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New treatment option for Advanced Biliary Tract Carcinoma
Official title CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
ClinicalTrials.gov ID: NCT05733000
What this study is testing
What is Devimistat?
Devimistat is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced biliary tract carcinoma.
Also referred to as Alpha-Lipoic Acid Analogue CPI-613, CPI 613.
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 phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- Patients must have histologically confirmed cancer for which standard-of-care curative measures are no longer effective or be intolerant to those...
- Biliary
- Gastroesophageal
- Urothelial
- Ovarian
You likely can't join if
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1).
- Note: Patients who experience adverse events of alopecia and peripheral neuropathy that have not recovered are eligible; patients with any lab...
- Patients with symptomatic brain metastases currently using corticosteroids.
- Note: Patients with brain metastases who are asymptomatic and off corticosteroids for at least one week are eligible.
- Patients with severe obstructive pulmonary disease or interstitial lung disease.
- Patients with a history of myocardial infarction that is \<90 days prior to registration.
See the full eligibility criteria
Who can join
- Patients must have histologically confirmed cancer for which standard-of-care curative measures are no longer effective or be intolerant to those agents. Patients in cohort 1 must have colorectal cancer. Patients in...
- Biliary
- Gastroesophageal
- Urothelial
- Ovarian
- Non-small cell lung (adenocarcinoma only)
- Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease.
- Patients must have radiographic documentation of metastatic disease with imaging within =\< 6 weeks prior to registration.
- Patients must be age \>= 18 years.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Performance Status of 2 will be allowed with approval from principle investigator (PI) on a case-by case basis.
- Note: Performance status of 2 will be allowed with approval from PI on a case-by case basis. Documentation of PI approval in these cases will be stored with inclusion/exclusion signed checklist for patient and/or in...
- Patients must have exhausted all available molecularly targeted therapies (e.g., anti-PD-1/anti-PD-L1 agents where indicated).
- Absolute neutrophil count (ANC) \>= 1,500/mcL (within the last 14 days of screening)
- Hemoglobin (Hgb) \>= 9 g/dL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \>= 7 days from transfusion).
- Platelets (PLT) \>= 100,000/mcL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \>= 7 days from transfusion).
- INR (international normalized ratio) =\< 1.6 (within the last 14 days of screening) (unless receiving anticoagulation therapy) If receiving anticoagulant: INR =\< 3.0 and no active bleeding, (i.e., no bleeding within 14...
- Total bilirubin =\<1.5 x Institutional upper limit of normal (ULN) (within the last 14 days of screening)
- Note: Patients with Gilbert's Syndrome are exempt. Patients with liver metastases with no significant bilirubin obstruction may have a total bilirubin level of =\< 2.0 mg/dL.
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) =\< 2.5 x institutional ULN (within the last 14 days of screening)
- Note: If liver metastases are present, then =\< 5 x ULN is allowed.
- Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) =\< 2.5 x institutional ULN (within the last 14 days of screening)
- Note: If liver metastases are present, then =\< 5 x ULN is allowed.
- Serum albumin \> 3.0 g/dL (within the last 14 days of screening)
- Creatinine =\ = 50 mL/min/1.73 m\^2 (within the last 14 days of screening)
- eGFR is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation
- The effects of combination treatment of CPI-613, 5-FU, gemcitabine, and HCQ on the developing human fetus are unknown. For this reason and because antineoplastic agents as well as other therapeutic agents used in this...
- Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar...
- Note: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
- POCBP must have a negative pregnancy test prior to registration on study.
- Note: If negative pregnancy test result is \>7 days from first dose of study treatment it must be repeated at time of first dose of study treatment (with any of the four drugs used in this study).
- For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment, must have an undetectable HCV viral load. Patients with...
- Note: Patients with pacemakers where corrected QT interval (QTc) is not a reliable measure will require an evaluation by a cardiologist to exclude co-existing cardiac conditions which would prohibit safe participation...
- Patients must have the ability to understand and the willingness to sign a written informed consent document for the duration of the entirety of the study.
- Patients must be reliable, willing to make themselves available for the duration of the entire study and willing to follow screening procedures.
What rules you out
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1).
- Note: Patients who experience adverse events of alopecia and peripheral neuropathy that have not recovered are eligible; patients with any lab abnormality that is above grade 1 related to previous therapy found to be...
- Patients with symptomatic brain metastases currently using corticosteroids.
- Note: Patients with brain metastases who are asymptomatic and off corticosteroids for at least one week are eligible.
- Patients with severe obstructive pulmonary disease or interstitial lung disease.
- Patients with a history of myocardial infarction that is \<90 days prior to registration.
- Patients using concomitant medications that prolong the QT/QTc intervals. For example, patients receiving amiodarone. Using amiodarone together with hydroxychloroquine can increase the risk of long QT syndrome that...
- Patients with a history of additional risk factors for drug-induced QT prolongation or Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- Patients with major surgery or significant traumatic injury =\< 21 days prior to registration.
- Patients receiving treatment with low dose chemotherapy concurrent with radiation =\< 21 days prior to registration. OR patients who have had chemotherapy or radiotherapy =\< 21 days (42 days for nitrosoureas or...
- Note: Palliative radiation before and during study participation is permissible providing it is not to a target lesion.
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
- Ongoing or active infection requiring systemic treatment.
- Clinically significant complications such as perforation, gastrointestinal bleeding, or diverticulitis within 42 days prior to registration.
- Symptomatic congestive heart failure; symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.
- Unstable angina pectoris.
- Unstable cardiac arrhythmia.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Active substance abuse.
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.
- Patients who are pregnant or nursing.
- Patients with Fridericia-corrected QT interval (QTcF) \> 470 msec (female) or \> 450 (male), or history of congenital long QT syndrome. Any electrocardiogram (ECG) abnormality that in the opinion of the investigator...
- Patients who have pre-existing retinopathy of the eye.
- Patients who are unable to swallow or retain and absorb oral medication
- Patients with known hypersensitivity to any of the following: CPI or its inactive components, 4-aminoquinoline compounds, or quinine.
- Patients with poorly controlled diabetes mellitus (glycosylated hemoglobin (HbA1c) of \> 7%, pre-prandial capillary plasma glucose \> 130mg/dl, and peak postprandial capillary plasma glucose of \> 180mg/dl).
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 all sexes, 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. 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.