Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02736617
• Collaborator: Genentech, Inc. (Industry), Oregon Health and Science University (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 58.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This phase II trial studies how well obinutuzumab works in combination with ibrutinib in treating patients with mantle cell lymphoma that has returned (relapsed) or that does not respond to treatment (refractory). Obinutuzumab binds to a protein called cluster of differentiation (CD)20, which is found on B cells and some types of leukemia and lymphoma cells and help the immune system kill cancer cells. Ibrutinib blocks a protein called Bruton's tyrosine kinase (BTK), which may help keep cancer cells from growing. Giving obinutuzumab in combination with ibrutinib may kill more cancer cells.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma	Drug: Ibrutinib; Biological: Obinutuzumab	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. Best overall response of complete response/partial response (CR/PR).

SECONDARY OBJECTIVES:

1. Toxicity defined as any adverse event (AE) grade 3 and higher. II. Progression free survival.

EXPLORATORY/CORRELATIVE OBJECTIVES:

1. Gene expression profiling using Lymph5Cx test. II. Sequencing using the ion torrent platform (76 gene panel for known mutations in lymphoma).

2. Sequencing of BTK and phospholipase-C gamma (PLC) to evaluate for mutations.

3. Minimal residual disease testing (MRD by flow cytometry and targeted sequencing post treatment).

OUTLINE:

Patients receive obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving partial response (PR) continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Obinutuzumab (GA-101) in Combination With Ibrutinib (I) for the Treatment of Relapsed Mantle Cell Lymphoma
• Actual Study Start Date: Jul 5, 2016
• Actual Primary Completion Date: Jun 2, 2021
• Actual Study Completion Date: Jun 2, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (obinutuzumab and ibrutinib) Patients receive obinutuzumab IV over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have PR continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.

Drug: Ibrutinib; Given PO; Other Names: BTK Inhibitor PCI-32765 CRA-032765 Imbruvica PCI-32765 ; Biological: Obinutuzumab; Given IV; Other Names: Anti-CD20 Monoclonal Antibody R7159 GA-101 GA101 Gazyva huMAB(CD20) R7159 RO 5072759 RO-5072759 RO5072759

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With Best Overall Objective Response or Complete Response/Partial Response (CR/PR) [From first dose of study therapy until the 6-month disease assessment (Cycle 6, Day1 or End of Induction Day 28). Disease assessment is also assessed at end of Cycle 2 (2-months).]

   Overall response is measured combining bone marrow biopsy with CT or PET, measuring target and evaluable non-targeted lesions, according to the Lugano criteria. For FDG-PET, the Deauville criteria is used in conjecture with CT to assess lesion FDG-update. Deauville scale ranges from 1 to 5, where 1 is best (no uptake or no residual uptake) and 5 is worst (markedly increased uptake or any new lesion). If bone marrow is involved prior to treatment, infiltrate must have cleared on repeat biopsy for CR; bone marrow assessment is irrelevant for determination of PR. Measurements are taken at baseline, end of cycle 2, end of induction (after cycle 6) and every 4 months thereafter. Best overall response is any CR or PR reported since start of therapy. Percent of participants with complete response or partial response (CR+PR) are reported along with 95% confidence interval.

Secondary Outcome Measures

1. Progression Free Survival (PFS) [Time from the first day of combined study treatment to disease progression or death, whichever occurs first, assessed up to approximately 4 years, 11 months, after first dose of study drug(s)]

   Median progression free survival is measured from first day of study therapy until disease progression or death, whichever comes first. Participants who progress prior to their first scheduled disease assessment are considered to have clinically progressed. Participants who do not progress are censored at the time of their last disease assessment. The Kaplan-Meier method is used to estimate median PFS. 95% confidence interval is provided, although upper limit was not achieved (insufficient number of progressions)

2. Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 [Measured from the first dose of either study drug until 30 days after the last dose of study drug, for approximately 4 years, 11 months.]

