Actively Recruiting
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
Led by Northwestern University · Updated on 2023-03-10
94
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.
CONDITIONS
Official Title
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed cancer unresponsive or intolerant to standard curative treatments.
- Patients in cohort 1 must have colorectal cancer.
- Patients in cohort 2 must have pancreatic cancer.
- Patients in cohort 3 may have biliary, gastroesophageal, urothelial, ovarian, or non-small cell lung adenocarcinoma.
- Patients must have measurable disease per RECIST v1.1.
- Patients must have imaging showing metastatic disease within 6 weeks prior to registration.
- Patients must be 18 years or older.
- Patients must have ECOG performance status 0 or 1; status 2 allowed with PI approval.
- Patients must have exhausted all molecularly targeted therapies.
- Absolute neutrophil count ≥ 1,500/mcL within 14 days prior to screening.
- Hemoglobin ≥ 9 g/dL within 14 days prior to screening (transfusions permitted).
- Platelets ≥ 100,000/mcL within 14 days prior to screening (transfusions permitted).
- INR ≤ 1.6 within 14 days prior to screening (≤ 3.0 if on anticoagulants without active bleeding).
- Total bilirubin ≤ 1.5 x ULN (≤ 2.0 mg/dL for Gilbert's Syndrome or liver metastases without obstruction).
- AST ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases present).
- ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases present).
- Serum albumin > 3.0 g/dL within 14 days prior to screening.
- Creatinine ≤ 1.5 x ULN or GFR ≥ 50 mL/min/1.73 m² within 14 days prior to screening.
- Patients of child-bearing potential and partners must use effective contraception during and 180 days after study.
- Negative pregnancy test prior to registration.
- Patients with HIV must have undetectable viral load for 6 months on treatment.
- Patients with chronic HBV must have undetectable viral load on therapy.
- Patients with HCV must be treated and cured or have undetectable viral load if on treatment.
- Patients with cardiac history must be NYHA class 2B or better and evaluated if pacemaker present.
- Patients must understand and voluntarily sign informed consent.
- Patients must be reliable and willing to comply with study procedures.
You will not qualify if you...
- Patients not recovered from prior anti-cancer therapy side effects greater than grade 1 (except alopecia and peripheral neuropathy).
- Patients with symptomatic brain metastases using corticosteroids.
- Patients with severe obstructive pulmonary disease or interstitial lung disease.
- Patients with myocardial infarction within 90 days prior to registration.
- Patients using medications that prolong QT interval such as amiodarone.
- Patients with other risk factors for QT prolongation or Torsades de Pointes.
- Patients with major surgery or significant injury within 21 days prior to registration.
- Patients receiving chemotherapy or radiation within 21 days prior to registration (42 days for certain agents).
- Patients with uncontrolled infection or recent significant gastrointestinal complications.
- Patients with symptomatic congestive heart failure, coronary artery disease, angina, or unstable cardiac conditions.
- Patients with psychiatric or social issues limiting study compliance.
- Active substance abuse.
- Patients pregnant or nursing.
- Patients with QTcF > 470 msec (female) or > 450 msec (male) or congenital long QT syndrome.
- Patients with pre-existing eye retinopathy.
- Patients unable to swallow or absorb oral medication.
- Patients allergic to CPI, 4-aminoquinoline compounds, or quinine.
- Patients with poorly controlled diabetes (HbA1c > 7%, glucose thresholds exceeded).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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