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Tests treatment safety and results for Carcinoma
Official title Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
ClinicalTrials.gov ID: NCT05283226
What this study is testing
What is NRC-2694-A?
NRC-2694-A is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Is willing and capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply...
- Is male or female aged 18 years or older at the time of consent.
- Has histologically confirmed unresectable R/M HNSCC (oral cavity, oropharynx, hypopharynx, and larynx).
- Has documented progressive disease assessed by the principal investigator according to RECIST v1.1.
- Has a measurable lesion per RECIST v1.1.
You likely can't join if
- Has cardiac, hepatic, endocrine, pulmonary, or autoimmune disease, interstitial lung disease, renal or psychiatric disorders, not controlled with...
- Has Cirrhosis of liver at a level of Child-Pugh B (or worse).
- Has uncontrolled brain metastases. Patients are allowed if brain metastasis has been previously treated with surgery, whole brain irradiation, and/or...
- Has baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>480 milliseconds [CTCAE Grade 1] using Fredericia's QT...
- Has a history of additional risk factors for Torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- Has had prior cetuximab therapy for recurrent or metastatic disease. Note that cetuximab used concomitantly with radiotherapy or as an induction...
See the full eligibility criteria
- Is willing and capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
- Is male or female aged 18 years or older at the time of consent.
- Has histologically confirmed unresectable R/M HNSCC (oral cavity, oropharynx, hypopharynx, and larynx).
- Has documented progressive disease assessed by the principal investigator according to RECIST v1.1.
- Has a measurable lesion per RECIST v1.1.
- Has ECOG performance status score of ≤2.
- Must have progressed during or after receiving ICI therapy, such as pembrolizumab or nivolumab. Patients with prior immune-mediated reactions due to ICI therapies (eg, pembrolizumab or nivolumab) and who had recovered...
- Female patients of childbearing potential should have a negative urine test before enrollment. If the urine pregnancy test is positive or gives equivocal results, a serum pregnancy will be required for confirmation.
- Patients of reproductive age must use acceptable methods of contraception throughout the study period and for 30 days following the last dose of investigational product (see protocol for further guidance).
- During screening and at subsequent visits, the investigator should ensure adequate bone marrow reserve (neutrophil count ≥1500/mm3, platelet count ≥100,000/mm3, and hemoglobin level 8.0 g/dL), renal function (creatinine...
- Must have completed a duration of at least two weeks after stopping ICI therapy/investigational therapy/salvage therapy and must have recovered to grade ≤1 from all toxicities due to such therapies.
- Has cardiac, hepatic, endocrine, pulmonary, or autoimmune disease, interstitial lung disease, renal or psychiatric disorders, not controlled with therapy corresponding to the illness or a condition that contraindicates...
- Has Cirrhosis of liver at a level of Child-Pugh B (or worse).
- Has uncontrolled brain metastases. Patients are allowed if brain metastasis has been previously treated with surgery, whole brain irradiation, and/or stereotactic radiosurgery and are considered controlled (controlled...
- Has baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>480 milliseconds [CTCAE Grade 1] using Fredericia's QT correction formula).
- Has a history of additional risk factors for Torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- Has had prior cetuximab therapy for recurrent or metastatic disease. Note that cetuximab used concomitantly with radiotherapy or as an induction therapy is acceptable
- Has received any other EGFR-targeted therapies for recurrent or metastatic disease.
- Currently participating in any clinical trial or receiving investigational therapy on expanded access or compassionate basis.
- Has nasopharyngeal carcinomas or salivary gland cancers.
- Female patient who tested positive for pregnancy.
- Female patient who is breastfeeding or planning to become pregnant, or male patient planning to father a child within the duration of the study.
- Has tested positive for HIV, HBsAg, HCV antibody, or HCV RNA at screening. However, patients who test positive for HCV antibody, but negative for HCV RNA, will be allowed. In addition, patients with controlled HIV...
- Has active infection requiring intravenous anti-infective therapy within 7 days prior to Day 1 Cycle 1 or is febrile due to infection.
- Has had major surgery within 4 weeks prior to screening.
- Administered a live attenuated vaccine within 4 weeks prior to Day 1 Cycle 1 or anticipation that such a live attenuated vaccine will be required during the study.
- Has known or suspected hypersensitivity to any components of the formulation used for this investigational product.
- Has concurrent disease or any clinically significant abnormality following the investigator's review of the screening physical examination findings, 12-lead ECG results, and clinical laboratory tests, which in the...
- Unable to come for study visits per schedule.
- Has current drug or alcohol abuse.
- Has received prior treatment with paclitaxel or docetaxel or any other drugs with taxane like mode of action for recurrent or metastatic or recurrent HNSCC. However, prior paclitaxel or docetaxel or any other drugs with...
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- Los Angeles, California, United States
- Boca Raton, Florida, United States
- Miami, Florida, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- Easton, Pennsylvania, United States
- Madison, Wisconsin, United States
- Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- Hyderabad, Telangana, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States; Los Angeles, California, United States; Boca Raton, Florida, United States; Miami, Florida, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.