Soft Tissue SarcomaPhase 1NCT02783599

A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma

A Phase 1 study testing Olaratumab, Doxorubicin and External Beam Radiotherapy in people with Soft Tissue Sarcoma, run by Eli Lilly and Company at 14 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Soft Tissue Sarcoma
What is being tested?: Olaratumab, Doxorubicin and External Beam Radiotherapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 14 sitesin 5 countries
Study dates: 11 Oct 2016to 5 Jul 2018
Phase: Phase 1
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of the extremities, Grade 2 or 3, >5 centimeters, for which olaratumab and radiotherapy would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid liposarcoma will be excluded.
Have consented to undergo mandatory serial peripheral whole blood and tumor tissue sampling.

Who cannot join

Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. 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 enrollment to rule out brain metastasis.
Have received 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.
For radiotherapy addendum only: Have received previous radiotherapy in the primary tumor lesion and/or prior treatment with olaratumab or has participated in a prior olaratumab trial.

Trial locations and contacts

14 sites in 5 countries.

Country

City, postcode or hospital

14 sites in 5 countries

United States9 sites

Levine Children's Hospital
Charlotte, North Carolina, 28203
Mary Crowley Cancer Research
Dallas, Texas, 75230
USC/Norris Comp Cancer Center
Los Angeles, California, 90033
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Kansas City Cancer Center
Overland Park, Kansas, 66210
Washington University Medical Center
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
Moffitt Cancer Center & Research Inst
Tampa, Florida, 33612

Other trials in United States

Spain2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, 08025
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seville, 41013

Other trials in Spain

France1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lyon, 69373

Other trials in France

Italy1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Milan, 20133

Other trials in Italy

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, SW3 6JJ

Other trials in United Kingdom

About this study

Official title: A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy

The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).

Conditions: Soft Tissue Sarcoma
Being tested: Olaratumab, Doxorubicin, External Beam Radiotherapy
Medical subject headings: Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlaratumabDrug
Also called LY3012207
Administered IV
DoxorubicinDrug
Administered IV
External Beam RadiotherapyRadiation

Study groups in NCT02783599
Study group	Role	What they receive
Olaratumab + Doxorubicin	Experimental	Cycle 1: Olaratumab 20 milligram per kilogram (mg/kg) given intravenously (IV) on Day 1 and Day 8 (21 day cycle). Cycle 2: Olaratumab 20 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycle). Cycle 3 through Cycle 7: Olaratumab 15 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycles). Receives: Drug: Olaratumab; Drug: Doxorubicin
Olaratumab + Radiotherapy Addendum	Experimental	Olaratumab given IV on Day 1 and Day 8 (21 day cycle) concurrently with radiotherapy. Radiotherapy addendum was not implemented. Receives: Drug: Olaratumab; Radiation: External Beam Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood
Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.
Measured: Baseline, End of Cycle 1 (21 days)
Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue
Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα.
Measured: Baseline, End of Cycle 1 (21 days)
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β.
Measured: Baseline, End of Cycle 1 (21 days)

Secondary outcomes (7)

Progression Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of first study dose to the first date of radiologic disease progression or death due to any cause. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.
Measured: Baseline to Objective Progression or Death from Any Cause (Up to 18 Months)
Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)
Overall Response Rate (ORR) is defined as the percentage of participants achieving a best overall response of either Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. The best overall response is the best response from the start of the treatment until progressive disease (PD)/recurrence.
Measured: Baseline to Measured Progressive Disease (Up to 18 Months)
Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
Participants who do not have any post-baseline tumor response assessments for any reason are considered non-responders and are included in the denominator when calculating the response rate.
Measured: Baseline to Measured Progressive Disease (Up to 18 Months)
Percentage of Participants With Resectable Tumors (Resectability Rate)
Resectability rate is obtained when the total number of participants with resectable tumors is divided by the total number of participants. Resectability of a tumor is determined by the surgeon and multi-disciplinary team and dependent on tumor stage and the participants coexisting medical conditions.
Measured: Cycle 1 through Cycle 7 (Up to 6 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy
Summary of Cmax of olaratumab monotherapy on Cycle 1 Day 1 and Day 8
Measured: Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusion
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Cmax of olaratumab Cycles 2 and 3 Day 1 and 8 of a 21-day cycle.
Measured: Cycle 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusion
Number of Participants With Anti-Olaratumab Antibodies
A participant is counted as positive if they had at least one anti-olaratumab antibody positive result during the study.
Measured: Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 20165 Jul 2018

First posted26 May 2016 (estimated)
Study start11 Oct 2016
Primary completion5 Jul 2018
Study completion5 Jul 2018

