Head and Neck CancerPhase 1/2NCT03024489
Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma
A Phase 1/2 study testing Palbociclib, Cetuximab and Intensity Modulated Radiation Therapy in people with Head and Neck Cancer and Locally Advanced, run by Mahidol University at 1 site in Thailand.
Trial summary
Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle. Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Locally Advanced
- What is being tested?
- Palbociclib, Cetuximab and Intensity Modulated Radiation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- 19 Jul 2017to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Locally advanced histology or cytology proven squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx.
- Locally advanced SCCCH patients who would be considered for concurrent cetuximab and IMRT as a definitive treatment.
- Age ≥ 18 yeas old.
- Available tissue to determine HPV status and the other biomarkers of interest.
- ECOG status ≤ 1.
- Adequate bone marrow, liver, and renal functions, defined as:
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- Platelet count ≥150 x 109/L, Absolute Neutrophile Count (ANC) ≥1.5 x 109/L, Hgb ≥9 gm/dL
- ALT and AST ≤ 1.5 upper limit normal (ULN); serum total bilirubin ≤ ULN
- Serum creatinine ≤ 1.5 x ULN, or calculated or measured creatinine clearance (by Cockcroft-Gault Equation) ≥ 50 mL/min
- Magnesium ≥ the lower limit of normal
- Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug.
- Male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 6 months after last investigational drug dose received.
- Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- Potential subjects who meet ANY of the following exclusion criteria are not eligible for enrollment into this study:
- SCCHN patients with distance metastasis.
- Major surgery < 4 weeks or minor surgery < 2 weeks prior to the first day of study treatment.
- Patients with previous chemotherapy for cancer treatment and radiation to the head and neck areas.
- Patients who were previously treated with any CDK4/6 inhibitors or cetuximab.
- SCCHN with expressed p16 by IHC (only in expansion cohort).
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- Active cardiac disease described as:
- Left ventricular ejection fraction (LVEF) < 50% by Multiple Grated acquisition (MUGA) scan or echocardiogram (ECHO).
- QTc > 480 msec on screening EKG (using the QTcF formula).
- Congenital long QT syndrome
- Myocardial infarction or active uncontrolled angina pectoris within the last 6 months prior to the first day of study treatment
- Uncontrolled significant cardiac arrhythmias except for benign premature ventricular contractions (PVC) and premature atrial contractions (PAC).
- Symptomatic pericarditis
- History of cardiomyopathy
- Weight loss more than 10% from baseline body weight before illness.
- Active clinically serious infections or other serious uncontrolled medical conditions.
- Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results.
- Unable to swallow an intact palbociclib tablet.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of palbociclib.
- Known HBV, HCV, and/or HIV infection.
- Patients who are currently treated with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
- Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Fruits include the CYP3A inhibitors Seville oranges, grapefruit, pomelos, or exotic citrus fruits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Dose Escalation Study of the CDK4/6 Inhibitor, Palbociclib in Combination With Cetuximab and Intensity Modulated Radiation Therapy (IMRT) for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle. Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many cancers. Several mechanisms have been described: (i) Amplification or overexpression of cyclin D1, (ii) Amplification of CDK4, (iii) Activating mutation of CDK4, and (iv) Loss of the CDK4 inhibitor, p16 (CDKN2A). Human Papilloma Virus (HPV) plays a major role in squamous cell carcinoma of head and neck (SCCHN) carcinogenesis. It induces many alterations in the CDK4-Cyclin D-Rb and apoptotic pathways such as up-regulation of p16, loss of Rb and p53 functions. A novel therapy for HPV-negative SCCHN is clearly an unmet medical need.
