Endometrial CancerPhase 2NCT03077698
An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer
A Phase 2 study testing Sodium Cridanimod and progestin therapy in people with Endometrial Cancer, run by Xenetic Biosciences, Inc. at 25 sites in United States.
Trial summary
This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Sodium Cridanimod and progestin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 25 sitesUnited States
- Study dates
- 14 Jun 2017to 17 Jul 2020
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years of age or older;
- Histologically confirmed serous carcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);
- Recurrent or persistent progressive disease which is refractory to curative therapy or established treatments and cannot be treated with surgery or radiotherapy;
- Measurable disease, as defined by RECIST 1.1 criteria;
- At least one "target lesion" to be used to assess response, as defined by RECIST 1.1 criteria. Tumors within a previously irradiated field will be designated as "non-target" lesions unless previous progression is documented;
- Availability of archived tumor tissue sample that can be used for assessment of PrR status by the central laboratory;
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- GOG (Gynecologic Oncology Group) performance status 0-2 (refer to Appendix A);
- Calculated Glomerular filtration rate ≥ 50 mL/min;
- Total bilirubin ≤ 2.5 times upper limit of normal (ULN);
- AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
- Albumin ≥ 3.0 mg/dL;
- Ability to take oral medication;
- Patients able to understand the nature of the study and who are willing to give written informed consent;
- And for Treatment Period 2 only: 1) Patients participating in Treatment Period 1 must have had disease progression after receiving at least 4 weeks of progestin therapy or 2) Patients must be determined as PrR negative status at Screening.
Who cannot join
- Mixed histology of the tumor or evidence of tumor histology other than serous carcinoma or endometrioid type of endometrial carcinoma;
- Concurrent systemic corticosteroid therapy;
- Concurrent oral contraceptive use / Women of childbearing potential not using highly effective means of contraception;
- Pregnancy confirmed by pregnancy test / Lactating women;
- Prior therapy with hormonal progestin agents;
- Patients who are candidates for treatment with standard chemotherapy agents (there is no limit to the number of lines of chemotherapy);
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- History of blood clot;
- History of known bleeding disorder (i.e. disseminated intravascular coagulation or clotting factor deficiency);
- Major surgery within 4 weeks prior to the start of the study;
- Patients with clinically significant illnesses which, according to the Investigator, could compromise participation in the study;
- History of other clinically active malignancies within 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma, or squamous carcinoma of the skin.
- Known hypersensitivity or idiosyncratic reaction to any of the study drugs (Sodium Cridanimod, megestrol acetate, lidocaine) and excipients;
- Patients with known brain metastases;
- Patients currently receiving any other investigational agents;
- Patients currently receiving any other anticancer therapies;
- Participation in any other clinical study within the last 4 weeks prior to the start of the study
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Northside Hospital [University Gynecologic Oncology]
Atlanta, Georgia, 30342
University of Colorado School of Medicine, Division of Gynecologic Oncology
Aurora, Colorado, 80045
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Providence St. Joseph Medical Center - Gynecology
Burbank, California, 91505
RUSH University Medical Center
Chicago, Illinois, 60612
University of Cincinnati Cancer Institute-UC Health Barrett Center
Cincinnati, Ohio, 45219
Women's Cancer Care [Mary Bird Cancer Center at Tammany Parish Hospital]
Covington, Louisiana, 70433
UT Southwestern
Dallas, Texas, 75390
UT Galveston; University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555
University of California - Irvine Healthcare
Irvine, California, 92697
St. Dominic-Jackson Memorial Hospital
Jackson, Mississippi, 39216
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40508
UCLA
Los Angeles, California, 90024
Columbia University Medical Center
New York, New York, 10032
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Magee Women's Hospital (UPMC)
Pittsburgh, Pennsylvania, 15213
Rapid City Regional Cancer Care
Rapid City, South Dakota, 57701
St. Josephs Heritage Healthcare
Santa Rosa, California, 95403
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
MUMC - Curtis and Elizabeth Anderson Cancer Institute
Savannah, Georgia, 31404
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27517
About this study
Official title: A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma
This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as Progesterone Receptor (PrR) negative. All patients must have endometrial cancer PrR status determined from an archival sample at Screening. The PrR status (positive or negative) will be determined by central laboratory by ImmunoHistoChemistry (IHC) testing.
There are two treatment periods and a follow-up period within the study.
