A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers

• Sponsor: Merrimack Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01447706
• Collaborator: Sanofi (Industry)
• Enrollment: 223
• Locations: 10
• Arms: 2
• Duration (Months): 44
• Patients Per Site: 22.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer	Drug: MM-121; Drug: Paclitaxel	Phase 2

Detailed Description

This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 223 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paclitaxel Standard dosing paclitaxel: 80 mg/m2 QW intravenously)	Drug: Paclitaxel; Standard dosing Paclitaxel (IV)
Experimental: MM-121 (SAR256212) + Paclitaxel administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses	Drug: MM-121; MM-121 (SAR256212) (IV); Other Names: SAR256212 ; Drug: Paclitaxel; Standard dosing Paclitaxel (IV)

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [Time from first dose to date of progression, the longest time frame of 3.9 years]

   To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).

Secondary Outcome Measures

1. Overall Survival [Time from first dose to date of death, with a median of approximately 13 months]

   To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

• Received at least one prior platinum based chemotherapy regimen

• Platinum-resistant or refractory

• Eligible for weekly paclitaxel

• Adequate liver and kidney function

• 18 years of age or above

Exclusion Criteria:

• Evidence of any other active malignancy

• History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Center for Cancer Care	Glendale	Arizona	United States	85306
2	Pinnacle Oncology	Scottsdale	Arizona	United States	85258
3	Comprehensive Blood and Cancer Center	Bakersfield	California	United States	93309
4	Wilshire Oncology Medical Group	Corona	California	United States	92879
5	North County Oncology	Oceanside	California	United States	92056
6	Central Coast Medical Oncology	Santa Maria	California	United States	93454
7	Indiana University Simon Cancer Center	Indianapolis	Indiana	United States	46202
8	Carolinas Medical Center/Blumenthal Cancer Center	Charlotte	North Carolina	United States	28203
9	ProMedica Health System, Inc.	Toledo	Ohio	United States	43606
10	Chattanooga GYN Oncology	Chattanooga	Tennessee	United States	37403

Sponsors and Collaborators

• Merrimack Pharmaceuticals
• Sanofi

Investigators

• Study Director: Victor Moyo, MD, Merrimack Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merrimack Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01447706
• Other Study ID Numbers: MM-121-04-02-08 (ARD11586)
• First Posted: Oct 6, 2011
• Last Update Posted: May 12, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Merrimack Pharmaceuticals: Ovarian Cancer; Platinum-resistant; Platinum-refractory; Fallopian tube cancer; Peritoneal Cancer; Paclitaxel; ErbB3; Phase II; locally advanced/metastatic or recurrent
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Paclitaxel

Study Results

Participant Flow

Arm/Group Title	MM-121 + Paclitaxel	Paclitaxel
Arm/Group Description	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes	Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
Period Title: Overall Study
STARTED	140	83
COMPLETED	140	80
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	MM-121 + Paclitaxel	Paclitaxel	Total
Arm/Group Description	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes	Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes	Total of all reporting groups
Overall Participants	140	83	223
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.5 (10.53)	60.6 (11.85)	59.6 (11.19)
Sex: Female, Male (Count of Participants)
Female	140 100%	83 100%	223 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 7.1%	5 6%	15 6.7%
Not Hispanic or Latino	107 76.4%	62 74.7%	169 75.8%
Unknown or Not Reported	23 16.4%	16 19.3%	39 17.5%
Race/Ethnicity, Customized (participants) [Number]
White/Caucasian	111 79.3%	66 79.5%	177 79.4%
Black or African American	2 1.4%	1 1.2%	3 1.3%
Alaska Native or American Indian	0 0%	0 0%	0 0%
Asian/Oriental	1 0.7%	2 2.4%	3 1.3%
Native Hawaiian or Pacific Islander	0 0%	0 0%	0 0%
Other	18 12.9%	8 9.6%	26 11.7%
Data Not Reported	8 5.7%	6 7.2%	14 6.3%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival
Description	To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Time Frame	Time from first dose to date of progression, the longest time frame of 3.9 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MM-121 + Paclitaxel	Paclitaxel
Arm/Group Description	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes	Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
Measure Participants	140	80
Median (95% Confidence Interval) [months]	3.75	3.68

