Head and Neck Squamous Cell CarcinomaPhase 1/2NCT02949700

Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

A Phase 1/2 study testing Metformin in people with Head and Neck Squamous Cell Carcinoma, run by Baylor College of Medicine at 3 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Head and Neck Squamous Cell Carcinoma
What is being tested?: Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 3 sitesUnited States
Study dates: 26 Jan 2017to 7 Jul 2022
Phase: Phase 1/2
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

Diagnosis: Patients must have histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx. Patients eligible for inclusion must have stage III-IV SCC of the above sites based on current AJCC clinical and imaging based staging (see Appendix A for staging criteria). For the phase II component, patients should present with: 1) HPV- SCC or 2) HPV+ SCC and a concomitant ≥10pack-year smoking history documented in the clinical record; HPV status will be ascertained using the currently utilized clinical standard of p16 overexpression via immunohistochemistry for all patients. Immunohistochemistry to determine p16 overexpression is only a requirement for oropharyngeal disease.
Disease Status: Only patients with active, measurable disease will be included in the study.
Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Patients treated with chemotherapy (i.e. cisplatin) and/or EBRT for a cancer at a different, non-head and neck site, will be eligible for the trial. Patients previously treated with chemotherapy and/or EBRT for a cancer of the head and neck region, irrespective of histology will not be eligible to participate in the trial.
Myelosuppressive chemotherapy: Must not have received within 4 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor.
Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.

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Monoclonal Antibody: At least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody.
Other: For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
XRT: >/= 14days for local palliative XRT (small port); >/= 90days must have elapsed if prior TBI, craniospinal XRT or if >/= 50% radiation of pelvis; >/= 45days must have elapsed if other substantial bone marrow radiation.
Stem Cell Transplant or Rescue: No evidence of active graft vs. host disease and >/= 2 months must have elapsed since transplant.
Age: Patients must be >/=18 years of age. Because no dosing or adverse event data are currently available on the use of metformin in cancer patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
Performance Status: ECOG performance status less than or equal to 3.
Organ Function: Patients must have normal organ and marrow function as defined below:
leukocytes >/= 3,000/mcL
absolute neutrophil count >/= 1,500/mcL
platelets >/= 100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT) </= 2.5X institutional upper limit of normal
creatinine < 1.5mg/dL OR
creatinine clearance >/= 60 mL/min/1.73 m2 for patients with creatinine levels > institutional normal
Patients must be candidates for standard of care treatment consisting of chemotherapy (cisplatin) and radiation.
Willingness to Use Contraception: The effects of metformin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Informed Consent: Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

Concomitant Medications: Patients may not be receiving any other investigational agents.
Brain metastases: Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Prior Allergies: History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin.
Patients with diabetes mellitus (DM) will be excluded from the study. Criteria for a diagnosis of diabetes mellitus are as follows: a) known diagnosis of DM, b) active treatment for DM, c) fasting glucose level ≥ 126mg/dl or d) hemoglobin A1c ≥ 6.0% obtained within 30 days prior to registration.
Intercurrent Illness: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnancy: Patients may not be pregnant or breastfeeding.

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HIV: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with metformin. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Patients taking metformin for any reason will not be eligible for inclusion in the study.
Patients may not have been treated for another SCC of the oral cavity, oropharynx, hypopharynx or larynx in the past.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Baylor College of Medicine
Houston, Texas, 77030
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
Harris Health System - Smith Clinic
Houston, Texas, 77054

Other trials in United States

About this study

Official title: A Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

The purpose of this research is to see whether metformin can improve the response rate in patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the effects, good and bad, of metformin therapy for this disease. Researchers will also analyze tumor and blood samples from study patients to test and understand the characteristics of tumors which respond to metformin.

Read the detailed description

Information from laboratory studies and retrospective studies of patients with this disease has shown that the addition of metformin (a commonly used medicine for treating diabetes) to chemotherapy and radiation can improve the rate at which the cancer responds to treatment. Metformin is used frequently in the treatment of patients with diabetes and other illness, but has not yet been used to treat patients with this type of cancer. In this research study, we want to see if using metformin during treatment with chemotherapy and radiation will increase the chance that the cancer will respond to treatment and not return.

Conditions: Head and Neck Squamous Cell Carcinoma
Being tested: Metformin
Keywords: metformin, head and neck cancer
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

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

MetforminDrug
Metformin will be administered orally twice daily during treatment with chemo-radiation for head and neck squamous cell carcinoma. This will occur 7 to 11 days prior to chemotherapy and radiation.

