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A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (ANNOUNCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02451943
First received: May 20, 2015
Last updated: November 22, 2016
Last verified: November 2016
  Purpose
The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.

Condition Intervention Phase
Soft Tissue Sarcoma Drug: Olaratumab Drug: Doxorubicin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization to Date of Death Due to Any Cause (Estimated Up to 45 Months) ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Randomization to Objective Progression or Death Due to Any Cause (Estimated Up to 45 Months) ]
  • Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) [ Time Frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated up to 45 Months) ]
  • Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) [ Time Frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated up to 45 Months) ]
  • Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Scores [ Time Frame: Randomization through Follow-up (Estimated up to 45 Months) ]
  • Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) [ Time Frame: Randomization through Follow-up (Estimated up to 45 Months) ]
  • Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [ Time Frame: Randomization through Follow-up (Estimated up to 45 Months) ]
  • Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 45 Months) ]
  • Duration of Disease Control (DDC) [ Time Frame: Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Estimated up to 45 Months) ]
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) Prior to 4th cycle of Olaratumab [ Time Frame: Pre-dose Day 1 of Cycle 4 (21 Day Cycles) ]

Estimated Enrollment: 460
Study Start Date: September 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxorubicin + Olaratumab
75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
Drug: Olaratumab
Administered IV
Other Name: LY3012207
Drug: Doxorubicin
Administered IV
Placebo Comparator: Doxorubicin + Placebo
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
Drug: Doxorubicin
Administered IV
Drug: Placebo
Administered IV

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for participants that are not newly diagnosed.
  • Presence of measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Eisenhauer et al. 2009).
  • Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • The participant has not received any previous treatment with anthracyclines.
  • The participant may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease and are considered appropriate candidates for anthracycline therapy. All previous anticancer treatments must be completed ≥ 3 weeks (21 days) prior to first dose of study drug.
  • Availability of tumor tissue is required for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin embedded (FFPE) tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
  • Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.
  • Left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to randomization.
  • Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
  • Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug.
  • The participant has, in the opinion of the investigator, a life expectancy of at least 3 months.

Exclusion Criteria:

  • Diagnosis of GIST or Kaposi sarcoma.
  • Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of randomization. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before randomization to rule out brain metastasis.
  • Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
  • Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
  • The participant has symptomatic congestive heart failure (CHF), left ventricular dysfunction (LVEF < 50%), severe myocardial insufficiency, cardiac arrhythmia, or cardiomyopathy.
  • The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of randomization.
  • The participant has a QT interval calculated using Bazett's formula (QTcB) interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG).
  • Females who are pregnant or breastfeeding.
  • Known allergy to any of the treatment components including a history of allergic reactions attributed to compounds of chemical or biological composition similar to olaratumab.
  • The participant has a known active fungal, bacterial, or viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02451943

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-0269
University of California-San Diego
La Jolla, California, United States, 92037-0845
UCLA Medical Center
Los Angeles, California, United States, 90024
Stanford University
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida School of Medicine
Gainesville, Florida, United States, 32608
Mayo Clinic of Jacksonville
Jacksonville, Florida, United States, 32224
Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Georgia Cancer Specialists PC
Atlanta, Georgia, United States, 30341
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Kaiser Foundation Hospitals
Honolulu, Hawaii, United States, 96819
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Columbia University
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Carolinas Healthcare System
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
University of Pittsburgh Medical Center
Pittsburg, Pennsylvania, United States, 15232
United States, South Carolina
Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
The West Clinic
Germantown, Tennessee, United States, 38138
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84112
United States, Virginia
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, United States, 22031
United States, Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, United States, 53792-4108
Argentina
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Buenos Aires, Argentina, 1025
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Rosario, Argentina, S2002KDS
Australia
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Camperdown, Australia, 2050
Austria
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Wien, Austria, 1090
Belgium
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Brussels, Belgium, 1200
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Brazil
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Rio de Janeiro, Brazil, 20220-410
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Sao Paulo, Brazil, 01246000
Canada
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Calgary, Canada, T2N 4N2
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Edmonton, Canada, T6G 1Z2
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Montreal, Canada, H4A 3J1
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Toronto, Canada, M5G 2M9
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Vancouver, Canada, V5Z 4E6
Denmark
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Aarhus, Denmark, 8000
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Herlev, Denmark, 2730
Finland
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Tampere, Finland, 33521
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Turku, Finland, SF-20520
France
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Bordeaux, France, 33076
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Dijon, France, 21034
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Lyon, France, 69373
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Marseille, France, 13385
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Paris, France, 75248
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Rennes, France, 35042
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Toulouse, France, 31059
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Villejuif, France, 94805
Germany
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Berlin, Germany, 13125
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Essen, Germany, 45122
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Mannheim, Germany, 68167
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Munchen, Germany, 81377
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Tubingen, Germany, 72076
Hungary
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Budapest, Hungary, 1062
Israel
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Jerusalem, Israel, 9112001
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Tel Aviv Jaffa, Israel, 6423906
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Tel Hashomer, Israel, 5265601
Italy
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Catania, Italy, 95125
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Milano, Italy, 20133
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Terni, Italy, 05100
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Torino, Italy, 10060
Japan
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Chuo-Ku, Japan, 104-0045
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Fukuoka, Japan, 811-1395
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Hidaka, Japan, 350-1298
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Kashiwa, Japan, 277 8577
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Koto-ku, Japan, 135-8550
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Nagoya, Japan, 466-8560
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Okayama, Japan, 700-8558
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Osaka, Japan, 537-8511
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Sapporo, Japan, 003-0804
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Suita-shi, Japan, 565-0871
Korea, Republic of
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Gangnam-gu, Korea, Republic of, 06351
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Ilsandong-gu, Korea, Republic of, 410-769
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Seodaemun-gu, Korea, Republic of, 120-792
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Songpa-gu, Korea, Republic of, 05505
Mexico
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Guadalajara, Mexico, 44200
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Merida, Mexico, 97138
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Monterrey, Mexico, 64320
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San Luis Potosi, Mexico, 78213
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Tijuana, Mexico, 22010
Netherlands
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Groningen, Netherlands, 9713 GZ
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Leiden, Netherlands, 2333 ZA
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Maastricht, Netherlands, 6229 HX
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3075 EA
Poland
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Warszawa, Poland, 02-781
Russian Federation
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Kazan, Russian Federation, 420029
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Moscow, Russian Federation, 115478
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St. Petersburg, Russian Federation, 197758
Spain
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Barcelona, Spain, 08907
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Madrid, Spain, 28041
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Sevilla, Spain, 41013
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Valencia, Spain, 46026
Sweden
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Lund, Sweden, 22185
Switzerland
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Bern, Switzerland, 3010
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St Gallen, Switzerland, 9007
Taiwan
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Taipei, Taiwan, 10048
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Taoyuan Hsien, Taiwan, 333
United Kingdom
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Bebington, United Kingdom, CH63 4JY
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London, United Kingdom, NW1 2BU
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Manchester, United Kingdom, M20 4BX
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Sheffield, United Kingdom, S10 2SJ
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Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02451943     History of Changes
Other Study ID Numbers: 15677
I5B-MC-JGDJ ( Other Identifier: Eli Lilly and Company )
2015‐000134‐30 ( EudraCT Number )
Study First Received: May 20, 2015
Last Updated: November 22, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
leiomyosarcoma
soft tissue sarcoma (STS)
advanced soft tissue sarcoma
metastatic soft tissue sarcoma
liposarcoma
undifferentiated pleomorphic sarcoma
doxorubicin

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017