2. Secondary Outcome

Title	Overall Survival
Description	To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
Time Frame	Time from first dose to date of death, with a median of approximately 13 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MM-121 + Paclitaxel	Paclitaxel
Arm/Group Description	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes	Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
Measure Participants	140	83
Median (95% Confidence Interval) [months]	13.70	10.12

3. Post-Hoc Outcome

Title	To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples
Description	Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients.
Time Frame	Time from first dose to date of progression, the longest time frame of 3.9 years

Outcome Measure Data

Analysis Population Description

Patients with available tissue for RNA-ISH analysis

Arm/Group Title	HRG High: MM-121 + Paclitaxel	HRG High: Paclitaxel	HRG Low: Paclitaxel	HRG Low: MM-121 + Paclitaxel
Arm/Group Description	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes	Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes	Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
Measure Participants	39	19	34	60
Median (95% Confidence Interval) [months PFS]	5.7	3.5	5.4	3.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MM-121 + Paclitaxel, Paclitaxel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	HRG Low: Paclitaxel, HRG Low: MM-121 + Paclitaxel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 1.08 to 2.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	AEs were collected from a patient's first dose until 30 days after treatment termination. SAEs were collected from time of informed consent until 30 days after termination. If related, events could be reported at any time after termination.
Adverse Event Reporting Description	All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for ~1 year after termination.
Arm/Group Title	MM-121 + Paclitaxel		Paclitaxel
Arm/Group Description	MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes		Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
All Cause Mortality
	MM-121 + Paclitaxel		Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MM-121 + Paclitaxel		Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/140 (42.1%)		25/80 (31.3%)
Blood and lymphatic system disorders
Febrile Neutropenia	2/140 (1.4%)		0/80 (0%)
Endocrine disorders
Adrenal Insufficiency	1/140 (0.7%)		0/80 (0%)
Gastrointestinal disorders
Diarrhea	2/140 (1.4%)		0/80 (0%)
Vomiting	1/140 (0.7%)		0/80 (0%)
Abdominal Pain	3/140 (2.1%)		0/80 (0%)
Constipation	1/140 (0.7%)		1/80 (1.3%)
Ascites	3/140 (2.1%)		0/80 (0%)
Intestinal Obstruction	7/140 (5%)		4/80 (5%)
Small Intestinal Obstruction	3/140 (2.1%)		3/80 (3.8%)
Subileus	3/140 (2.1%)		2/80 (2.5%)
Colonic Fistula	1/140 (0.7%)		0/80 (0%)
Enteritis	2/140 (1.4%)		0/80 (0%)
Ileus	1/140 (0.7%)		0/80 (0%)
Abdominal Wall Hematoma	1/140 (0.7%)		0/80 (0%)
Colitis	1/140 (0.7%)		0/80 (0%)
Enterocolitis	1/140 (0.7%)		0/80 (0%)