Palbociclib (PD 0332991) is an orally active, highly selective inhibitor of the CDK4/6 with ability to block Rb phosphorylation in the low nanomolar range. The most advanced development is in a treatment of metastatic breast cancer. In addition, palbociclib showed a radiosensitization property. Since combination of cetuximab and radiation improved PFS and overall survival (OS) in locally advanced SCCHN when compared with radiation alone, these provide a strong rationale to evaluate a combination of palbociclib, cetuximab, and radiation for locally advanced SCCHN. Because many genetic alterations in SCCHN significantly involve in the CDK4-cyclin D-Rb pathway, predictive biomarker(s) of palbociclib in this combination will be explored.
Thus, the investigators propose a non-randomized, dose escalation, phase I study designed to determine the maximum tolerated dose (MTD) and toxicity of palbociclib, cetuximab, and IMRT for locally advanced SCCHN.
Read the detailed description
The enrollment of an initial patient cohort of 3 or 6 patients will follow the traditional "3 + 3" dose escalation scheme (see table below). The patients will be treated with palbociclib, cetuximab, and IMRT at starting at Dose Level (DL) 1. Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of the initial cohort. If <33% patients treated at Dose Level 1 experience DLT (see definition below) by the end of treatment (56 days), then next cohort of 3 patients will be enrolled and treated at Dose Level 2. If 2 treatment-related DLTs are observed at Dose Level 1, patients will be accrued to Dose Level -1. The MTD is defined as the maximum dose level at which ≤1/6 patients have DLTs.
At the MTD or RP2D, we will accrue up to 15 locally advanced unresectable p16-negative SCCHN patients to allow for definitive evaluation of tolerability, correlative endpoints and preliminary efficacy. CT/PET scan will be performed at 3 months after the last dose of radiation to evaluate residual disease. Patients with residual disease will be considered for salvage surgery following standard of care.
- IMRT will be administered 5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions.
- Cetuximab will be administered 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks.
- Palbociclib will be administered orally daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
- Conditions
- Head and Neck Cancer, Locally Advanced
- Being tested
- Palbociclib, Cetuximab, Intensity Modulated Radiation Therapy
- Keywords
- Phase I/II
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called PD-0332991
Dose Level -1: 100 mg oral every other day 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
PalbociclibDrug
Also called PD-0332991
Dose Level 1: 75 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
PalbociclibDrug
Also called PD-0332991
Dose Level 2: 100 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
PalbociclibDrug
Also called PD-0332991
Dose Level 3: 125 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
CetuximabDrug
Also called Erbitux
All dose levels: 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks.
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib-Cetuximab-IMRT | Experimental | * IMRT will be administered 5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions.
* Cetuximab will be administered 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks.
* Palbociclib will be administered orally daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49) on 3 dose levels and the MTD. Receives: Drug: Palbociclib; Drug: Cetuximab; Radiation: Intensity Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D)
To describe the dose-limiting toxicities and identify the recommended phase I dose (RP2D) of the combination of palbociclib, cetuximab, and IMRT for locally advanced SCCHN.
Recommended Phase II Dose (RP2D) is a maximum tolerated dose (MTD) or the highest dose level when MTD is not reached.
Toxicity will be assessed using the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. A DLT is defined by the occurrence of any of the following toxicities related to palbociclib and the combination within 8 weeks of treatment duration.
Measured: From baseline to the completion of radiotherapy (up to 8 weeks)
Secondary outcomes (3)
Evaluate preliminary efficacy of the combination
Objective response rate (ORR) by the RECIST criteria version 1.1 and PET/CT scan response at 3 months after completion of treatment will be used to evaluate preliminary efficacy of this combination.
Measured: From baseline to 3 months after completion of radiotherapy (up to 5 months)
Evaluate safety profile of the combination of palbociclib, cetuximab and IMRT
All toxicities, including acute and chronic toxicities will be evaluated by the CTCAE V.4.
Measured: From baseline to 1 year after completion of radiotherapy (up to 14 months)
Evaluate anti-tumor activity of the combination depending on Rb status
Objective response rate (ORR) by the RECIST criteria version 1.1 and PET/CT scan response at 3 months after completion of treatment will be used to evaluate preliminary efficacy of this combination. Rb status will be correlated with the ORR.
