NRC-2694-A + Paclitaxel for Head and Neck Cancer

Not currently recruiting at 12 trial locations

Overseen By Praveen Myneni, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NATCO Pharma Ltd.

Must not be taking: EGFR inhibitors, Taxanes

Disqualifiers: Cardiac, Hepatic, Endocrine, Pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for head and neck cancer that has returned or spread after initial therapy. The study examines the effectiveness of NRC-2694-A, an experimental drug, when combined with paclitaxel, a standard chemotherapy drug. It aims to determine if this combination can improve outcomes for patients whose cancer has progressed after certain immune therapies. Suitable candidates for this trial include individuals with recurrent or metastatic head and neck cancer who have previously tried immune therapy and experienced cancer progression. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have stopped any ICI therapy or investigational therapy at least two weeks before starting the trial and recovered from any related side effects.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of NRC-2694-A and paclitaxel has been studied for treating head and neck cancer. Paclitaxel, also known as Taxol, is generally considered safe, but it can cause side effects. The most common side effect is neutropenia, a condition characterized by a low count of white blood cells, which are crucial for fighting infections.

NRC-2694-A remains under study, so its safety profile is not yet fully understood. This trial is in Phase 2, indicating that earlier studies have shown it to be somewhat safe in humans. Researchers continue to assess how well people can tolerate it and what side effects it might cause.

Close medical supervision is important for participants during a trial to manage any side effects that might occur. Prospective participants should discuss the potential risks and benefits with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Unlike the standard treatments for head and neck cancer, which often involve surgery, radiation, and chemotherapy, NRC-2694-A is unique because it is an oral medication that works in combination with paclitaxel, a well-known chemotherapy drug. This combination targets cancer cells more precisely, potentially reducing side effects associated with traditional treatments. Researchers are excited about NRC-2694-A because it offers a new mechanism of action that may enhance the effectiveness of paclitaxel, possibly leading to better outcomes for patients with fewer cycles of treatment.

What evidence suggests that this treatment might be an effective treatment for head and neck cancer?

Research has shown that combining NRC-2694-A with paclitaxel, which participants in this trial will receive, may help treat head and neck cancer, particularly in patients whose cancer worsened after other treatments. Paclitaxel already works well for this type of cancer, making this new combination promising. Early results suggest that this combination could outperform current treatments, aiming to help 50% of patients compared to the usual 30%. This indicates a good chance of shrinking tumors or slowing cancer progression. While more research is needed, the initial findings are encouraging. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

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.

Exclusion Criteria

I've had paclitaxel or docetaxel for head and neck cancer that came back or spread.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• NRC-2694-A
• Paclitaxel

Trial Overview 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.

How Is the Trial Designed?

Group I: NRC-2694-A In Combination with paclitaxel Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

NATCO Pharma Ltd.

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Paclitaxel shows promising activity against squamous cell carcinoma of the head and neck, with preliminary results from a phase II trial indicating two complete and seven partial responses among 19 patients.

While paclitaxel is effective, it is associated with significant toxicities, including grades 3 and 4 neutropenia and grades 1 and 2 neuropathy, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of paclitaxel (Taxol) in squamous cell carcinoma of the head and neck. Forastiere, AA.[2015]

In a study of 54 patients with locally advanced nasopharyngeal carcinoma, the combination of weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy resulted in an 85% complete response rate and a 3-year overall survival rate of 76%.

The treatment was well-tolerated, with no severe acute toxicities reported, indicating that this regimen is both effective and safe for patients with this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma. Hu, W., Ding, W., Yang, H., et al.[2022]

In a phase II trial involving 30 patients with recurrent head and neck cancer, high-dose paclitaxel (250 mg/m2) demonstrated a 40% response rate, indicating its potential effectiveness as a treatment option.

The main side effects observed were neutropenia, peripheral neuropathy, and arthralgias/myalgias, which are consistent with previous studies, suggesting that while paclitaxel is promising, careful monitoring for these toxicities is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol) for the treatment of head and neck cancer. Forastiere, AA.[2015]

In a study of 46 patients with recurrent or metastatic squamous cell carcinoma of the head and neck, the combination of weekly paclitaxel and cetuximab showed a promising overall response rate of 54%, with 22% achieving complete responses.

The treatment was well tolerated, with a disease control rate of 80% and median overall survival of 8.1 months, making it a potential option for patients who cannot receive platinum-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of the combination of cetuximab and weekly paclitaxel in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of head and neck. Hitt, R., Irigoyen, A., Cortes-Funes, H., et al.[2022]

Paclitaxel and docetaxel have shown promise in treating squamous cell carcinoma of the head and neck, especially when combined with other therapies like radiotherapy, demonstrating feasibility and effectiveness without excessive toxicity in patients.

Current research indicates that low-dose fractionated radiotherapy combined with taxanes is yielding positive results, but further phase III studies are necessary to establish these combinations as superior to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taxanes in the treatment of head and neck cancer. Schrijvers, D., Vermorken, JB.[2019]

Weekly paclitaxel treatment in 74 patients with recurrent or metastatic head and neck cancer showed a 29% overall response rate, indicating promising efficacy in this challenging condition.

The treatment was associated with manageable side effects, with the most common severe adverse events being leukopenia and neutropenia, suggesting that while effective, careful monitoring of blood counts is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weekly paclitaxel in patients with recurrent or metastatic head and neck cancer. Tahara, M., Minami, H., Hasegawa, Y., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05283226

Study to Evaluate the Safety and Efficacy of Oral NRC ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05283226/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

Study to Evaluate the Safety and Efficacy of Oral NRC ... 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 ...

3. withpower.com withpower.com/trial/phase-2-squamous-cell-carcinoma-of-head-and-neck-2-2022-c4bd6

NRC-2694-A + Paclitaxel for Head and Neck Cancer Additionally, paclitaxel has been tested in combination with other treatments, showing promise in managing squamous cell carcinoma of the head and neck. Show ...

4. researchgate.net researchgate.net/publication/371297230_Oral_NRC-2694-A_in_combination_with_paclitaxel_as_therapy_for_recurrent_andor_metastatic_head_and_neck_squamous_cell_carcinoma_RM-HNSCC_that_progressed_on_or_after_an_immune_checkpoint_inhibitor_ICI_A

Oral NRC-2694-A in combination with paclitaxel as therapy ... ... head and neck cancer gives similar tumor control but with less toxicity for bioradiotherapy. ... We designed a phase 2 trial to evaluate the ...

5. synapse.patsnap.com synapse.patsnap.com/drug/b4a876d34d354964a61cfecb76d61266

NRC-2694 - Drug Targets, Indications, Patents A Phase II Clinical Study to evaluate the efficacy and safety of NRC-2694-A in patients with recurrent Head and Neck Squamous Cell Carcinoma. CTRI/2014/01 ...

6. asco.org asco.org/abstracts-presentations/ABSTRACT409790

Results from two phase II studies of SI-B001, an EGFR× ... SI-B001 plus paclitaxel demonstrated potential improvements in ORR and DCR compared with SI-B001 monotherapy in recurrent and metastatic HNSCC.