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Tests treatment safety and results for Ovarian Cancer
Official title A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine
ClinicalTrials.gov ID: NCT03854110
What this study is testing
What is misetionamide (also known as GP-2250)?
misetionamide (also known as GP-2250) is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Also referred to as gemcitabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1 dose escalation trial of monotherapy misetionamide (also known as GP-2250) currently enrolling patients with platinum-resistant ovarian cancer (PROC) into Part 2 of the study. Part 1 of the study evaluating misetionamide in combination with gemcitabine in subjects with advanced pancreatic cancer previously treated with 5-fluorouracil-based chemotherapy completed enrolment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Abridged
- Capable of giving signed informed consent: Regulatory, Ethical, and Trial Oversight Considerations which includes compliance with the requirements...
- people age \> 18 years at the time of trial entry.
- Pathologically proven platinum-resistant epithelial ovarian, fallopian, or primary peritoneal cancer, with high-grade serous ovarian carcinoma...
- Maximum of 2 prior regimens for platinum-resistant disease. people who are positive for high FR alpha (defined per the FDA approved companion...
You likely can't join if
- Diagnosis of any active malignancy other than platinum-resistant ovarian cancer within the past 2 years (not including non-melanoma skin carcinoma...
- people has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic...
- Primary refractory disease (defined as failure to achieve at least a partial response (PR) to their initial platinum-based chemotherapy).
- Radiotherapy (RT) to target lesions, chemotherapy, or other systemic anti-cancer therapy, including prior anti-angiogenic treatment (e.g...
- Ascites including history of therapeutic paracentesis within the 2 weeks prior to signing informed consent.
- Any other medical, psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare, or...
See the full eligibility criteria
- Abridged
- Capable of giving signed informed consent: Regulatory, Ethical, and Trial Oversight Considerations which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this...
- people age \> 18 years at the time of trial entry.
- Pathologically proven platinum-resistant epithelial ovarian, fallopian, or primary peritoneal cancer, with high-grade serous ovarian carcinoma (HGSOC) or a predominantly serous/endometroid component. Platinum-resistant...
- Maximum of 2 prior regimens for platinum-resistant disease. people who are positive for high FR alpha (defined per the FDA approved companion diagnostic test (ELAHERE prescribing information) must have received MIRV...
- CT/MRI evidence of measurable disease per RECIST Version 1.1 defined as at least one lesion not previously irradiated that can be measured at baseline as 10 mm in the longest diameter (except lymph nodes which must have...
- ECOG performance status of 0-1
- people with known central nervous system metastasis must have undergone brain targeted treatment and must be asymptomatic or radiographically and clinically stable (including not requiring steroids or anti-seizure...
- people must have adequate organ function as indicated by the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1,500 /mL
- Platelets ≥ 100,000 / mL
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 × ULN
- Aspartate aminotransferase (AST), (Serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT), and (Serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × ULN OR ≤ 5 × ULN for people with liver...
- International Normalized Ratio (INR) and/or Prothrombin Time (PT) ≤ 1.5 × ULN
- Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
- Serum Albumin ≥ 3 g/dL measured at two time points: no less than 2 weeks before the 1st dose of misetionamide and within one week prior to the 1st dose. people showing a decrease of \> 20% at the 2nd measurement are...
- Limited concomitant radiotherapy for pain control is allowed in the 5 weeks prior to initial dose.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test.
- people must use adequate contraception for the duration of the trial and for at least 3 months after the last dose and refrain from tissue donation during this period. .
- All acute toxic effects of any prior anti-tumor therapy resolved to Grade \< 1or baseline before start of dosing (exceptions are alopecia and Grade 2 peripheral neuropathy). Abridged
- Diagnosis of any active malignancy other than platinum-resistant ovarian cancer within the past 2 years (not including non-melanoma skin carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of uterine...
- people has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonia or multiple...
- Primary refractory disease (defined as failure to achieve at least a partial response (PR) to their initial platinum-based chemotherapy).
- Radiotherapy (RT) to target lesions, chemotherapy, or other systemic anti-cancer therapy, including prior anti-angiogenic treatment (e.g. bevacizumab) within 4 weeks prior to starting treatment.
- Ascites including history of therapeutic paracentesis within the 2 weeks prior to signing informed consent.
- Any other medical, psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate and participate in the...
- Subject has undergone major surgery, other than diagnostic surgery within 4 weeks prior to Day 1 of treatment in this study.
- Prior history or current signs of hyphema or glaucoma.
- History of sickle cell disease or hereditary non-spherocytic hemolytic anemia.
- Baseline QTc interval \>480 msec for female people or \>450 msec for male people.
- Subject is unwilling or unable to comply with study procedures or planning to take a vacation for \>7 consecutive days during the course of the study.
- First degree relative of the investigator, study staff or the sponsor.
- Any chemotherapy administered within 3 weeks or 5 half-lives (whichever is shorter) before first dose of misetionamide; other anti-cancer therapy (including surgery, radiotherapy, immunotherapy, hormone therapy, or...
- Investigational therapy administered within 4 weeks or 5-half lives (whichever is shorter) before the first dose of misetionamide.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- Phildelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Fairway, Kansas, United States; Boston, Massachusetts, United States; Phildelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.