An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer

NCT03077698 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: VX-EC-2-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 25

Brief 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 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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Recurrent or persistent endometrial carcinoma; Progesterone Receptor Negative; Sodium Cridanimod

Outcome Measures

Primary Outcomes (1)

• 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

  During TP2 Every 12 weeks, until disease progression up to 24 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  24 months

• Progression-free Survival (PFS)

  24 months

• Duration of Stable Disease

  24 months

• Overall Survival (OS)

  12 months

Study Arms (1)

Sodium Cridanimod & progestin therapy

EXPERIMENTAL

Sodium Cridanimod and progestin therapy (megestrol acetate) combination

Drug: Sodium Cridanimod; Drug: progestin therapy

Interventions

Sodium Cridanimod DRUG

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.

Sodium Cridanimod & progestin therapy

progestin therapy DRUG

The study will investigator the use of progestin therapy in conjunction with Sodium Cridanimod

Also known as: megestrol acetate

Sodium Cridanimod & progestin therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females with endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Xenetic Biosciences, Inc.: lead

Study Sites (25)

Providence St. Joseph Medical Center - Gynecology

Burbank, California, 91505, United States

Location

University of California - Irvine Healthcare

Irvine, California, 92697, United States

Location

UCLA

Los Angeles, California, 90024, United States

Location

St. Josephs Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

University of Colorado School of Medicine, Division of Gynecologic Oncology

Aurora, Colorado, 80045, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Northside Hospital [University Gynecologic Oncology]

Atlanta, Georgia, 30342, United States

Location

MUMC - Curtis and Elizabeth Anderson Cancer Institute

Savannah, Georgia, 31404, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40508, United States

Location

Women's Cancer Care [Mary Bird Cancer Center at Tammany Parish Hospital]

Covington, Louisiana, 70433, United States

Location

St. Dominic-Jackson Memorial Hospital

Jackson, Mississippi, 39216, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27517, United States

Location

University of Cincinnati Cancer Institute-UC Health Barrett Center

Cincinnati, Ohio, 45219, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Magee Women's Hospital (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Rapid City Regional Cancer Care

Rapid City, South Dakota, 57701, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

UT Galveston; University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Interventions

10-carboxymethyl-9-acridanone; Estrogen Replacement Therapy; Megestrol Acetate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Replacement Therapy; Drug Therapy; Therapeutics; Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was discontinued early due to a change in development strategy and not due safety concern. No safety concerns were noted during the trial. This change in development strategy was the determining factor in the decision to discontinue the study. Because the study was terminated early, the planned analysis was not conducted, as full enrollment was not met.

Results Point of Contact

• Title: Dr. Curtis Lockshin
• Organization: Xenetic Biosciences Inc

info@xeneticbio.com

781-778-7720

Study Officials

• Curtis Lockshin, PhD

  Xenetic Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2, Single Arm, Two Period Study

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 13, 2017
• Study Start: June 14, 2017
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: June 7, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)