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 Soft Tissue SarcomaStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783599
Sponsor's protocol ID: 15840
Other IDs: I5B-MC-JGDM, 2015-005018-31, 2015
Status last verified: Feb 2019
First submitted: 24 May 2016
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Soft Tissue Sarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy
ClinicalTrials.gov ID: NCT02783599
Acronym / sponsor ID: 15840
Conditions: Soft Tissue Sarcoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 11 Oct 2016 (actual)
Primary completion: 5 Jul 2018 (actual)
Study completion: 5 Jul 2018 (actual)
First posted: 26 May 2016 (estimated)
Results: Posted 12 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Olaratumab + Doxorubicin	Experimental	Drug: Olaratumab, Drug: DoxorubicinCycle 1: Olaratumab 20 milligram per kilogram (mg/kg) given intravenously (IV) on Day 1 and Day 8 (21 day cycle). Cycle 2: Olaratumab 20 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycle). Cycle 3 through Cycle 7: Olaratumab 15 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycles).
Olaratumab + Radiotherapy Addendum	Experimental	Drug: Olaratumab, Radiation: External Beam RadiotherapyOlaratumab given IV on Day 1 and Day 8 (21 day cycle) concurrently with radiotherapy. Radiotherapy addendum was not implemented.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy.
For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of the extremities, Grade 2 or 3, >5 centimeters, for which olaratumab and radiotherapy would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid liposarcoma will be excluded.
Have consented to undergo mandatory serial peripheral whole blood and tumor tissue sampling.

Key exclusion criteria (3 listed)

Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. 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 enrollment to rule out brain metastasis.
Have received 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.
For radiotherapy addendum only: Have received previous radiotherapy in the primary tumor lesion and/or prior treatment with olaratumab or has participated in a prior olaratumab trial.

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: LY3012207Administered IV	Drug	Olaratumab + Doxorubicin, Olaratumab + Radiotherapy Addendum
DoxorubicinAdministered IV	Drug	Olaratumab + Doxorubicin
External Beam Radiotherapy	Radiation	Olaratumab + Radiotherapy Addendum

Primary outcome

Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood
Time frame: Baseline, End of Cycle 1 (21 days)
Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.
Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue
Time frame: Baseline, End of Cycle 1 (21 days)
Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα.
Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue
Time frame: Baseline, End of Cycle 1 (21 days)
PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β.

7 secondary outcomes

Progression Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death from Any Cause (Up to 18 Months)
Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)
Time frame: Baseline to Measured Progressive Disease (Up to 18 Months)
Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR
Time frame: Baseline to Measured Progressive Disease (Up to 18 Months)
Percentage of Participants With Resectable Tumors (Resectability Rate)
Time frame: Cycle 1 through Cycle 7 (Up to 6 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy
Time frame: Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusion
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab
Time frame: Cycle 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusion
Number of Participants With Anti-Olaratumab Antibodies
Time frame: Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months)

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olaratumab + Doxorubicin	51	11

Primary outcome: Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood

Time frame: Baseline, End of Cycle 1 (21 days). Mean (Standard Deviation). Unit: percent change

Measure	Olaratumab n = 35
Traditional CTCs	846.93 (3260.60)
All Population CTCs	820.11 (3263.41)

Population analysed: All participants who received one cycle of study drug and had evaluable blood samples for CTCs at baseline and post-olaratumab monotherapy.

Primary outcome: Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue

Time frame: Baseline, End of Cycle 1 (21 days). Mean (Standard Deviation). Unit: percent change in gene expression

Measure	Olaratumab n = 37
PDGF Receptor α	6162.86 (32383.49)
PDGF Receptor β	1246.25 (7024.82)

Population analysed: All participants who received at least one dose of study drug and had evaluable tissue samples at baseline and post-olaratumab monotherapy.

Primary outcome: Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue

Time frame: Baseline, End of Cycle 1 (21 days). Mean (Standard Deviation). Unit: percent change in gene expression

Measure	Olaratumab n = 37
Canonical Ligand PDGF - A	189.37 (672.91)
Canonical Ligand PDGF - B	602.01 (2798.92)
Canonical Ligand PDGF - C	1107.45 (6053.12)
Canonical Ligand PDGF - D	2630.36 (14425.92)

Population analysed: All participants who received at least one dose of study drug and had evaluable baseline tissue samples at baseline and post-olaratumab monotherapy.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of study (Up to 46 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olaratumab + Doxorubicin	22 of 51 (43.1%)	50 of 51 (98%)	3 of 51

Limitations and caveats (from the sponsor): Radiotherapy addendum was not implemented due to business decisions. There were no safety or efficacy issues related to the addendum that contributed to this decision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for more information about this study: A Study of Olaratumab (LY3012207) in Participants With Soft Tissue SarcomaLink provided by the sponsor.

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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

14 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olaratumab, Doxorubicin and External Beam Radiotherapy in people with Soft Tissue Sarcoma, run by Eli Lilly and Company at 14 sites in 5 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 3 inclusion and 3 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Spain, France, Italy, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 12 Aug 2019). 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?

Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood (time frame: Baseline, End of Cycle 1 (21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783599.

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 12 Aug 2019.