Metastatic Soft Tissue SarcomaPhase 2SOURCENCT01574716

Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

A Phase 2 study testing MORAb-004, Gemcitabine and Docetaxel in people with Metastatic Soft Tissue Sarcoma, run by Morphotek at 29 sites in 6 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

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Soft Tissue Sarcoma
What is being tested?: MORAb-004, Gemcitabine and Docetaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 209 participants
Where: 29 sitesin 6 countries
Study dates: 7 Aug 2012to 2 Aug 2016
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be at least 18 years of age
Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
Have tumor tissue available for TEM-1 biomarker studies
Be willing and able to provide written informed consent

Who cannot join

Have received more than 2 prior systemic treatment regimens for mSTS
Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
Have a diagnosis of primary bone sarcoma of any histological type.
Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
Have a history of allergic reaction to prior monoclonal antibody or biologic agent
Have received previous treatment with MORAb-004 (anti-TEM-1)

Show all 9Show fewer

Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture

Trial locations and contacts

29 sites in 6 countries.

Country

City, postcode or hospital

29 sites in 6 countries

United States19 sites

University of Michigan Health System
Ann Arbor, Michigan, 48109
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 2215
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern Memorial Hospital
Chicago, Illinois, 60611
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Miami
Miami, Florida, 33136
Mount Sinai Medical Center
New York, New York, 10029
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic - Rochester
Rochester, New York, 55905
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Sarcoma Oncology Center
Santa Monica, California, 90403
UCLA
Santa Monica, California, 90404
Seattle Care Alliance
Seattle, Washington
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101
Washington University
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

Australia5 sites

Canberra Hospital
Garran, Australian Capital Territory, 2605
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102

Other trials in Australia

France2 sites

Institut Gustave Roussy
Villejuif, 94805
University of Claude Bernard
Villeurbanne, 69100

Other trials in France

Belgium1 site

UZ Leuven Medical Oncology
Leuven, 3000

Other trials in Belgium

Italy1 site

Istituto Ortopedico Rizzoli
Bologna, 40136

Other trials in Italy

Netherlands1 site

Leiden University Medical Center
Leiden

Other trials in Netherlands

About this study

Official title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

Conditions: Metastatic Soft Tissue Sarcoma
Being tested: MORAb-004, Gemcitabine, Docetaxel, Placebo
Medical subject headings: Sarcoma

What participants receive

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

MORAb-004Drug
IV, Days 1 and 8 of every cycle until disease progression
GemcitabineDrug
IV, Days 1 and 8 of each cycle until disease progression
DocetaxelDrug
IV, Day 8 of every cycle until disease progression
GemcitabineDrug
IV, Days 1 and 8 of each cycle until disease progression
DocetaxelDrug
IV, Day 8 of every cycle until disease progression
PlaceboDrug

Study groups in NCT01574716
Study group	Role	What they receive
MORAb-004, gemcitabine, docetaxel	Experimental	Not described Receives: Drug: MORAb-004; Drug: Gemcitabine; Drug: Docetaxel
Placebo, gemcitabine, docetaxel	Active comparator	Not described Receives: Drug: Gemcitabine; Drug: Docetaxel; Drug: Placebo

What is being measured

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

Part 2: Radiologic Progression-free Survival (PFS)
PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
Measured: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)

Secondary outcomes (5)

Part 2: Symptomatic Progression-free Survival
PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.
Measured: From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)
Part 2: Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
Measured: From date of first dose until date of death from any cause (up to approximately 3.5 years)
Part 2: Overall Response Rate (ORR)
ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: From date of first dose until disease progression (up to approximately 3.5 years)
Part 2: Radiologic Progression-free Survival Rate (PFR)
Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
Measured: Weeks 12, 24, 48 and 52
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
Measured: Up to approximately 3 years

Timeline

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

7 Aug 20122 Aug 2016

First posted10 Apr 2012 (estimated)
Study start7 Aug 2012
Primary completion11 Aug 2015
Study completion2 Aug 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Soft Tissue SarcomaStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01574716
Sponsor's protocol ID: MORAb-004-203-STS
Other IDs: 2012-001399-12
Acronym: SOURCE
Status last verified: Nov 2016
First submitted: 4 Apr 2012
Last updated: 21 Aug 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Jones RL, Chawla SP, Attia S, Schoffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.
PubMed 31034598