Study groups in NCT02949700
Study group	Role	What they receive
Single arm, treatment	Experimental	Patients in the Phase I trial will be assigned to a single arm, experimental treatment which will test dose escalation for metformin in the context of chemo-radiation, with toxicity as the primary outcome. Patients in the Phase II trial will be assigned to a single arm, experimental treatment consisting of metformin plus chemo-radiation. Receives: Drug: Metformin

What is being measured

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

Phase I - Dose-Limiting Toxicity
Dose limiting toxicities include diarrhea/gastrointestinal disturbance and hypoglycemia requiring dose reduction, and they will be measured for the time frame detailed above. Adverse Events (AE)s will be graded in accordance with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) http://ctep.cancer.gov/ reporting/ctc.html. If not described in the NCI-CTCAE, AEs will be graded according to their severity using the following criteria: grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (life threatening).
Measured: treatment duration plus 30 days following treatment (an average of 13 weeks)
Phase II - Efficacy (Disease Response Rate)
Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) Committee [Eur J Cancer. 2009 Jan; 45(2):228-47]. Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST 1.1 criteria. For the purposes of this study, patients should be reevaluated for response following completion of treatment as per current institutional protocol for this disease site: 1) spiral contrast enhanced computed tomography (CECT) at 10 weeks following completion of treatment or 2) positron emission tomography (PET) at 12 weeks following completion of treatment. Per RECIST v1.1 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Disease response rate is defined as the percentage of patients with OR.
Measured: Treatment duration plus 8-12 weeks following treatment completion (up to 21 weeks total)

Secondary outcomes (2)

Phase II - Progression Free Survival
Measurement of time from date of study registration to date of documented radiographic recurrence/progression or death.
Measured: Date of study registration to recurrence/progression/death or up to 2 years following treatment completion, whichever comes first.
Phase II - Overall Survival
Measurement of time from date of study registration to date of death.
Measured: Date of study registration to death or up to 2 years following treatment completion, whichever comes first.

Timeline

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

26 Jan 20177 Jul 2022

First posted31 Oct 2016 (estimated)
Study start26 Jan 2017
Primary completion28 Jun 2021
Study completion7 Jul 2022

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 Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02949700
Sponsor's protocol ID: H-39773
Status last verified: Jun 2023
First submitted: 27 Oct 2016
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kemnade JO, Florez M, Sabichi A, Zhang J, Jhaveri P, Chen G, Chen A, Miller-Chism C, Shaun B, Hilsenbeck SG, Hernandez DJ, Skinner HD, Sandulache VC. Phase I / II trial of metformin as a chemo-radiosensitizer in a head and neck cancer patient population. Oral Oncol. 2023 Oct;145:106536. doi: 10.1016/j.oraloncology.2023.106536. Epub 2023 Aug 8.
PubMed 37562095

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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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)

All Head and Neck Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT02949700
Acronym / sponsor ID: H-39773
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: metformin, head and neck cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: 26 Jan 2017 (actual)
Primary completion: 28 Jun 2021 (actual)
Study completion: 7 Jul 2022 (actual)
First posted: 31 Oct 2016 (estimated)
Results: Posted 21 Jul 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm, treatment	Experimental	Drug: MetforminPatients in the Phase I trial will be assigned to a single arm, experimental treatment which will test dose escalation for metformin in the context of chemo-radiation, with toxicity as the primary outcome. Patients in the Phase II trial will be assigned to a single arm, experimental treatment consisting of metformin plus chemo-radiation.

Who may qualify

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

Key inclusion criteria (23 listed)

Diagnosis: Patients must have histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx. Patients eligible for inclusion must have stage III-IV SCC of the above sites based on current AJCC clinical and imaging based staging (see Appendix A for staging criteria). For the phase II component, patients should present with: 1) HPV- SCC or 2) HPV+ SCC and a concomitant ≥10pack-year smoking history documented in the clinical record; HPV status will be ascertained using the currently utilized clinical standard of p16 overexpression via immunohistochemistry for all patients. Immunohistochemistry to determine p16 overexpression is only a requirement for oropharyngeal disease.
Disease Status: Only patients with active, measurable disease will be included in the study.
Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Patients treated with chemotherapy (i.e. cisplatin) and/or EBRT for a cancer at a different, non-head and neck site, will be eligible for the trial. Patients previously treated with chemotherapy and/or EBRT for a cancer of the head and neck region, irrespective of histology will not be eligible to participate in the trial.
Myelosuppressive chemotherapy: Must not have received within 4 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor.

