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Squamous Cell Carcinoma of the Oral CavityEarly Phase 1NCT03459729

Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer

A Early Phase 1 study testing Antitumor B in people with Squamous Cell Carcinoma of the Oral Cavity, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Antitumor B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
24 Aug 2021to 16 Feb 2022
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of oral cavity squamous cell cancer.
  • Patient can start study agent administration but histological confirmation of squamous cell cancer (SCC) of the oral cavity (or histologic variants of SCC) by the pathologist must happen within 7 days of registration in order to continue study agent administration.
  • Clinical stage II-IVA (as defined by the American Joint Committee on Cancer, 8th Edition [see Amin, 2017]) and amenable to surgical resection
  • New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of 6 months following previous definite surgery
  • History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration
  • Study agent administration should start within 7 days of registration
Show all 35Show fewer
  • Patient must receive administration of study agent for a minimum of 7 days
  • Zubrod Score/Eastern Cooperative Oncology Group (ECOG) Performance status < 2.
  • Age ≥ 18 years.
  • Complete Blood Count (CBC)/differential obtained within 14 calendar days prior to registration, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3;
  • Platelets ≥ 100,000 cells/mm^3;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
  • Adequate renal and hepatic function within 14 calendar days prior to registration, defined as follows:
  • o Serum creatinine < 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
  • Total bilirubin < 2 x the institutional upper limit of normal (ULN) within 14 calendar days prior to registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional ULN within 14 calendar days prior to registration
  • Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to registration, with the following required parameters:
  • Magnesium: > 0.9 mg/dl or < 3 mg/dl;
  • Calcium: > 7 mg/dl or < 12.5 mg/dl;
  • Glucose: > 40 mg/dl or < 250 mg/dl;
  • Potassium: > 3 mmol/L or < 6 mmol/L;
  • Sodium: > 130 mmol/L or < 155 mmol/L.
  • Female patients must meet one of the following:
  • Postmenopausal for at least one year before the screening visit, or
  • Surgically sterile (e.g., undergone a hysterectomy or bilateral oophorectomy), or
  • If the subject is of childbearing potential (defined as not satisfying either of the above two criteria), agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 90 days after the last dose of study agent, AND
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.)
  • Male patients, even if surgically sterilized (e.g., status post vasectomy), must agree to one of the following:
  • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
  • Must also adhere to the guidelines of any study-specific pregnancy prevention program, if applicable, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Patients must be deemed able to comply with the study plan.
  • Gastric tube study agent administration is permissible.
  • Patients must provide study-specific informed consent prior to study entry.

Who cannot join

  • History of active liver disease
  • Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
  • Concurrent use of any medicinal botanical, natural, or other herbal compound/s that the study PI believes could potentially impact the results/objectives of this study
  • Planned subtotal or debulking surgery, as determined by enrolling physician determination, is not permissible.
  • Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy for oral SCC is permissible if disease free for 1 year since prior oral cancer treatment and free of significant late radiation effects.
  • Severe active comorbidity such as uncontrolled cardiac disease, infection, severe Chronic Obstructive Pulmonary Disease (COPD).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: PK Analysis of Antitumor B in Patients With Oral Cancer

A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Similar to a phase 0 study, the trial design permits examination of the biologic effects of an agent; in this study pharmacokinetic properties will be examined.

Read the detailed description

Study Intervention Description:

Study participants will take the natural botanical compound ATB during a short window (7 to 28 days). Participants will provide blood samples, and saliva samples during Anti-tumor B (ATB) administration and a portion of the initial tumor biopsy.

Being tested
Antitumor B
Keywords
Anti-tumor B, ACAPHA, Pharmacokinetics
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antitumor BDrug

    Also called Zeng Sheng Ping, ATB, ACAPHA

    Study participants will take the natural botanical compound ATB during a short window (seven to 28 days). It will be administered at a dose of 1200 mg three times per day (roughly spaced every 8 hours).

Study groups in NCT03459729
Study groupRoleWhat they receive
Antitumor BExperimentalATB will be administered on an outpatient basis.
Receives: Drug: Antitumor B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Curve (AUC) for Matrine in Saliva

    The total systemic exposure to matrine as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted matrine concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

    Measured: Day 1

  2. Area Under the Curve for Matrine in Plasma

    The total systemic exposure to matrine as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted matrine concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

    Measured: Day 1

  3. Maximum Concentration (Cmax) of Matrine in Saliva

    This measure is the maximum concentration observed. The results will be reported in ng/ml.

    Measured: Day 1

  4. Maximum Concentration of Matrine in Plasma

    This measure is the maximum concentration observed. The results will be reported in ng/ml.

    Measured: Day 1

  5. Area Under the Curve (AUC) for Maackiain in Saliva

    The total systemic exposure to maackiain as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted maackiain concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

    Measured: Day 1

  6. Area Under the Curve (AUC) for Maackiain in Plasma

    The total systemic exposure to maackiain as represented by the AUC will be calculated as the area bounded by the x-axis and the line drawn as straight segments through the plotted maackiain concentrations at the time points: predose (0 minutes), 30 minutes, 60 minutes, 120 minutes, 180 minutes, 240 minutes, 360 minutes, 480 minutes, and 1,440 minutes. The results will be reported in (ng x hour)/ml.

    Measured: Day 1

  7. Maximum Concentration of Maackiain in Saliva

    This measure is the maximum concentration observed. The results will be reported in ng/ml.

    Measured: Day 1

  8. Maximum Concentration of Maackiain in Plasma

    This measure is the maximum concentration observed. The results will be reported in ng/ml.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2018
  2. Study start24 Aug 2021
  3. Primary completion15 Feb 2022
  4. Study completion16 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459729
Sponsor's protocol ID
PRO36718
Other IDs
R01CA205633
Status last verified
Jan 2025
First submitted
1 Mar 2018
Last updated
16 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.

    PubMed 28094848

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Antitumor B in people with Squamous Cell Carcinoma of the Oral Cavity, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUC) for Matrine in Saliva (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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