Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00466960
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 21
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous chemotherapy

Condition or Disease	Intervention/Treatment	Phase
Brenner Tumor; Fallopian Tube Cancer; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer	Biological: sargramostim; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: laboratory biomarker analysis; Other: immunologic technique	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine whether chronic GM-CSF administration during and after cytotoxic chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer remission than experienced in the most recent platinum-containing regimen.

SECONDARY OBJECTIVES:

1. To determine the extent to which chronic GM-CSF administration can increase the number of activated monocytes in patients with advanced stage epithelial ovarian cancer.

2. To determine the extent to which chronic GM-CSF administration can increase the number and activation state of peripheral circulating antigen presenting cells, such as dendritic cells and activated monocytes, in patients with advanced epithelial ovarian cancer.

3. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of T cells that recognize tumor specific antigens in patients with advanced stage epithelial ovarian cancer.

4. To determine the extent to which chronic GM-CSF administration can increase the number and functional status of antigen specific T cells that recognize foreign pathogens in patients with advanced stage epithelial ovarian cancer.

OUTLINE:

INDUCTION THERAPY: Patients receive GM-CSF subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 6 months and then every 3 months thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Jul 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (colony stimulating factor and chemotherapy) INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Biological: sargramostim; Given SC; Other Names: GM-CSF Leukine Prokine ; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Given IV; Other Names: ABI-007 nab paclitaxel nab-paclitaxel nanoparticle albumin-bound paclitaxel ; Other: laboratory biomarker analysis; Correlative studies; Other: immunologic technique; Correlative studies; Other Names: immunological laboratory methods laboratory methods, immunological

Outcome Measures

Primary Outcome Measures

1. Time to Progression [Up to 5 years]

   Median time to progression

2. Response Rate [Up to 5 years]

   Number of patients achieving a complete or partial response.

Secondary Outcome Measures

1. Correlation Between Circulating Monocytes and Time to Progression [Up to 5 years]

   Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).

2. Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration [Up to 5 years]

   Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).

3. Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens [Up to 5 years]

   Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.

4. Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens [Up to 5 years]

   Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients must have histologically proven epithelial ovarian, fallopian tube or primary peritoneal malignancies, excluding tumors of low malignant potential (borderline)

• Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified

• Patients must have either primary platinum refractory or resistant carcinoma or secondary platinum resistant disease:

1. Primary platinum refractory disease is defined as progression of disease on initial platinum-based chemotherapy or persistent disease at the conclusion of the initial platinum-based chemotherapy course associated with the primary debulking surgery.

2. Primary platinum resistant disease is defined as recurrence of carcinoma within 6 months (+ 14 days) of completion of initial platinum-based chemotherapy associated with the primary debulking surgery. (The 14 day window is to allow study entry for those patients where evidence clearly suggests that had an assessment been made early the patient would have met the 6 month time line. This will be determined by the study principal investigator [P.I.])

3. Secondary platinum resistant disease is defined as meeting any one of the listed criteria during or following a subsequent platinum containing regimen.

• Patients must have an elevated serum cancer antigen (CA)125 on two occasions greater than 7 days apart

• Absolute neutrophil count >= 1500/uL

• Platelets >= 100,000/uL

• Creatinine =< 2.0 mg/dL

• Total bilirubin =< 1.5 mg/dL (unless history of Gilbert's disease)

• Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN with documented report of hepatic metastases

• Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least three weeks must have elapsed since prior chemotherapy or radiation therapy

Exclusion Criteria:

• Patient has an allergic history to paclitaxel or GM-CSF, not manageable by pre-medication and/or slow drug infusion

• Patient has poorly controlled arrhythmias or unstable coronary artery disease or has had a myocardial infarction within the last six months

• Patient with active pulmonary edema or pleural effusion

• Active infection requiring IV antibiotics

• Patient currently requires lithium, (due to drug interaction with GM-CSF [Leukine])

• Patient currently presents with a neurotoxicity > Grade 1

• Women of childbearing potential

• Patients with a history of other invasive malignancies, within the previous 5 years are excluded, with the exception of non-melanoma skin cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• University of Washington
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Barbara Goff, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barbara Goff, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT00466960
• Other Study ID Numbers: 6168; NCI-2010-00556
• First Posted: Apr 27, 2007
• Last Update Posted: Aug 28, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Adenocarcinoma; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma; Cystadenocarcinoma, Serous; Cystadenocarcinoma, Mucinous; Carcinoma; Brenner Tumor; Paclitaxel; Albumin-Bound Paclitaxel; Sargramostim

Study Results

Participant Flow

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) subcutaneously (SC) once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Period Title: Overall Study
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Overall Participants	21
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61
Sex: Female, Male (Count of Participants)
Female	21 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.8%
Not Hispanic or Latino	20 95.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	20 95.2%
More than one race	1 4.8%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Time to Progression
Description	Median time to progression
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Measure Participants	21
Median (95% Confidence Interval) [months]	4.07