Measured: From baseline to 3 months after completion of radiotherapy (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start19 Jul 2017
- Primary completion11 Mar 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuttapong Ngamphaiboon, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024489
- Sponsor's protocol ID
- RA2016001
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2016
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ngamphaiboon N, Pattaranutaporn P, Lukerak S, Siripoon T, Jinawath A, Arsa L, Shantavasinkul PC, Taonam N, Trachu N, Jinawath N, Kositwattanarerk A, Sananmuang T, Jiarpinitnun C. A Phase I Study of the CDK4/6 Inhibitor Palbociclib in Combination with Cetuximab and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2024 Jan 17;30(2):294-303. doi: 10.1158/1078-0432.CCR-23-2303.
PubMed 37982827
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose Escalation Study of the CDK4/6 Inhibitor, Palbociclib in Combination With Cetuximab and Intensity Modulated Radiation Therapy (IMRT) for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT03024489
- Acronym / sponsor ID
- RA2016001
- Conditions
- Head and Neck Cancer, Locally Advanced
- Keywords
- Phase I/II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle. Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many cancers. Several mechanisms have been described: (i) Amplification or overexpression of cyclin D1, (ii) Amplification of CDK4, (iii) Activating mutation of CDK4, and (iv) Loss of the CDK4 inhibitor, p16 (CDKN2A). Human Papilloma Virus (HPV) plays a major role in squamous cell carcinoma of head and neck (SCCHN) carcinogenesis. It induces many alterations in the CDK4-Cyclin D-Rb and apoptotic pathways such as up-regulation of p16, loss of Rb and p53 functions. A novel therapy for HPV-negative SCCHN is clearly an unmet medical need.
Palbociclib (PD 0332991) is an orally active, highly selective inhibitor of the CDK4/6 with ability to block Rb phosphorylation in the low nanomolar range. The most advanced development is in a treatment of metastatic breast cancer. In addition, palbociclib showed a radiosensitization property. Since combination of cetuximab and radiation improved PFS and overall survival (OS) in locally advanced SCCHN when compared with radiation alone, these provide a strong rationale to evaluate a combination of palbociclib, cetuximab, and radiation for locally advanced SCCHN. Because many genetic alterations in SCCHN significantly involve in the CDK4-cyclin D-Rb pathway, predictive biomarker(s) of palbociclib in this combination will be explored.
Thus, the investigators propose a non-randomized, dose escalation, phase I study designed to determine the maximum tolerated dose (MTD) and toxicity of palbociclib, cetuximab, and IMRT for locally advanced SCCHN.
Detailed description
The enrollment of an initial patient cohort of 3 or 6 patients will follow the traditional "3 + 3" dose escalation scheme (see table below). The patients will be treated with palbociclib, cetuximab, and IMRT at starting at Dose Level (DL) 1. Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of the initial cohort. If <33% patients treated at Dose Level 1 experience DLT (see definition below) by the end of treatment (56 days), then next cohort of 3 patients will be enrolled and treated at Dose Level 2. If 2 treatment-related DLTs are observed at Dose Level 1, patients will be accrued to Dose Level -1. The MTD is defined as the maximum dose level at which ≤1/6 patients have DLTs.
At the MTD or RP2D, we will accrue up to 15 locally advanced unresectable p16-negative SCCHN patients to allow for definitive evaluation of tolerability, correlative endpoints and preliminary efficacy. CT/PET scan will be performed at 3 months after the last dose of radiation to evaluate residual disease. Patients with residual disease will be considered for salvage surgery following standard of care.
- IMRT will be administered 5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions.
- Cetuximab will be administered 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks.
- Palbociclib will be administered orally daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib-Cetuximab-IMRT | Experimental | Drug: Palbociclib, Drug: Cetuximab, Radiation: Intensity Modulated Radiation Therapy* IMRT will be administered 5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions. * Cetuximab will be administered 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks. * Palbociclib will be administered orally daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49) on 3 dose levels and the MTD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Locally advanced histology or cytology proven squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx.
