Prostate CancerPhase 2NCT01204710
A Study of Olaratumab (IMC-3G3) in Prostate Cancer
A Phase 2 study testing Olaratumab, Mitoxantrone and Prednisone in people with Prostate Cancer, run by Eli Lilly and Company at 40 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Olaratumab, Mitoxantrone and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 40 sitesin 7 countries
- Study dates
- Oct 2010to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
Germany11 sites
ImClone Investigational Site
Aachen, 57074
ImClone Investigational Site
Augsburg, 86150
ImClone Investigational Site
Bonn, 53177
ImClone Investigational Site
Dresden, 01307
ImClone Investigational Site
Essen, 45122
ImClone Investigational Site
Frankfurt, 60590
ImClone Investigational Site
Freiburg im Breisgau, 79106
ImClone Investigational Site
Mainz, 55131
ImClone Investigational Site
Mannheim, 68167
ImClone Investigational Site
Münster, 48149
ImClone Investigational Site
Rostock, 18055
Hungary7 sites
ImClone Investigational Site
Budapest, 1106
ImClone Investigational Site
Debrecen, 4032
ImClone Investigational Site
Kecskemét, 6000
ImClone Investigational Site
Miskolc, 3526
ImClone Investigational Site
Nyíregyháza, 4400
ImClone Investigational Site
Pécs, 7624
ImClone Investigational Site
Szeged, 6725
Spain7 sites
ImClone Investigational Site
Barcelona, 8003
ImClone Investigational Site
Barcelona, 8036
ImClone Investigational Site
Madrid, 28041
ImClone Investigational Site
Palma de Mallorca, 7014
ImClone Investigational Site
Pamplona - Navarra, 31008
ImClone Investigational Site
Sabadell - Barcelona, 8208
ImClone Investigational Site
Valencia, 46014
Italy5 sites
ImClone Investigational Site
Meldola, 47014
ImClone Investigational Site
Milan, 20123
ImClone Investigational Site
Roma, 161
ImClone Investigational Site
Rozzano, 20089
ImClone Investigational Site
Trento, 38100
Poland4 sites
ImClone Investigational Site
Krakow, 31-115
ImClone Investigational Site
Lublin, 20-090
ImClone Investigational Site
Poznan, 61-485
ImClone Investigational Site
Warsaw, 02-781
Belgium3 sites
ImClone Investigational Site
Charleroi, 6000
ImClone Investigational Site
Edegem, 2650
ImClone Investigational Site
Liège, 4000
Czechia3 sites
ImClone Investigational Site
Olomouc, 77520
ImClone Investigational Site
Prague, 12808
ImClone Investigational Site
Prague, 15006
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- Olaratumab, Mitoxantrone, Prednisone
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaratumabBiological
Also called IMC-3G3, LY3012207
15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8
MitoxantroneDrug
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)
PrednisoneDrug
5 mg orally (PO) twice daily (BID) on each day
| Study group | Role | What they receive |
|---|---|---|
| Olaratumab + Mitoxantrone | Experimental | 1 cycle = 3 weeks (21 days) Receives: Biological: Olaratumab; Drug: Mitoxantrone; Drug: Prednisone |
| Mitoxantrone: Optional Olaratumab Monotherapy | Active comparator | 1 cycle = 3 weeks (21 days)
Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment. Receives: Drug: Mitoxantrone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Secondary outcomes (10)
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.
Measured: Randomization to Death Due to Any Cause Up to 36 Months
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.
Measured: Randomization to Objective PD or Death Up to 23 Months
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.
Measured: Pretreatment to PD Up to 23 Months
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.
Measured: Pretreatment through Week 12
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.
Measured: From Start of Treatment Through Study Completion Up to 36 months
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.
Measured: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
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.
Measured: Randomization to Death Due to Any Cause Up to 36 Months
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.
Measured: Baseline
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.
Measured: From Start of Treatment up to 9 Months
Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3
Measured: Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204710
- Sponsor's protocol ID
- 13938
- Other IDs
- I5B-IE-JGDD, CP15-0805, 2009-018015-11, 2009
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2010
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01204710
- Acronym / sponsor ID
- 13938
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaratumab + Mitoxantrone | Experimental | Biological: Olaratumab, Drug: Mitoxantrone, Drug: Prednisone1 cycle = 3 weeks (21 days) |
| Mitoxantrone: Optional Olaratumab Monotherapy | Active comparator | Drug: Mitoxantrone, Drug: Prednisone1 cycle = 3 weeks (21 days) Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaratumabAlso: IMC-3G3, LY301220715 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8 | Biological | Olaratumab + Mitoxantrone |
| MitoxantroneMitoxantrone 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) | Drug | Mitoxantrone: Optional Olaratumab Monotherapy, Olaratumab + Mitoxantrone |
| Prednisone5 mg orally (PO) twice daily (BID) on each day | Drug | Mitoxantrone: Optional Olaratumab Monotherapy, Olaratumab + Mitoxantrone |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
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.
10 secondary outcomes
Overall Survival (OS)
Time frame: Randomization to Death Due to Any Cause Up to 36 Months
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Time frame: Randomization to Objective PD or Death Up to 23 Months
Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time
Time frame: Pretreatment to PD Up to 23 Months
Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12
Time frame: Pretreatment through Week 12
Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)
Time frame: From Start of Treatment Through Study Completion Up to 36 months
PFS Based on Baseline Circulating Tumor Cells (CTC) Counts
Time frame: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
OS Based on Baseline CTC Counts
Time frame: Randomization to Death Due to Any Cause Up to 36 Months
Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)
Time frame: Baseline
Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)
Time frame: From Start of Treatment up to 9 Months
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaratumab, Mitoxantrone and Prednisone in people with Prostate Cancer, run by Eli Lilly and Company at 40 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Germany, Hungary, Spain, Italy, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.