Gastrointestinal hemorrhage	1/140 (0.7%)		0/80 (0%)
Hemorrhagic ascites	0/140 (0%)		1/80 (1.3%)
General disorders
Fatigue	2/140 (1.4%)		1/80 (1.3%)
Pyrexia	3/140 (2.1%)		4/80 (5%)
Disease Progression	8/140 (5.7%)		1/80 (1.3%)
General Physical Health Deterioration	2/140 (1.4%)		1/80 (1.3%)
Infusion Site Extravasion	0/140 (0%)		1/80 (1.3%)
Hepatobiliary disorders
Hepatotoxicity	0/140 (0%)		1/80 (1.3%)
Infections and infestations
Urinary Tract Infection	2/140 (1.4%)		0/80 (0%)
Device related infection	2/140 (1.4%)		0/80 (0%)
Gastroenteritis	0/140 (0%)		1/80 (1.3%)
Pneumonia	1/140 (0.7%)		1/80 (1.3%)
Escherichia Sepsis	1/140 (0.7%)		0/80 (0%)
Pyelonephritis	1/140 (0.7%)		0/80 (0%)
Abdominal Abscess	1/140 (0.7%)		0/80 (0%)
Infection	1/140 (0.7%)		0/80 (0%)
Pelvic Abscess	1/140 (0.7%)		0/80 (0%)
Urosepsis	1/140 (0.7%)		0/80 (0%)
Bacteremia	0/140 (0%)		1/80 (1.3%)
Gastroenteritis viral	0/140 (0%)		1/80 (1.3%)
Injury, poisoning and procedural complications
Foot fracture	1/140 (0.7%)		0/80 (0%)
Hip fracture	1/140 (0.7%)		0/80 (0%)
Post-procedural Fistula	1/140 (0.7%)		0/80 (0%)
Investigations
Ejection Fraction Decreased	1/140 (0.7%)		0/80 (0%)
International Normalized Ratio Increased	1/140 (0.7%)		0/80 (0%)
Metabolism and nutrition disorders
Hypomagnesemia	1/140 (0.7%)		0/80 (0%)
Hypocalcemia	2/140 (1.4%)		0/80 (0%)
Hypophosphatemia	1/140 (0.7%)		0/80 (0%)
Musculoskeletal and connective tissue disorders
Back Pain	2/140 (1.4%)		0/80 (0%)
Systemic Lupus Erythematosus	1/140 (0.7%)		0/80 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer	1/140 (0.7%)		0/80 (0%)
Neoplasm malignant	1/140 (0.7%)		1/80 (1.3%)
Psychiatric disorders
Depression	1/140 (0.7%)		0/80 (0%)
Mental Status Change	1/140 (0.7%)		0/80 (0%)
Renal and urinary disorders
Hydronephrosis	1/140 (0.7%)		1/80 (1.3%)
Renal Pain	0/140 (0%)		1/80 (1.3%)
Urinary Fistula	1/140 (0.7%)		0/80 (0%)
Reproductive system and breast disorders
Female Genital Tract Fistula	0/140 (0%)		1/80 (1.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	3/140 (2.1%)		1/80 (1.3%)
Pulmonary Embolism	3/140 (2.1%)		0/80 (0%)
Pleural Effusion	0/140 (0%)		2/80 (2.5%)
Pneumonitis	1/140 (0.7%)		0/80 (0%)
Lung Disorder	1/140 (0.7%)		0/80 (0%)
Respiratory Distress	1/140 (0.7%)		0/80 (0%)
Skin and subcutaneous tissue disorders
Onycholysis	1/140 (0.7%)		0/80 (0%)
Hyperkeratosis	1/140 (0.7%)		0/80 (0%)
Toxic Skin eruption	1/140 (0.7%)		0/80 (0%)
Vascular disorders
Embolism	1/140 (0.7%)		0/80 (0%)
Phlebitis	0/140 (0%)		1/80 (1.3%)
Pelvic Venous Thrombosis	0/140 (0%)		1/80 (1.3%)
Other (Not Including Serious) Adverse Events
	MM-121 + Paclitaxel		Paclitaxel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	140/140 (100%)		79/80 (98.8%)
Blood and lymphatic system disorders
Anemia	39/140 (27.9%)		24/80 (30%)
Neutropenia	22/140 (15.7%)		17/80 (21.3%)
Leukopenia	7/140 (5%)		5/80 (6.3%)
Neutrophil Count Decreased	7/140 (5%)		6/80 (7.5%)
Cardiac disorders
Tachycardia	7/140 (5%)		3/80 (3.8%)
Eye disorders
Vision Blurred	8/140 (5.7%)		1/80 (1.3%)