Read the detailed description
Treatment Period 1 (Progestin Monotherapy): During Treatment Period 1, all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks. Subjects will have an MRI or CT scan after 12 and 24 weeks of progestin monotherapy, with response to treatment being assessed according to RECIST 1.1 criteria. All subjects that achieve disease control confirmed by tumor assessment after Treatment Period 1, will be ineligible to enter Treatment Period 2. These subjects will be terminated from the trial and treated according to local standards of practice, which may include continued progestin therapy.
Subjects determined to be PrR negative at Screening will not enroll into Treatment Period 1. These subjects will enroll directly into Treatment Period 2.
Treatment Period 2 (Combination Treatment): All subjects determined to be PrR negative at Screening and those who received at least 4 weeks of progestin monotherapy and who experienced disease progression at the conclusion of Treatment Period 1 will enter Treatment Period 2 of the study. During Treatment Period 2, subjects will receive Sodium Cridanimod in combination with continued progestin treatment, megestrol acetate. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria, with response assessments performed at 12-week intervals.
Follow-up Period: Once subjects progress during Treatment Period 2, they will return for a Safety Follow-up Visit 4 weeks following the last treatment, and then continue to be followed for an additional 12-month period for overall survival.
- Conditions
- Endometrial Cancer
- Being tested
- Sodium Cridanimod, progestin therapy
- Keywords
- Endometrial cancer, Recurrent or persistent endometrial carcinoma, Progesterone Receptor Negative, Sodium Cridanimod
- Medical subject headings
- Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium CridanimodDrug
The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative.
progestin therapyDrug
Also called megestrol acetate
The study will investigator the use of progestin therapy in conjunction with Sodium Cridanimod
| Study group | Role | What they receive |
|---|---|---|
| Sodium Cridanimod & progestin therapy | Experimental | Sodium Cridanimod and progestin therapy (megestrol acetate) combination Receives: Drug: Sodium Cridanimod; Drug: progestin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements
Subjects in the Full Analysis Set (FAS) population will be assessed for ODC. The FAS population includes those subjects all treated in TP2 who either undergo a CT or MRI scan with tumor assessment at 12 weeks (i.e. they have not discontinued treatment prior to 12 weeks) or those who have discontinued TP2 prior to 12 weeks solely due to documented disease progression. Radiographic disease progression and responses will be defined using RECIST 1.1 criteria:
Control Response(CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. The appearance of new lesions is also considered progression.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Measured: During TP2 Every 12 weeks, until disease progression up to 24 months
Secondary outcomes (4)
Objective Response Rate (ORR)
The best overall response was the best response recorded from the start of Treatment Period 2 until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).To be assigned a status of CR or PR, tumor measurements were confirmed by repeat assessment performed at least four weeks after the criteria for response are first met. Best Overall Response (OR) was determined based on the following combinations of repeat assessments: CR + CR = CR, CR + PR= SD, PD or PR, CR + SD =SD, CR+ PD = SD, CR + NEW= SD, PR + CR= PR, PR + PR= PR, PR+ SD= SD, PR + PD= SD, PR+ NEW = SD.
Measured: 24 months
Progression-free Survival (PFS)
Progressive Disease was assessed using RECIST Guideline (version 1.1) whereas at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Progression-free Survival (PFS) was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until disease progression or death from any cause, whichever occurs first. For the purpose of analysis of PFS, subjects with an unknown response were censored.
Measured: 24 months
Duration of Stable Disease
Stable Disease (SD) was assessed using RECIST Guideline (version 1.1) whereas neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Duration of Stable Disease was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the criteria for disease progression were first met. For the purpose of analysis of Duration of SD, subjects who died before documented progressive disease were censored.
Measured: 24 months
Overall Survival (OS)
Once disease progression was documented in Treatment Period 2, subjects returned for the Safety Follow-up Visit four (4) weeks following the last treatment and continued to be followed for an additional 12-month period for overall survival. Overall Survival (OS) was defined as the duration of time from initiation of Treatment Period 2 (Day 0) until the subject's death from any cause. For the purpose of analysis of OS, if a subject is alive at the date of last contact the subject was censored at that date of contact.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start14 Jun 2017
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Why it stopped: The study was discontinued due to a change in development strategy and not due safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 2, Single Arm, Two Period Study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenetic Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curtis Lockshin, PhD, Study director, Xenetic Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077698
- Sponsor's protocol ID
- VX-EC-2-02
- Status last verified
- May 2022
- First submitted
- 27 Feb 2017
- Last updated
- 7 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT03077698
- Acronym / sponsor ID
- VX-EC-2-02
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Recurrent or persistent endometrial carcinoma, Progesterone Receptor Negative, Sodium Cridanimod
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to a change in development strategy and not due safety concern.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Xenetic Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 7 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center, single-arm, two-period Phase 2 study. The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with recurrent or persistent endometrial cancer, who have failed progestin monotherapy or who have been identified as Progesterone Receptor (PrR) negative. All patients must have endometrial cancer PrR status determined from an archival sample at Screening. The PrR status (positive or negative) will be determined by central laboratory by ImmunoHistoChemistry (IHC) testing.
