Squamous Cell CarcinomaPhase 2NCT00605709
Dose-Ranging Safety and Efficacy Study of Topical Creams Containing API 31510 for the Treatment of in Situ Cutaneous Squamous Cell Carcinoma
A Phase 2 study testing API 31510 Topical Cream in people with Squamous Cell Carcinoma, run by BPGbio.
Trial summary
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- API 31510 Topical Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female adults ≥ 18 years of age
- Primary, histologically confirmed SCCIS with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target SCCIS lesion suitable for excision
- Histological diagnosis made no more than 4 weeks prior to the screening visit
- Histological biopsy removed 25% or less of the target lesion
- No other dermatological disease in the SCCIS target site or surrounding area
- Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. Willing to refrain from washing the treated area for at least 8 hours following the application of study medication
Show all 12Show fewer
- Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
- Laboratory values for the tests listed in the Study Schedule on page 2 within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator.
- Ability to follow study instructions and likely to complete all study requirements
- Written informed consent obtained, including consent for tissue to be examined and stored by the central dermatopathologist
- Written consent to allow photographs of the target SCCIS lesion to be used as part of the study data
- For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy)
Who cannot join
- Pregnant or lactating
- Presence of known or suspected systemic cancer
- Histological evidence of nBCC, sBCC, or any other tumor in the biopsy specimen
- Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen
- History of recurrence of the target SCCIS lesion
- Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., BCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa
Show all 21Show fewer
- Concurrent disease or treatment that suppresses the immune system
- Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk
- Known sensitivity to any of the ingredients in the study medication
- Use of a tanning parlor or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the course of the study
- Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit
- Use of systemic retinoids within the 6 months prior to the screening period
- Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period
- Use of topical immunomodulators within 2 cm of the target SCCIS lesion within the 4 weeks prior to the screening period
- Treatment with the following topical agents within the 4 weeks prior to the screening visit: levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod
- Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the 6 months prior to the screening visit, if the target SCCIS lesion is on the face
- Treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target SCCIS lesion during the 4 weeks prior to the screening visit
- Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the treatment period
- Evidence of current chronic alcohol or drug abuse
- Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit
- In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study
About this study
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- API 31510 Topical Cream
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
API 31510 Topical CreamDrug
Topical treatments to lesion twice daily of randomized treatments.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active Cream 3% ; AM \& PM Receives: Drug: API 31510 Topical Cream |
| 2 | Active comparator | Placebo Cream AM; 3% Active Cream PM Receives: Drug: API 31510 Topical Cream |
| 3 | Active comparator | Placebo Cream AM; 1.5% Active Cream PM Receives: Drug: API 31510 Topical Cream |
| 4 | Placebo comparator | Placebo Cream AM \& PM Receives: Drug: API 31510 Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be the proportion of subjects with a complete response for the Intent-to-Treat (ITT) population.
Measured: 8 weeks
Secondary outcomes (1)
The secondary efficacy endpoint is the proportion of subjects with a partial response in the ITT population.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BPGbio
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605709
- Sponsor's protocol ID
- CTL0208
- Status last verified
- Jul 2012
- First submitted
- 18 Jan 2008
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Ranging Safety and Efficacy Study of Topical Creams Containing API 31510 for the Treatment of in Situ Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00605709
- Acronym / sponsor ID
- CTL0208
- Conditions
- Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BPGbioIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (estimated)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: API 31510 Topical CreamActive Cream 3% ; AM \& PM |
| 2 | Active comparator | Drug: API 31510 Topical CreamPlacebo Cream AM; 3% Active Cream PM |
| 3 | Active comparator | Drug: API 31510 Topical CreamPlacebo Cream AM; 1.5% Active Cream PM |
| 4 | Placebo comparator | Drug: API 31510 Topical CreamPlacebo Cream AM \& PM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female adults ≥ 18 years of age
- Primary, histologically confirmed SCCIS with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target SCCIS lesion suitable for excision
- Histological diagnosis made no more than 4 weeks prior to the screening visit
- Histological biopsy removed 25% or less of the target lesion
- No other dermatological disease in the SCCIS target site or surrounding area
Key exclusion criteria (21 listed)
- Pregnant or lactating
- Presence of known or suspected systemic cancer
- Histological evidence of nBCC, sBCC, or any other tumor in the biopsy specimen
- Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen
- History of recurrence of the target SCCIS lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| API 31510 Topical CreamTopical treatments to lesion twice daily of randomized treatments. | Drug | 1, 2, 3, 4 |
Primary outcome
The primary efficacy endpoint will be the proportion of subjects with a complete response for the Intent-to-Treat (ITT) population.
Time frame: 8 weeks
1 secondary outcome
The secondary efficacy endpoint is the proportion of subjects with a partial response in the ITT population.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
Related trials for Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing API 31510 Topical Cream in people with Squamous Cell Carcinoma, run by BPGbio.
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 12 inclusion and 21 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: withdrawn, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary efficacy endpoint will be the proportion of subjects with a complete response for the Intent-to-Treat (ITT) population. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2012.