   Defined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, from the first dose of study drug(s) until 30 days after the last dose of study drug(s)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects must have a diagnosis of relapsed or refractory mantle cell lymphoma as follows:

• Diagnosis of mantle cell lymphoma (MCL) must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)

• Relapsed or refractory disease is defined as no response or progressive disease to prior treatment if the prior treatment comprised any of the following:

• 1 regimen containing an anti-CD20 antibody administered for >= 2 doses, and/or

• = 1 regimen containing 1 cytotoxic agent (e.g., bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin) administered for 2 cycles

• At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma (Cheson Criteria); the site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

• Absolute neutrophil count (ANC) >= 1.0 K/cu mm; for subjects with ANC < 1.0 K/cu mm due to significant marrow involvement by MCL, ANC must be > .5 K/cu mm

• Platelets (plt) >= 50 K/cu mm; for subjects with plt < 50 K/cu mm due to significant marrow involvement by MCL, plt must be > 25 K/cu mm

• Total bilirubin =< 2.5 X institutional limits

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal

• Creatinine =< 2

• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 18 months after last dose of obinutuzumab, or 1 month after the last dose of ibrutinib, whichever is later; for males, these restrictions apply for 180 days after the last dose of obinutuzumab or 3 months after the last dose of ibrutinib, whichever is later

• Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Major surgery within 4 weeks of drug administration

• Diagnosed or treated for malignancy other than MCL, except:

• Malignancy treated with curative intent and with no known active disease present for >= 2 years

• Adequately treated non-melanoma skin cancer or melanoma in situ without evidence of disease

• Adequately treated cervical carcinoma in situ without evidence of disease

• Asymptomatic prostate cancer managed with "active surveillance"

• Localized prostate cancer treated with definitive treatment including radiation or surgery. Patients on adjuvant hormone deprivation treatment such as lupron are eligible. Patients with known metastatic disease are ineligible

• History of stroke or intracranial hemorrhage within 6 months prior to randomization

• Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)

• Vaccinated with live, attenuated vaccines within 4 weeks of randomization

• Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors

• Subjects who have had standard cytotoxic chemotherapy or radiotherapy within 3 weeks prior to entering the study or those whose adverse events due to agents administered more than 3 weeks earlier have not recovered to =< grade 1; this excludes alopecia and hematologic adverse events

• Subjects who have had radiotherapy within 2 weeks prior to entering the study or those whose adverse events due to radiotherapy more than 2 weeks earlier have not recovered to =< grade 1

• Subjects who have received investigational or approved oral or "targeted" agents (such as spleen tyrosine kinase [SYK], phosphatidylinositol 3 kinase [PI3K], B-cell chronic lymphocytic leukemia [CLL]/lymphoma 2 [bcl-2], BTK inhibitors) or lenalidomide within 1 week prior to entering the study or those whose adverse events due to agents administered more than 1 week earlier have not recovered to =< grade 1; this excludes hematologic adverse events; the exception is subjects who are currently receiving ibrutinib (for < 14 days). In this case, ibrutinib can be continued

• Subjects who have received monoclonal antibodies (such as Rituxan) within 1 week prior to entering the study or those whose adverse events due to agents administered more than 1 week earlier have not recovered to =< grade 1; this excludes hematologic adverse events

• Subjects who are actively receiving any other investigational agents

• History of severe allergic reactions attributed to compounds of similar chemical or biologic composition as obinutuzumab or ibrutinib or other agents used in the study

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or lactating women are excluded from this study

• Known history of human immunodeficiency virus (HIV) or active hepatitis C

• Virus or active hepatitis B virus infection; patients who are hepatitis B core antibody (HBcAb) positive may be eligible as long as there is no evidence of active infection with negative hepatitis B (Hep B) by polymerase chain reaction (PCR); in this case, Hep B PCR must be monitored monthly

• Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics

• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk

• Patients previously treated with ibrutinib > 14 days are ineligible; no drug intervention or cessation is required for patients already receiving ibrutinib prior to initiation of on-study therapy

• Active graft versus (vs.) host disease (GVHD)

• Ongoing glucocorticoids (prednisone > 10 mg daily, or equivalent); higher doses (> 10 mg daily) are permitted for up to 5 days to help control disease related symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• Genentech, Inc.
• Oregon Health and Science University

Investigators

• Principal Investigator: Stephen E Spurgeon, OHSU Knight Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 4, 2020

More Information

Publications

None provided.