There are two treatment periods and a follow-up period within the study.
Detailed description
Treatment Period 1 (Progestin Monotherapy): During Treatment Period 1, all subjects determined to be PrR positive will receive progestin monotherapy, megestrol acetate, for up to 24 weeks. Subjects will have an MRI or CT scan after 12 and 24 weeks of progestin monotherapy, with response to treatment being assessed according to RECIST 1.1 criteria. All subjects that achieve disease control confirmed by tumor assessment after Treatment Period 1, will be ineligible to enter Treatment Period 2. These subjects will be terminated from the trial and treated according to local standards of practice, which may include continued progestin therapy.
Subjects determined to be PrR negative at Screening will not enroll into Treatment Period 1. These subjects will enroll directly into Treatment Period 2.
Treatment Period 2 (Combination Treatment): All subjects determined to be PrR negative at Screening and those who received at least 4 weeks of progestin monotherapy and who experienced disease progression at the conclusion of Treatment Period 1 will enter Treatment Period 2 of the study. During Treatment Period 2, subjects will receive Sodium Cridanimod in combination with continued progestin treatment, megestrol acetate. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria, with response assessments performed at 12-week intervals.
Follow-up Period: Once subjects progress during Treatment Period 2, they will return for a Safety Follow-up Visit 4 weeks following the last treatment, and then continue to be followed for an additional 12-month period for overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2, Single Arm, Two Period Study
| Arm | Type | Receives |
|---|---|---|
| Sodium Cridanimod & progestin therapy | Experimental | Drug: Sodium Cridanimod, Drug: progestin therapySodium Cridanimod and progestin therapy (megestrol acetate) combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients 18 years of age or older;
- Histologically confirmed serous carcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);
- Recurrent or persistent progressive disease which is refractory to curative therapy or established treatments and cannot be treated with surgery or radiotherapy;
- Measurable disease, as defined by RECIST 1.1 criteria;
- At least one "target lesion" to be used to assess response, as defined by RECIST 1.1 criteria. Tumors within a previously irradiated field will be designated as "non-target" lesions unless previous progression is documented;
Key exclusion criteria (16 listed)
- Mixed histology of the tumor or evidence of tumor histology other than serous carcinoma or endometrioid type of endometrial carcinoma;
- Concurrent systemic corticosteroid therapy;
- Concurrent oral contraceptive use / Women of childbearing potential not using highly effective means of contraception;
- Pregnancy confirmed by pregnancy test / Lactating women;
- Prior therapy with hormonal progestin agents;
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 |
|---|---|---|
| Sodium CridanimodThe study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative. | Drug | Sodium Cridanimod & progestin therapy |
| progestin therapyAlso: megestrol acetateThe study will investigator the use of progestin therapy in conjunction with Sodium Cridanimod | Drug | Sodium Cridanimod & progestin therapy |
Primary outcome
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements
Time frame: During TP2 Every 12 weeks, until disease progression up to 24 months
Subjects in the Full Analysis Set (FAS) population will be assessed for ODC. The FAS population includes those subjects all treated in TP2 who either undergo a CT or MRI scan with tumor assessment at 12 weeks (i.e. they have not discontinued treatment prior to 12 weeks) or those who have discontinued TP2 prior to 12 weeks solely due to documented disease progression. Radiographic disease progression and responses will be defined using RECIST 1.1 criteria: Control Response(CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. The appearance of new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 24 months
Progression-free Survival (PFS)
Time frame: 24 months
Duration of Stable Disease
Time frame: 24 months
Overall Survival (OS)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Curtis Lockshin, PhD study director
Xenetic Biosciences, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Cridanimod and progestin therapy in people with Endometrial Cancer, run by Xenetic Biosciences, Inc. at 25 sites 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 15 inclusion and 16 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: stopped early, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
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?
Yes. Results are posted in the registry (first posted 7 Jun 2022). 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?
Overall Disease Control (ODC) as Determined by Radiographic Imaging Measurements (time frame: During TP2 Every 12 weeks, until disease progression up to 24 months). 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 7 Jun 2022.