Oral MucositisPhase 2NCT02013050

A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

A Phase 2 study testing SGX942 in people with Oral Mucositis, run by Soligenix at 1 site in United States.

Completed

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

Trial summary

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oral Mucositis
What is being tested?: SGX942
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Sep 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

Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
Must be able to read and understand informed consent
Adequate birth control methods for the duration of the study

Who cannot join

Current mucositis.
Prior radiation to the head and neck.
Chemotherapy treatment within the previous 12 months.
Tumors of the lips, sinuses, salivary glands or nasopharynx.
Unknown primary tumor.
Stage 4c metastases.
Evidence of significant hepatic, hematologic, or immunologic disease.
Women who are pregnant or breast-feeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

Markey Cancer Center-University of Kentucky
Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Conditions: Oral Mucositis
Being tested: SGX942, Placebo
Medical subject headings: Stomatitis

What participants receive

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

SGX942Drug
PlaceboDrug

Study groups in NCT02013050
Study group	Role	What they receive
Placebo	Placebo comparator	Control Receives: Drug: Placebo
SGX942	Experimental	Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg Receives: Drug: SGX942

What is being measured

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

Duration of Severe Oral Mucositis (SOM)
Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.
Measured: 4 weeks after end of therapy

Secondary outcomes (8)

Residual Severe Oral Mucositis (SOM)
OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.
Measured: 4 weeks after end of therapy
Duration of Severe Oral Mucositis (SOM)
OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.
Measured: 4 weeks after end of therapy
Incidence of Clinically Reported, Non-fungal Infections
Measured: 4 weeks after end of therapy
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:
Target Lesion :
Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR
Non-Target Lesion:
Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions
Measured: 4 weeks after end of therapy
Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Measured: 4 weeks after end of therapy
Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Measured: 4 weeks after end of therapy
Survival
Measured: 12 months after end of therapy
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:
Target Lesion :
Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR
Non-Target Lesion:
Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions
Measured: 12 months after end of therapy

Timeline

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

Dec 2013Sep 2016

First posted17 Dec 2013 (estimated)
Study startDec 2013
Primary completionDec 2015
Study completionSep 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.
Other trials for Oral MucositisStudies 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: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02013050
Sponsor's protocol ID: IDR-OM-01
Status last verified: Jul 2017
First submitted: 11 Dec 2013
Last updated: 28 Aug 2017
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

Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)

All Oral Mucositis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
ClinicalTrials.gov ID: NCT02013050
Acronym / sponsor ID: IDR-OM-01
Conditions: Oral Mucositis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: SoligenixIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Dec 2015 (actual)
Study completion: Sep 2016 (actual)
First posted: 17 Dec 2013 (estimated)
Results: Posted 31 Jul 2017

Clinical summary

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

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

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
Placebo	Placebo comparator	Drug: PlaceboControl
SGX942	Experimental	Drug: SGX942Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg

Who may qualify

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

Key inclusion criteria (5 listed)

Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
Must be able to read and understand informed consent
Adequate birth control methods for the duration of the study

Key exclusion criteria (8 listed)

Current mucositis.
Prior radiation to the head and neck.
Chemotherapy treatment within the previous 12 months.
Tumors of the lips, sinuses, salivary glands or nasopharynx.
Unknown primary tumor.

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
SGX942	Drug	SGX942
Placebo	Drug	Placebo

Primary outcome

Duration of Severe Oral Mucositis (SOM)
Time frame: 4 weeks after end of therapy
Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.

8 secondary outcomes

Residual Severe Oral Mucositis (SOM)
Time frame: 4 weeks after end of therapy
Duration of Severe Oral Mucositis (SOM)
Time frame: 4 weeks after end of therapy
Incidence of Clinically Reported, Non-fungal Infections
Time frame: 4 weeks after end of therapy
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
Time frame: 4 weeks after end of therapy
Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Time frame: 4 weeks after end of therapy
Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Time frame: 4 weeks after end of therapy
Survival
Time frame: 12 months after end of therapy
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
Time frame: 12 months after end of therapy

Results and safety

Results posted to the registry on 31 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	42	38
1.5 mg/kg	41	36
3.0 mg/kg	3	3
6.0 mg/kg	23	19

Primary outcome: Duration of Severe Oral Mucositis (SOM)

Time frame: 4 weeks after end of therapy. Median (95% Confidence Interval). Unit: days

Measure	Placebo n = 38	1.5 mg/kg n = 36	3.0 mg/kg n = 3	6.0 mg/kg n = 19
Value	18 (5 to 36)	9 (3 to 19)	14 (0 to NA)	22 (3 to 36)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of enrollment up until four weeks (±5 days) following the last study drug treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	25 of 41 (61%)	41 of 41 (100%)	8 of 43
1.5 mg/kg	25 of 42 (59.5%)	42 of 42 (100%)	3 of 41
3.0 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
6.0 mg/kg	16 of 23 (69.6%)	23 of 23 (100%)	4 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Oral Mucositis

Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SGX942 in people with Oral Mucositis, run by Soligenix at 1 site in United States.

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 5 inclusion and 8 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 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 31 Jul 2017). 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?

Duration of Severe Oral Mucositis (SOM) (time frame: 4 weeks after end of therapy). 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 NCT02013050.

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 28 Aug 2017.