Squamous Cell Carcinoma of the CervixPhase 2NCT01639625
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application
A Phase 2 study testing CIGB300 in people with Squamous Cell Carcinoma of the Cervix and Adenocarcinoma of the Cervix, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial summary
They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Squamous Cell Carcinoma of the Cervix, Adenocarcinoma of the Cervix
- What is being tested?
- CIGB300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteArgentina
- Study dates
- May 2011to Jan 2016
- 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stages IIA and IIB FIGO classification.
- Age between 21 to 70 years.
- ECOG performance status 0-1.
- No history of another neoplastic disease.
- Value of Hemoglobin ≥ 9 g / l.
- Total leukocyte count ≥ 3.0 x 109 / L.
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- Absolute neutrophil count ≥ 1.5 x 109 / L.
- Platelets ≥ 100,000 x mm3.
- Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
- Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula)
- Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.
- Life expectancy ≥ 12 months
- Measurable disease
- Informed consent signed by the patient
Who cannot join
- Pregnancy and lactation period.
- Presence of lymph node metastases or hematogenous extrapelvic known.
- Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
- Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
- Hepatitis B or C active, positive serology for HIV.
- Atopy history of severe / severe asthma.
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- A history of autoimmune disease.
- Presence of significant abnormalities in ECG performed within 14 days prior to admission.
- Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.
- Participating in another clinical trial "
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Oncologia Angel H. Roffo
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1417DTB
About this study
Official title: Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation
They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.
- Being tested
- CIGB300
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIGB300Drug
CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.
| Study group | Role | What they receive |
|---|---|---|
| CIGB300 | Experimental | Not described Receives: Drug: CIGB300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level
Measured: Up to 2 years
Secondary outcomes (2)
Number of patients with local relapses
Measured: Up to 2 years
Number of patients with distant relapses
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the CervixStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639625
- Sponsor's protocol ID
- 300CX02AR01
- Status last verified
- Aug 2016
- First submitted
- 15 Jun 2012
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation
- ClinicalTrials.gov ID
- NCT01639625
- Acronym / sponsor ID
- 300CX02AR01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Jul 2012 (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.
They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIGB300 | Experimental | Drug: CIGB300 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Stages IIA and IIB FIGO classification.
- Age between 21 to 70 years.
- ECOG performance status 0-1.
- No history of another neoplastic disease.
- Value of Hemoglobin ≥ 9 g / l.
Key exclusion criteria (10 listed)
- Pregnancy and lactation period.
- Presence of lymph node metastases or hematogenous extrapelvic known.
- Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
- Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
- Hepatitis B or C active, positive serology for HIV.
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 |
|---|---|---|
| CIGB300CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application. | Drug | CIGB300 |
Primary outcome
Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level
Time frame: Up to 2 years
2 secondary outcomes
Number of patients with local relapses
Time frame: Up to 2 years
Number of patients with distant relapses
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CIGB300 in people with Squamous Cell Carcinoma of the Cervix and Adenocarcinoma of the Cervix, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
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 14 inclusion and 10 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 2 Aug 2016. 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 Argentina. 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?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level (time frame: Up to 2 years). 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 2 Aug 2016.