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 Metastatic Soft Tissue Sarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT01574716
Acronym / sponsor ID: SOURCE / MORAb-004-203-STS
Conditions: Metastatic Soft Tissue Sarcoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: MorphotekIndustry (pharma, biotech, devices)
Study start: 7 Aug 2012 (actual)
Primary completion: 11 Aug 2015 (actual)
Study completion: 2 Aug 2016 (actual)
First posted: 10 Apr 2012 (estimated)
Results: Posted 21 Aug 2019

Clinical summary

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

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MORAb-004, gemcitabine, docetaxel	Experimental	Drug: MORAb-004, Drug: Gemcitabine, Drug: Docetaxel
Placebo, gemcitabine, docetaxel	Active comparator	Drug: Gemcitabine, Drug: Docetaxel, Drug: Placebo

Who may qualify

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

Key inclusion criteria (7 listed)

Be at least 18 years of age
Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization

Key exclusion criteria (9 listed)

Have received more than 2 prior systemic treatment regimens for mSTS
Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
Have a diagnosis of primary bone sarcoma of any histological type.
Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
Have a history of allergic reaction to prior monoclonal antibody or biologic agent

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
MORAb-004IV, Days 1 and 8 of every cycle until disease progression	Drug	MORAb-004, gemcitabine, docetaxel
GemcitabineIV, Days 1 and 8 of each cycle until disease progression	Drug	MORAb-004, gemcitabine, docetaxel
DocetaxelIV, Day 8 of every cycle until disease progression	Drug	MORAb-004, gemcitabine, docetaxel
GemcitabineIV, Days 1 and 8 of each cycle until disease progression	Drug	Placebo, gemcitabine, docetaxel
DocetaxelIV, Day 8 of every cycle until disease progression	Drug	Placebo, gemcitabine, docetaxel
Placebo	Drug	Placebo, gemcitabine, docetaxel

Primary outcome

Part 2: Radiologic Progression-free Survival (PFS)
Time frame: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.

5 secondary outcomes

Part 2: Symptomatic Progression-free Survival
Time frame: From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)
Part 2: Overall Survival (OS)
Time frame: From date of first dose until date of death from any cause (up to approximately 3.5 years)
Part 2: Overall Response Rate (ORR)
Time frame: From date of first dose until disease progression (up to approximately 3.5 years)
Part 2: Radiologic Progression-free Survival Rate (PFR)
Time frame: Weeks 12, 24, 48 and 52
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
Time frame: Up to approximately 3 years

Results and safety

Results posted to the registry on 21 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
Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel	3	0
Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel	4	0
Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel	9	0
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel	0	0
Part 2: Placebo + Gemcitabine/Docetaxel	0	0

Primary outcome: Part 2: Radiologic Progression-free Survival (PFS)

Time frame: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years). Median (95% Confidence Interval). Unit: weeks

Measure	Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel n = 139	Part 2: Placebo + Gemcitabine/Docetaxel n = 70
Value	18.7 (11.6 to 27.4)	24.1 (11.1 to 36.1)

Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel vs Part 2: Placebo + Gemcitabine/Docetaxel: Hazard Ratio (HR): 1.08 (95% CI 0.77 to 1.50), p = 0.6562, Log Rank

Population analysed: The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the IxRS.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of first dose until 45 days after last dose of study drug (approximately up to 4 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel	6 of 9 (66.7%)	9 of 9 (100%)	8 of 9
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel	106 of 140 (75.7%)	140 of 140 (100%)	76 of 140
Part 2: Placebo + Gemcitabine/Docetaxel	45 of 67 (67.2%)	66 of 67 (98.5%)	35 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31034598Jones RL, Chawla SP, Attia S, Schoffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.

Related trials for Metastatic Soft Tissue Sarcoma

RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
Not yet recruitingPhase 2
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MPNST (Malignant Peripheral Nerve Sheath Tumor)
RecruitingPhase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Advanced Solid Tumors, Ewing Sarcoma

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.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MORAb-004, Gemcitabine and Docetaxel in people with Metastatic Soft Tissue Sarcoma, run by Morphotek at 29 sites in 6 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 7 inclusion and 9 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 21 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 29 sites in United States, Australia, France, Belgium, Italy and 1 more country. 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 21 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?

Part 2: Radiologic Progression-free Survival (PFS) (time frame: From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)). 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 NCT01574716, which also lists 1 linked publication.

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 21 Aug 2019.