• Responsible Party: Stephen Spurgeon, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT02736617
• Other Study ID Numbers: STUDY00015255; NCI-2016-00398; STUDY00015255
• First Posted: Apr 13, 2016
• Last Update Posted: Jan 5, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Mantle-Cell; Obinutuzumab

Study Results

Participant Flow

Arm/Group Title	Overall Study
Arm/Group Description	Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
Period Title: Treatment
STARTED	10
COMPLETED	7
NOT COMPLETED	3
Period Title: Treatment
STARTED	7
COMPLETED	2
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Participants who receive at least one dose of either study drug.
Overall Participants	10
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	72.0
Sex: Female, Male (Count of Participants)
Female	1 10%
Male	9 90%
Race/Ethnicity, Customized (Count of Participants)
White, non-Hispanic	10 100%
Disease status at enrollment (Count of Participants)
Stable Disease	5 50%
Progressive Disease	5 50%
Mantle Cell Lymphoma International Prognositic Index (MIPI) Risk Class (Count of Participants)
Intermediate Risk	3 30%
High Risk	7 70%
Ki-67 positivity, % (proliferation marker) (percent positive nuclei in field) [Median (Full Range) ]
Median (Full Range) [percent positive nuclei in field]	65
Eastern Cooperative Oncology Group (ECOG) at screening (Count of Participants)
ECOG 0	1 10%
ECOG 1	9 90%
Months between diagnosis and enrollment (Months) [Median (Full Range) ]
Median (Full Range) [Months]	21.5

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With Best Overall Objective Response or Complete Response/Partial Response (CR/PR)
Description	Overall response is measured combining bone marrow biopsy with CT or PET, measuring target and evaluable non-targeted lesions, according to the Lugano criteria. For FDG-PET, the Deauville criteria is used in conjecture with CT to assess lesion FDG-update. Deauville scale ranges from 1 to 5, where 1 is best (no uptake or no residual uptake) and 5 is worst (markedly increased uptake or any new lesion). If bone marrow is involved prior to treatment, infiltrate must have cleared on repeat biopsy for CR; bone marrow assessment is irrelevant for determination of PR. Measurements are taken at baseline, end of cycle 2, end of induction (after cycle 6) and every 4 months thereafter. Best overall response is any CR or PR reported since start of therapy. Percent of participants with complete response or partial response (CR+PR) are reported along with 95% confidence interval.
Time Frame	From first dose of study therapy until the 6-month disease assessment (Cycle 6, Day1 or End of Induction Day 28). Disease assessment is also assessed at end of Cycle 2 (2-months).

Outcome Measure Data

Analysis Population Description

Efficacy evaluable population: those who receive at least one dose of both study drugs and had one response assessment (after cycle 2). Any patient who clinically progresses prior to their first scheduled response assessment will be included in the efficacy set and will be counted as a non-responder.

Arm/Group Title	Efficacy Evaluable
Arm/Group Description	Participants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
Measure Participants	9
Number (95% Confidence Interval) [percentage of participants]	89 890%

2. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	Median progression free survival is measured from first day of study therapy until disease progression or death, whichever comes first. Participants who progress prior to their first scheduled disease assessment are considered to have clinically progressed. Participants who do not progress are censored at the time of their last disease assessment. The Kaplan-Meier method is used to estimate median PFS. 95% confidence interval is provided, although upper limit was not achieved (insufficient number of progressions)
Time Frame	Time from the first day of combined study treatment to disease progression or death, whichever occurs first, assessed up to approximately 4 years, 11 months, after first dose of study drug(s)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Efficacy Evaluable
Arm/Group Description	Participants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
Measure Participants	9
Median (95% Confidence Interval) [months]	14

3. Secondary Outcome

Title	Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0
Description	Defined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, from the first dose of study drug(s) until 30 days after the last dose of study drug(s)
Time Frame	Measured from the first dose of either study drug until 30 days after the last dose of study drug, for approximately 4 years, 11 months.

