What side effects are associated with this type of intervention?

Common cancer treatments, particularly those involving microtubule inhibitors like Paclitaxel, are associated with several side effects. Paclitaxel can cause peripheral neuropathy, myelosuppression, alopecia, nausea, vomiting, diarrhea, and mucositis. General chemotherapy side effects include fatigue, increased risk of infection due to neutropenia, anemia, thrombocytopenia, and gastrointestinal disturbances. Specific agents may also have unique toxicities, such as nephrotoxicity and ototoxicity with cisplatin, or cardiotoxicity with certain anthracyclines.

What prior FDA approvals exist?

Several FDA-approved treatments for cancer involve microtubule inhibitors like Paclitaxel. For instance, Docetaxel, another microtubule inhibitor, is approved for various cancers including breast cancer, non-small cell lung cancer, and prostate cancer. Additionally, combination therapies involving Paclitaxel and other agents, such as Carboplatin for ovarian cancer and Nab-paclitaxel for pancreatic cancer, have also received FDA approval. These treatments highlight the efficacy of microtubule inhibitors in cancer therapy, often in combination with other chemotherapeutic agents to enhance treatment outcomes.

What other types of research exist?

Promising novel alternatives to NRC-2694-A in combination with Paclitaxel for cancer patients include: 1) ELR510444, a novel microtubule disruptor with potential antivascular effects and in vivo antitumor efficacy. 2) Pembrolizumab (an anti-PD-1 therapy) in combination with chemotherapy, which has shown efficacy in various cancers including non-small cell lung cancer. 3) Atezolizumab (an anti-PD-L1 therapy) combined with chemotherapy, which has been effective in non-small cell lung cancer. 4) PARP inhibitors for patients with homologous recombination repair deficiency, offering a targeted approach for specific genetic profiles.

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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

Must not have

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

Unable to come for study visits per schedule

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through approximately up to 26 weeks

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

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.

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.

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.

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 below

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

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My cancer has grown or spread as shown in my latest scans.

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My cancer in the head or neck area cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

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I cannot attend the scheduled study visits.

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I have cancer in my nasopharynx or salivary glands.

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I am pregnant.

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I am breastfeeding, planning to become pregnant, or plan to father a child during the study.

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I have taken drugs targeting EGFR for my recurring or spreading cancer.

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I've had treatments after pembrolizumab/nivolumab didn't work for me.

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My heart's electrical cycle is longer than normal.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately up to 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assessing safety through ECOG (Eastern Cooperative Oncology Group)

Clinical benefit response

Duration of response

+6 more

Other study objectives

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

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like Paclitaxel work by inhibiting microtubule function, which disrupts cell division and leads to cancer cell death. Targeted therapies, such as PARP inhibitors for BRCA-mutated cancers, interfere with specific molecular targets involved in cancer growth and survival. Immunotherapies, including PD-1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells. Understanding these mechanisms is crucial for cancer patients as it helps tailor treatments to their specific cancer type, potentially improving efficacy and reducing side effects.

The evolving role of cytotoxic chemotherapy in the management of patients with metastatic prostate cancer.