (28.57%)

4/12 (33.33%)

Gastrointestinal disorders

Diarrhoea¹

# participants affected / at risk

0/4 (0.00%)

2/7 (28.57%)

2/12 (16.67%)

Gastrointestinal disorders

Duodenitis¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Gastrointestinal disorders

Dyspepsia¹

# participants affected / at risk

0/4 (0.00%)

2/7 (28.57%)

1/12 (8.33%)

Gastrointestinal disorders

Gastritis¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Gastrointestinal disorders

Nausea¹

# participants affected / at risk

1/4 (25.00%)

6/7 (85.71%)

3/12 (25.00%)

Gastrointestinal disorders

Stomatitis¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Gastrointestinal disorders

Toothache¹

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

0/12 (0.00%)

Gastrointestinal disorders

Vomiting¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

1/12 (8.33%)

Hepatobiliary disorders

Hepatic function abnormal¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Skin and subcutaneous tissue disorders

Palmar-plantar erythrodysaesthesia syndrome¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Skin and subcutaneous tissue disorders

Pruritus¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Skin and subcutaneous tissue disorders

Rash maculo-papular¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Musculoskeletal and connective tissue disorders

Arthralgia¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Musculoskeletal and connective tissue disorders

Back pain¹

# participants affected / at risk

1/4 (25.00%)

0/7 (0.00%)

0/12 (0.00%)

Musculoskeletal and connective tissue disorders

Myalgia¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Musculoskeletal and connective tissue disorders

Pain in extremity¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Renal and urinary disorders

Proteinuria¹

# participants affected / at risk

0/4 (0.00%)

2/7 (28.57%)

0/12 (0.00%)

General disorders

Fatigue¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

2/12 (16.67%)

General disorders

Malaise¹

# participants affected / at risk

0/4 (0.00%)

2/7 (28.57%)

2/12 (16.67%)

General disorders

Oedema¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

General disorders

Pyrexia¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Investigations

Alanine aminotransferase increased¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

1/12 (8.33%)

Investigations

Aspartate aminotransferase increased¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

1/12 (8.33%)

Investigations

Blood creatinine increased¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

1/12 (8.33%)

Investigations

Grip strength decreased¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Investigations

Lymphocyte count decreased¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Investigations

Neutrophil count decreased¹

# participants affected / at risk

0/4 (0.00%)

2/7 (28.57%)

2/12 (16.67%)

Investigations

Platelet count decreased¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

Investigations

White blood cell count decreased¹

# participants affected / at risk

0/4 (0.00%)

3/7 (42.86%)

2/12 (16.67%)

Injury, poisoning and procedural complications

Contusion¹

# participants affected / at risk

0/4 (0.00%)

0/7 (0.00%)

1/12 (8.33%)

Injury, poisoning and procedural complications

Procedural pain¹

# participants affected / at risk

0/4 (0.00%)

1/7 (14.29%)

0/12 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA Version 16.0

Certain Agreements

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

There is NOT 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Medical Director
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

D081BC00001_Study_Report_Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Thomas Morris

Global Medicines Development

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

D081BC00001_Study_Report_Synopsis

Trial Results Summaries