- Locally advanced SCCCH patients who would be considered for concurrent cetuximab and IMRT as a definitive treatment.
- Age ≥ 18 yeas old.
- Available tissue to determine HPV status and the other biomarkers of interest.
- ECOG status ≤ 1.
Key exclusion criteria (22 listed)
- Potential subjects who meet ANY of the following exclusion criteria are not eligible for enrollment into this study:
- SCCHN patients with distance metastasis.
- Major surgery < 4 weeks or minor surgery < 2 weeks prior to the first day of study treatment.
- Patients with previous chemotherapy for cancer treatment and radiation to the head and neck areas.
- Patients who were previously treated with any CDK4/6 inhibitors or cetuximab.
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 |
|---|---|---|
| PalbociclibAlso: PD-0332991Dose Level -1: 100 mg oral every other day 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49). | Drug | Palbociclib-Cetuximab-IMRT |
| PalbociclibAlso: PD-0332991Dose Level 1: 75 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49). | Drug | Palbociclib-Cetuximab-IMRT |
| PalbociclibAlso: PD-0332991Dose Level 2: 100 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49). | Drug | Palbociclib-Cetuximab-IMRT |
| PalbociclibAlso: PD-0332991Dose Level 3: 125 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49). | Drug | Palbociclib-Cetuximab-IMRT |
| CetuximabAlso: ErbituxAll dose levels: 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks. | Drug | Palbociclib-Cetuximab-IMRT |
| Intensity Modulated Radiation TherapyAlso: IMRT5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions. | Radiation | Palbociclib-Cetuximab-IMRT |
Primary outcome
Determination of dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D)
Time frame: From baseline to the completion of radiotherapy (up to 8 weeks)
To describe the dose-limiting toxicities and identify the recommended phase I dose (RP2D) of the combination of palbociclib, cetuximab, and IMRT for locally advanced SCCHN. Recommended Phase II Dose (RP2D) is a maximum tolerated dose (MTD) or the highest dose level when MTD is not reached. Toxicity will be assessed using the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. A DLT is defined by the occurrence of any of the following toxicities related to palbociclib and the combination within 8 weeks of treatment duration.
3 secondary outcomes
Evaluate preliminary efficacy of the combination
Time frame: From baseline to 3 months after completion of radiotherapy (up to 5 months)
Evaluate safety profile of the combination of palbociclib, cetuximab and IMRT
Time frame: From baseline to 1 year after completion of radiotherapy (up to 14 months)
Evaluate anti-tumor activity of the combination depending on Rb status
Time frame: From baseline to 3 months after completion of radiotherapy (up to 5 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 37982827Ngamphaiboon N, Pattaranutaporn P, Lukerak S, Siripoon T, Jinawath A, Arsa L, Shantavasinkul PC, Taonam N, Trachu N, Jinawath N, Kositwattanarerk A, Sananmuang T, Jiarpinitnun C. A Phase I Study of the CDK4/6 Inhibitor Palbociclib in Combination with Cetuximab and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma. Clin Cancer Res. 2024 Jan 17;30(2):294-303. doi: 10.1158/1078-0432.CCR-23-2303.
- Individual participant dataSharing planned: Undecided
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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.
Nuttapong Ngamphaiboon, MD principal investigator
Ramathibodi Hospital
1 site 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 Palbociclib, Cetuximab and Intensity Modulated Radiation Therapy in people with Head and Neck Cancer and Locally Advanced, run by Mahidol University at 1 site in Thailand.
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 13 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Thailand. 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?
Results are not available in the source record.
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?
Determination of dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D) (time frame: From baseline to the completion of radiotherapy (up to 8 weeks)). 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 NCT03024489, 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 15 Mar 2024.