2. Primary Outcome

Title	Response Rate
Description	Number of patients achieving a complete or partial response.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Measure Participants	21
Count of Participants [Participants]	15 71.4%

3. Secondary Outcome

Title	Correlation Between Circulating Monocytes and Time to Progression
Description	Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD).
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Measure Participants	21
CR	20.75
PR+NR+SD	12.75

4. Secondary Outcome

Title	Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration
Description	Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD).
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Measure Participants	21
mDC in CR	1.543
mDC in PR+NR+SD	1.996
pDC in CR	0.2465
pDC in PR+NR+SD	0.3743

5. Secondary Outcome

Title	Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens
Description	Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Measure Participants	21
IGF1R-p1196-1210	0.5056
IGF1R-p1242-1256	0.8496
IGF1R-p1332-1346	0.8269
IGFBP2	0.3676
p53	-0.02268
PRAME	-0.0817

6. Secondary Outcome

Title	Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens
Description	Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
Measure Participants	21
PHA	-0.08759
CEF	-0.1818
tetanus toxoid	-0.1071

Adverse Events

Arm/Group Title	Treatment (Colony Stimulating Factor and Chemotherapy)
Arm/Group Description	INDUCTION THERAPY: Patients receive GM-CSF SC once daily on days 16-26. Patients also receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. sargramostim: Given SC paclitaxel albumin-stabilized nanoparticle formulation: Given IV laboratory biomarker analysis: Correlative studies immunologic technique: Correlative studies
All Cause Mortality
	Treatment (Colony Stimulating Factor and Chemotherapy)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Colony Stimulating Factor and Chemotherapy)
	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)
Gastrointestinal disorders
Nausea	2/21 (9.5%)	2
Vomiting	2/21 (9.5%)	2
Obstruction, GI	1/21 (4.8%)	1
General disorders
Abdomen NOS	1/21 (4.8%)	1
Other (Not Including Serious) Adverse Events
	Treatment (Colony Stimulating Factor and Chemotherapy)
	Affected / at Risk (%)	# Events
Total	20/21 (95.2%)
Blood and lymphatic system disorders
Low HCT	2/21 (9.5%)
Hematocrit	3/21 (14.3%)
RBC	2/21 (9.5%)
Hemoglobin	13/21 (61.9%)
Leukocytes (total WBC)	11/21 (52.4%)
Lymphopenia	6/21 (28.6%)
Neutrophils/granulocytes (ANC/AGC)	6/21 (28.6%)
Platelets	2/21 (9.5%)
Edema:limb	5/21 (23.8%)
Cardiac disorders
Hypertension	2/21 (9.5%)
Ear and labyrinth disorders
Tinnitus	2/21 (9.5%)
Gastrointestinal disorders
Anorexia	5/21 (23.8%)
Constipation	3/21 (14.3%)
Diarrhea	4/21 (19%)
Mucositis/stomatitis (functional/symptomatic)	2/21 (9.5%)
Nausea	6/21 (28.6%)
Vomiting	7/21 (33.3%)
General disorders
Fatigue (asthenia, lethargy, malaise)	9/21 (42.9%)
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	2/21 (9.5%)
Rigors/Chills	2/21 (9.5%)
Weight Gain	2/21 (9.5%)
Weight Loss	2/21 (9.5%)
Death not associated with CTCAE term	4/21 (19%)
Memory Impairment	2/21 (9.5%)
Somnolence/depressed level of consciousness	2/21 (9.5%)
Arthralgia (Pain)	2/21 (9.5%)
Bone Pain	4/21 (19%)
Head pain/Headache	4/21 (19%)
Joint Pain	2/21 (9.5%)
Muscle Pain	3/21 (14.3%)
Myalgia (Pain)	2/21 (9.5%)
Flu-like syndrome	4/21 (19%)
Immune system disorders
Allergic Reaction/Hypersensitivity (Including drug fever)	2/21 (9.5%)
Metabolism and nutrition disorders
Hypoalbuminemia	7/21 (33.3%)
Hypocalcemia	2/21 (9.5%)
GFR	2/21 (9.5%)
Low Protein	2/21 (9.5%)
Hypokalemia	5/21 (23.8%)
Hyponatremia	5/21 (23.8%)
Renal and urinary disorders
Urinary Retention (including neurogenic bladder)	2/21 (9.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	3/21 (14.3%)
Skin and subcutaneous tissue disorders
Dry Skin	3/21 (14.3%)
Hair loss/alopecia (scalp or body)	7/21 (33.3%)
Injection site reaction/extravasation changes	6/21 (28.6%)
Nail Changes	3/21 (14.3%)
Rash: Acne/Acneiform	2/21 (9.5%)

Limitations/Caveats

[Not Specified]

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.