Key exclusion criteria (9 listed)

Concomitant Medications: Patients may not be receiving any other investigational agents.
Brain metastases: Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Prior Allergies: History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin.
Patients with diabetes mellitus (DM) will be excluded from the study. Criteria for a diagnosis of diabetes mellitus are as follows: a) known diagnosis of DM, b) active treatment for DM, c) fasting glucose level ≥ 126mg/dl or d) hemoglobin A1c ≥ 6.0% obtained within 30 days prior to registration.
Intercurrent Illness: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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
MetforminMetformin will be administered orally twice daily during treatment with chemo-radiation for head and neck squamous cell carcinoma. This will occur 7 to 11 days prior to chemotherapy and radiation.	Drug	Single arm, treatment

Primary outcome

Phase I - Dose-Limiting Toxicity
Time frame: treatment duration plus 30 days following treatment (an average of 13 weeks)
Dose limiting toxicities include diarrhea/gastrointestinal disturbance and hypoglycemia requiring dose reduction, and they will be measured for the time frame detailed above. Adverse Events (AE)s will be graded in accordance with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) http://ctep.cancer.gov/ reporting/ctc.html. If not described in the NCI-CTCAE, AEs will be graded according to their severity using the following criteria: grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (life threatening).
Phase II - Efficacy (Disease Response Rate)
Time frame: Treatment duration plus 8-12 weeks following treatment completion (up to 21 weeks total)
Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) Committee [Eur J Cancer. 2009 Jan; 45(2):228-47]. Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST 1.1 criteria. For the purposes of this study, patients should be reevaluated for response following completion of treatment as per current institutional protocol for this disease site: 1) spiral contrast enhanced computed tomography (CECT) at 10 weeks following completion of treatment or 2) positron emission tomography (PET) at 12 weeks following completion of treatment. Per RECIST v1.1 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Disease response rate is defined as the percentage of patients with OR.

2 secondary outcomes

Phase II - Progression Free Survival
Time frame: Date of study registration to recurrence/progression/death or up to 2 years following treatment completion, whichever comes first.
Phase II - Overall Survival
Time frame: Date of study registration to death or up to 2 years following treatment completion, whichever comes first.

Results and safety

Results posted to the registry on 21 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm, Treatment: DL1 (Phase I)	9	7
Single Arm, Treatment: DL2	3	2
Single Arm, Treatment: DL-1	0	0
Single Arm, Treatment: DL1 (Phase II)	0	0

Primary outcome: Phase I - Dose-Limiting Toxicity

Time frame: treatment duration plus 30 days following treatment (an average of 13 weeks). Number. Unit: dose-limiting toxicities

Measure	Single Arm, Treatment: DL1 (Phase I) n = 7	Single Arm, Treatment: DL2 n = 2
Value	0	0

Population analysed: Participants were considered for Phase I toxicity (dose-limiting toxicity) evaluation if they were enrolled in the Phase I portion and took 70% or more of the study drug throughout the course of the trial. 9 out of 25 subjects (7 on DL1 (Phase I), 2 on DL2) met this criterion.

Primary outcome: Phase II - Efficacy (Disease Response Rate)

Time frame: Treatment duration plus 8-12 weeks following treatment completion (up to 21 weeks total). Number (95% Confidence Interval). Unit: percentage of participants with response

Measure	Single Arm, Treatment: DL1 (Phase II) n = 7
Value	100.0 (59.0 to 100.0)

Population analysed: Participants were considered for Phase II efficacy (disease response rate) evaluation if they were enrolled in the Phase II portion and took 70% or more of the study drug throughout the course of the trial. 7 out of 25 subjects (7 on DL1 (Phase II)) met this criterion.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The AE collection/reporting period began with the first day of treatment with metformin and was completed at 30 days following treatment completion of each participant. This resulted in a 13 week period of AE collecting/reporting for each participant. All-cause mortality data was collected up to 2 years following treatment completion, as per Outcome Measure 4.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm, Treatment: DL1 (Phase I)	1 of 9 (11.1%)	8 of 9 (88.9%)	4 of 9
Single Arm, Treatment: DL2	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Single Arm, Treatment: DL-1	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Single Arm, Treatment: DL1 (Phase II)	3 of 12 (25%)	12 of 12 (100%)	4 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37562095Kemnade JO, Florez M, Sabichi A, Zhang J, Jhaveri P, Chen G, Chen A, Miller-Chism C, Shaun B, Hilsenbeck SG, Hernandez DJ, Skinner HD, Sandulache VC. Phase I / II trial of metformin as a chemo-radiosensitizer in a head and neck cancer patient population. Oral Oncol. 2023 Oct;145:106536. doi: 10.1016/j.oraloncology.2023.106536. Epub 2023 Aug 8.
Individual participant dataSharing planned: No

Related trials for Head and Neck Squamous Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingPhase 2
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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.

Vlad Sandulache, MD, PhD principal investigator

Baylor College of Medicine

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Metformin in people with Head and Neck Squamous Cell Carcinoma, run by Baylor College of Medicine at 3 sites 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 23 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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 Jul 2022). 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?

Phase I - Dose-Limiting Toxicity (time frame: treatment duration plus 30 days following treatment (an average of 13 weeks)). The study lists 2 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 NCT02949700, 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 29 Jun 2023.