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

Recruiting at 10 trial locations

Overseen By Praveen Myneni, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: NATCO Pharma Ltd.

Must not be taking: EGFR inhibitors, Taxanes

Disqualifiers: Cardiac, Hepatic, Endocrine, Pulmonary, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, NRC-2694-A, taken with paclitaxel, for patients with head and neck cancer that has come back or spread and did not respond to previous treatments. The new drug aims to block proteins that help cancer grow, while paclitaxel helps kill the cancer cells. Paclitaxel is a well-established drug known for its effectiveness in treating various cancers, including head and neck cancer. This combination could offer a new treatment option for these patients.

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.

What data supports the effectiveness of the drug NRC-2694-A + Paclitaxel for head and neck cancer?

Research shows that paclitaxel, a component of the treatment, has shown activity against head and neck cancer, with some patients experiencing complete or partial responses. Additionally, paclitaxel has been tested in combination with other treatments, showing promise in managing squamous cell carcinoma of the head and neck. ^{1 2 3 4 5}

Is the combination of NRC-2694-A and Paclitaxel safe for treating head and neck cancer?

Paclitaxel, also known as Taxol, has been studied for head and neck cancer and is generally considered safe, but it can cause side effects like neutropenia (low white blood cell count), neuropathy (nerve damage), and muscle/joint pain. These side effects were observed in trials where paclitaxel was used alone or in combination with other treatments. ^{1 3 4 5 6}

How is the drug NRC-2694-A + Paclitaxel different from other treatments for head and neck cancer?

The combination of NRC-2694-A with Paclitaxel is unique because it involves a novel agent (NRC-2694-A) paired with Paclitaxel, which has shown promising activity in head and neck cancer by promoting microtubule assembly, potentially offering a new approach to improve response rates and survival compared to traditional chemotherapy options. ^{2 3 4 5 6}

Eligibility Criteria

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 am 18 years old or older.

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.

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.

Trial Timeline

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

Treatment Details

Interventions

• NRC-2694-A (Other)
• Paclitaxel (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Weekly paclitaxel in patients with recurrent or metastatic head and neck cancer. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Taxanes in the treatment of head and neck cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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