Lacrimation Increased	7/140 (5%)		2/80 (2.5%)
Gastrointestinal disorders
Diarrhea	103/140 (73.6%)		34/80 (42.5%)
Nausea	60/140 (42.9%)		39/80 (48.8%)
Vomiting	44/140 (31.4%)		15/80 (18.8%)
Abdominal pain	41/140 (29.3%)		20/80 (25%)
Stomatits	31/140 (22.1%)		8/80 (10%)
Constipation	26/140 (18.6%)		21/80 (26.3%)
Dyspepsia	19/140 (13.6%)		6/80 (7.5%)
Abdominal Distension	13/140 (9.3%)		8/80 (10%)
Abdominal Pain Upper	13/140 (9.3%)		9/80 (11.3%)
Ascites	9/140 (6.4%)		7/80 (8.8%)
Dry Mouth	9/140 (6.4%)		1/80 (1.3%)
Hemorrhoids	8/140 (5.7%)		0/80 (0%)
Intestinal Obstruction	8/140 (5.7%)		4/80 (5%)
General disorders
Fatigue	63/140 (45%)		30/80 (37.5%)
Asthenia	34/140 (24.3%)		17/80 (21.3%)
Peripheral Edema	33/140 (23.6%)		16/80 (20%)
Mucosal Inflammation	31/140 (22.1%)		1/80 (1.3%)
Pyrexia	25/140 (17.9%)		21/80 (26.3%)
Chills	8/140 (5.7%)		4/80 (5%)
Disease Progression	8/140 (5.7%)		1/80 (1.3%)
Influenza-like illness	8/140 (5.7%)		3/80 (3.8%)
Pain	8/140 (5.7%)		7/80 (8.8%)
Infections and infestations
Urinary Tract Infection	19/140 (13.6%)		12/80 (15%)
Nasopharyngitis	13/140 (9.3%)		7/80 (8.8%)
Rhinitis	11/140 (7.9%)		1/80 (1.3%)
Injury, poisoning and procedural complications
Fall	7/140 (5%)		0/80 (0%)
Investigations
Weight Decreased	11/140 (7.9%)		2/80 (2.5%)
Metabolism and nutrition disorders
Decreased appetite	35/140 (25%)		20/80 (25%)
Hypokalemia	34/140 (24.3%)		7/80 (8.8%)
Hypomagnesemia	31/140 (22.1%)		12/80 (15%)
Hyperglycemia	15/140 (10.7%)		6/80 (7.5%)
Dehydration	14/140 (10%)		3/80 (3.8%)
Musculoskeletal and connective tissue disorders
Myalgia	23/140 (16.4%)		7/80 (8.8%)
Muscle Spasms	18/140 (12.9%)		6/80 (7.5%)
Back Pain	14/140 (10%)		12/80 (15%)
Arthralgia	13/140 (9.3%)		12/80 (15%)
Pain in Extremity	7/140 (5%)		9/80 (11.3%)
Nervous system disorders
Peripheral neuropathy	26/140 (18.6%)		20/80 (25%)
Dizziness	22/140 (15.7%)		4/80 (5%)
Peripheral Sensory Neuropathy	19/140 (13.6%)		5/80 (6.3%)
Dysgeusia	18/140 (12.9%)		16/80 (20%)
Headache	18/140 (12.9%)		13/80 (16.3%)
Parasthesia	17/140 (12.1%)		8/80 (10%)
Neurotoxicity	11/140 (7.9%)		5/80 (6.3%)
Psychiatric disorders
Anxiety	16/140 (11.4%)		6/80 (7.5%)
Insomnia	11/140 (7.9%)		7/80 (8.8%)
Depression	9/140 (6.4%)		5/80 (6.3%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	33/140 (23.6%)		14/80 (17.5%)
Cough	25/140 (17.9%)		18/80 (22.5%)
Dyspnea	24/140 (17.1%)		12/80 (15%)
Dysphonia	15/140 (10.7%)		3/80 (3.8%)
Oropharyngeal Pain	8/140 (5.7%)		3/80 (3.8%)
Skin and subcutaneous tissue disorders
Alopecia	53/140 (37.9%)		26/80 (32.5%)
Rash	34/140 (24.3%)		10/80 (12.5%)
Erythema	18/140 (12.9%)		2/80 (2.5%)
Dry Skin	13/140 (9.3%)		2/80 (2.5%)
Pruritis	13/140 (9.3%)		9/80 (11.3%)
Onycholysis	12/140 (8.6%)		4/80 (5%)
Palmer-Plantar Erythrodysasthesia Syndrome	8/140 (5.7%)		0/80 (0%)
Nail toxicity	7/140 (5%)		1/80 (1.3%)
Rash Maculo-papular	7/140 (5%)		1/80 (1.3%)
Vascular disorders
Flushing	12/140 (8.6%)		7/80 (8.8%)
Hypertension	11/140 (7.9%)		2/80 (2.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.