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NRC-2694-A + Paclitaxel for Head and Neck Cancer
Phase 2
Recruiting
Research Sponsored by NATCO Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has ECOG performance status score of ≤2
Has documented radiographical progressive disease assessed by the principal investigator per RECIST v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately up to 26 weeks
Awards & highlights
Study Summary
This trial will test the effects of a new drug, NRC-2694-A, on patients with head and neck cancer that has progressed after immunotherapy. The trial will enroll approximately 46 patients. The target response rate is 50%.
Who is the study for?
Adults with certain types of head and neck cancer that has returned or spread, who have previously tried specific immune therapies without success. Participants must be in good physical condition with well-functioning organs, not pregnant or breastfeeding, willing to use contraception, and free from HIV/HBV/HCV infections.Check my eligibility
What is being tested?
The trial is testing a new oral medication called NRC-2694-A combined with the chemotherapy drug Paclitaxel. It's an open-label study where all patients receive the same treatment to see if it can improve their response compared to past treatments.See study design
What are the potential side effects?
Possible side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems. The new drug may also have unique side effects which will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer has grown or spread as shown in my latest scans.
Select...
My cancer in the head or neck area cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through approximately up to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately up to 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if NRC-2694-A administered orally in combination with paclitaxel demonstrates objective response in patients with R/M HNSCC, who have had radiological progression on or after treatment with ICI therapies like pembrolizumab or nivolumab
Secondary outcome measures
Assessing safety through ECOG (Eastern Cooperative Oncology Group)
Clinical benefit response
Duration of response
+16 moreOther outcome measures
To determine the association between NRC-2694-A activity and biomarkers in blood samples using Epidermal growth factor receptor status in EGFR (epidermal growth factor receptor) gene
To determine the association between NRC-2694-A activity and biomarkers in blood samples using downstream signaling in EGFR gene
To determine the association between NRC-2694-A activity and biomarkers in blood samples using mutations in EGFR gene
Trial Design
1Treatment groups
Experimental Treatment
Group I: NRC-2694-A In Combination with paclitaxelExperimental Treatment2 Interventions
Patients will receive NRC-2694-A 300 mg orally once daily and paclitaxel 175 mg/m² IV infusion over approximately 3 hours once in 21 days for 6 cycles or more.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
NATCO Pharma Ltd.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I've had paclitaxel or docetaxel for head and neck cancer that came back or spread.My cancer has grown or spread as shown in my latest scans.My blood, kidney, and liver tests meet the required levels for the study.I haven't needed IV antibiotics for an infection in the last week.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I do not have uncontrolled health issues that would interfere with cancer treatment.I have received cetuximab for my recurring or spreading cancer.I have not had major surgery in the last 4 weeks.I am a woman who can have children and have a negative pregnancy test.My cancer got worse after ICI therapy like pembrolizumab or nivolumab, but I've recovered from any side effects.I have HIV, HBV, or HCV but it's under control or cured.I cannot attend the scheduled study visits.My brain cancer is under control and I'm on a low dose of steroids or none.I have cancer in my nasopharynx or salivary glands.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).I am pregnant.I am breastfeeding, planning to become pregnant, or plan to father a child during the study.I have taken drugs targeting EGFR for my recurring or spreading cancer.I've had treatments after pembrolizumab/nivolumab didn't work for me.My heart's electrical cycle is longer than normal.My cancer in the head or neck area cannot be removed by surgery.I stopped my immune therapy 4 weeks ago and have recovered from its side effects.
Research Study Groups:
This trial has the following groups:- Group 1: NRC-2694-A In Combination with paclitaxel
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants enrolled in this experiment?
"To meet the requirements of this clinical trial, 46 qualified patients must take part. Those looking to join can do so at Washington University - Siteman Cancer Center in Saint Louis, Missouri or Norton Cancer Institute - Downtown Louisville, Kentucky."
Answered by AI
Has the FDA sanctioned the concurrent administration of NRC-2694-A and paclitaxel?
"As this is a Phase 2 trial, there are indications of safety but not efficacy. Our team at Power have rated the medication NRC-2694-A In Combination with paclitaxel as a score of 2 on their 1 to 3 scale."
Answered by AI
Is this research taking on additional participants presently?
"Affirmative. According to clinicaltrials.gov, this research study is currently searching for recruits and was initially posted on September 30th 2022 before being revised on November 23rd 2022. A total of 46 participants are required for the trial across 3 medical centres."
Answered by AI
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