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A Study of Olaratumab (IMC-3G3) in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Olaratumab
Mitoxantrone
Prednisone
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically-confirmed adenocarcinoma of the prostate
  • radiographic evidence of metastatic prostate cancer (Stage M1 or D2)
  • has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of <50 nanograms per milliliter (ng/mL)
  • has had disease progression or intolerance on docetaxel-based therapy
  • prostate-specific antigen (PSA) ≥10 ng/mL
  • all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.02
  • participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • adequate hematologic function
  • adequate hepatic function
  • adequate renal function
  • urinary protein is ≤1 on dipstick or routine analysis
  • life expectancy of more than 3 months
  • fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
  • signed Informed Consent Document

Exclusion Criteria:

  • concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
  • The participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
  • prior therapy with mitoxantrone for advanced prostate cancer
  • The participant has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥10% below the lower limit of normal institutional range
  • history of prior treatment with other agents that directly inhibit platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR)
  • known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone
  • radiotherapy within 21 days prior to first dose of olaratumab
  • any investigational therapy within 30 days of randomization
  • is receiving corticosteroids at a dose >5 mg prednisone PO BID or equivalent
  • received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
  • has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
  • known or suspected brain or leptomeningeal metastases
  • known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness

Sites / Locations

  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site
  • ImClone Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olaratumab + Mitoxantrone

Mitoxantrone: Optional Olaratumab Monotherapy

Arm Description

1 cycle = 3 weeks (21 days)

1 cycle = 3 weeks (21 days) Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment.

Secondary Outcome Measures

Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive.
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100.
Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time
Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100.
Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12
Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100.
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)
Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
PFS Based on Baseline Circulating Tumor Cells (CTC) Counts
High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause.
OS Based on Baseline CTC Counts
HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause.
Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)
PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with "positive" and "negative" expression. "Positive" corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. "Negative" corresponds to staining that does not meet these requirements.
Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)
Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3

Full Information

First Posted
September 16, 2010
Last Updated
September 5, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01204710
Brief Title
A Study of Olaratumab (IMC-3G3) in Prostate Cancer
Official Title
A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olaratumab + Mitoxantrone
Arm Type
Experimental
Arm Description
1 cycle = 3 weeks (21 days)
Arm Title
Mitoxantrone: Optional Olaratumab Monotherapy
Arm Type
Active Comparator
Arm Description
1 cycle = 3 weeks (21 days) Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.
Intervention Type
Biological
Intervention Name(s)
Olaratumab
Other Intervention Name(s)
IMC-3G3, LY3012207
Intervention Description
15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1 Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
5 mg orally (PO) twice daily (BID) on each day
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment.
Time Frame
Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive.
Time Frame
Randomization to Death Due to Any Cause Up to 36 Months
Title
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Description
Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100.
Time Frame
Randomization to Objective PD or Death Up to 23 Months
Title
Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time
Description
Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100.
Time Frame
Pretreatment to PD Up to 23 Months
Title
Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12
Description
Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100.
Time Frame
Pretreatment through Week 12
Title
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)
Description
Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
Time Frame
From Start of Treatment Through Study Completion Up to 36 months
Title
PFS Based on Baseline Circulating Tumor Cells (CTC) Counts
Description
High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause.
Time Frame
Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Title
OS Based on Baseline CTC Counts
Description
HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Randomization to Death Due to Any Cause Up to 36 Months
Title
Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)
Description
PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with "positive" and "negative" expression. "Positive" corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. "Negative" corresponds to staining that does not meet these requirements.
Time Frame
Baseline
Title
Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)
Description
Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Time Frame
From Start of Treatment up to 9 Months
Title
Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3
Time Frame
Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle)
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Died During Study
Time Frame
From Start of Treatment through Study Completion up to 36 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically-confirmed adenocarcinoma of the prostate radiographic evidence of metastatic prostate cancer (Stage M1 or D2) has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of <50 nanograms per milliliter (ng/mL) has had disease progression or intolerance on docetaxel-based therapy prostate-specific antigen (PSA) ≥10 ng/mL all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.02 participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 adequate hematologic function adequate hepatic function adequate renal function urinary protein is ≤1 on dipstick or routine analysis life expectancy of more than 3 months fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study signed Informed Consent Document Exclusion Criteria: concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms The participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease prior therapy with mitoxantrone for advanced prostate cancer The participant has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥10% below the lower limit of normal institutional range history of prior treatment with other agents that directly inhibit platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR) known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone radiotherapy within 21 days prior to first dose of olaratumab any investigational therapy within 30 days of randomization is receiving corticosteroids at a dose >5 mg prednisone PO BID or equivalent received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders known or suspected brain or leptomeningeal metastases known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
ImClone Investigational Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
ImClone Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
ImClone Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
ImClone Investigational Site
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
ImClone Investigational Site
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
ImClone Investigational Site
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
ImClone Investigational Site
City
Aachen
ZIP/Postal Code
57074
Country
Germany
Facility Name
ImClone Investigational Site
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
ImClone Investigational Site
City
Bonn
ZIP/Postal Code
53177
Country
Germany
Facility Name
ImClone Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
ImClone Investigational Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
ImClone Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
ImClone Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
ImClone Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
ImClone Investigational Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
ImClone Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
ImClone Investigational Site
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Facility Name
ImClone Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
ImClone Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
ImClone Investigational Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
ImClone Investigational Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
ImClone Investigational Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
ImClone Investigational Site
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
ImClone Investigational Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
ImClone Investigational Site
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
ImClone Investigational Site
City
Milano
ZIP/Postal Code
20123
Country
Italy
Facility Name
ImClone Investigational Site
City
Roma
ZIP/Postal Code
161
Country
Italy
Facility Name
ImClone Investigational Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
ImClone Investigational Site
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
ImClone Investigational Site
City
Kraków
ZIP/Postal Code
31-115
Country
Poland
Facility Name
ImClone Investigational Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
ImClone Investigational Site
City
Poznań
ZIP/Postal Code
61-485
Country
Poland
Facility Name
ImClone Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
ImClone Investigational Site
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
ImClone Investigational Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
ImClone Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
ImClone Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
7014
Country
Spain
Facility Name
ImClone Investigational Site
City
Pamplona - Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
ImClone Investigational Site
City
Sabadell - Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
ImClone Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study of Olaratumab (IMC-3G3) in Prostate Cancer

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