Outcome Measure Data

Analysis Population Description

All participants receiving at least 1 dose of IV Obinutuzumab or oral Ibrutinib

Arm/Group Title	Overall Study
Arm/Group Description	Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
Measure Participants	10
Infections and infestations	1 10%
Infusion related reaction	1 10%
Neutrophil count decreased	4 40%
Platelet count decreased	2 20%
Stroke	1 10%

Adverse Events

Time Frame	From the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months)
Adverse Event Reporting Description	All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
Arm/Group Title	Overall Study
Arm/Group Description	Participants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
All Cause Mortality
	Overall Study
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	4/10 (40%)
Infections and infestations
Infections and infestations - Other, specify	2/10 (20%)	2
Injury, poisoning and procedural complications
Infusion related reaction	1/10 (10%)	1
Musculoskeletal and connective tissue disorders
Pain in extremity	1/10 (10%)	1
Nervous system disorders
Somnolence	1/10 (10%)	1
Stroke	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
Cardiac disorders
Atrial fibrillation	1/10 (10%)	1
Cardiac disorders - Other, specify	2/10 (20%)	3
Palpitations	1/10 (10%)	1
Supraventricular tachycardia	1/10 (10%)	1
Ear and labyrinth disorders
Hearing impaired	1/10 (10%)	1
Eye disorders
Eye disorders - Other, specify	2/10 (20%)	3
Gastrointestinal disorders
Diarrhea	3/10 (30%)	3
Gastritis	1/10 (10%)	1
Gastrointestinal disorders - Other, specify	3/10 (30%)	6
Hemorrhoids	1/10 (10%)	1
Nausea	4/10 (40%)	4
Oral hemorrhage	1/10 (10%)	1
Vomiting	1/10 (10%)	1
General disorders
Edema limbs	1/10 (10%)	1
Fatigue	3/10 (30%)	7
Fever	1/10 (10%)	1
Pain	2/10 (20%)	2
Infections and infestations
Infections and infestations - Other, specify	1/10 (10%)	1
Otitis media	1/10 (10%)	1
Sinusitis	2/10 (20%)	5
Tooth infection	1/10 (10%)	1
Upper respiratory infection	4/10 (40%)	4
Wound infection	1/10 (10%)	1
Injury, poisoning and procedural complications
Bruising	4/10 (40%)	5
Fall	1/10 (10%)	1
Infusion related reaction	3/10 (30%)	3
Injury, poisoning and procedural complications - Other, specify	1/10 (10%)	1
Wound dehiscence	1/10 (10%)	1
Investigations
Blood bilirubin increased	2/10 (20%)	2
Neutrophil count decreased	4/10 (40%)	15
Platelet count decreased	4/10 (40%)	8
Weight gain	1/10 (10%)	1
Weight loss	1/10 (10%)	1
Metabolism and nutrition disorders
Anorexia	3/10 (30%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	3/10 (30%)	5
Bone pain	3/10 (30%)	3
Chest wall pain	1/10 (10%)	1
Generalized muscle weakness	1/10 (10%)	2
Musculoskeletal and connective tissue disorder - Other, specify	1/10 (10%)	2
Myalgia	2/10 (20%)	2
Pain in extremity	3/10 (30%)	4
Nervous system disorders
Dizziness	1/10 (10%)	2
Headache	1/10 (10%)	1
Nervous system disorders - Other, specify	4/10 (40%)	7
Neuralgia	1/10 (10%)	1
Psychiatric disorders
Anxiety	1/10 (10%)	1
Confusion	1/10 (10%)	1
Depression	1/10 (10%)	1
Renal and urinary disorders
Renal and urinary disorders - Other, specify	1/10 (10%)	1
Urinary incontinence	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	1/10 (10%)	1
Cough	1/10 (10%)	1
Dyspnea	2/10 (20%)	3
Epistaxis	1/10 (10%)	3
Productive cough	2/10 (20%)	2
Skin and subcutaneous tissue disorders
Alopecia	1/10 (10%)	1
Nail loss	1/10 (10%)	1
Pruritus	1/10 (10%)	1
Rash acneiform	1/10 (10%)	1
Rash maculo-papular	1/10 (10%)	1
Skin and subcutaneous tissue disorders - Other, specify	5/10 (50%)	7
Vascular disorders
Hypertension	4/10 (40%)	4

Limitations/Caveats

Study was powered to detect an 85% response rate compared to a 55% control rate. Simon's Two-Stage design planned to enroll 6 at Stage 1; if 4 or more achieved CR/PR then an additional 14 would be enrolled in Stage 2 for a total of 20 participants. Study satisfied Stage 1 requirements but lagging enrollment caused study to close with only 10 participants enrolled. Of the 10 only 9 were efficacy evaluable. Power: P(x>=8|n=9, p=0.85) = 0.599; x=success, n=evaluable, p=expected probability

More Information

Certain Agreements

All Principal Investigators ARE 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.