Actively Recruiting
Phase II Study of CPI-613 (Devimistat) with Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Advanced Chemorefractory Solid Tumors
Led by Northwestern University · Updated on 2023-03-10
94
Participants Needed
1
Research Sites
112 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
Researchers are evaluating the combination of CPI-613 (devimistat) with hydroxychloroquine (HCQ) and either 5-fluorouracil (5-FU) or gemcitabine in patients with advanced solid tumors that have spread or not responded to chemotherapy. This phase II trial aims to estimate the overall response rate and assess progression-free survival, overall survival, duration of response, safety, and tolerability. The study includes patients with colorectal, pancreatic, gastroesophageal, urothelial, ovarian, non-small cell lung, and biliary cancers. Participants are assigned to one of three groups based on cancer type and receive a combination of intravenous devimistat plus either 5-FU or gemcitabine, along with oral hydroxychloroquine. Patients with colorectal, pancreatic, or gastroesophageal cancers receive devimistat, 5-FU, and HCQ. Those with urothelial, ovarian, non-small cell lung, or biliary tumors receive devimistat, gemcitabine, and HCQ or devimistat with gemcitabine or HCQ. Treatment involves multiple cycles with blood sample collection and imaging using CT or MRI to monitor disease. During the study, participants undergo regular imaging scans and blood collections for molecular and metabolic analyses. Researchers measure tumor response, time to disease progression, survival times, and safety outcomes up to 24 months. The study also monitors adverse events for 30 days after treatment. Patients must be available and willing to comply with study procedures, including consenting and attending all visits for the duration of the trial, which extends through the treatment and follow-up periods.
CONDITIONS
Brief 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 colorectal, pancreatic, biliary, gastroesophageal, urothelial, ovarian, or non-small cell lung cancer that is advanced or refractory to standard treatments.
- Patients must have measurable disease according to RECIST v1.1 criteria.
- Radiographic confirmation of metastatic disease with imaging within 6 weeks prior to enrollment.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (status 2 allowed with principal investigator approval).
- Exhausted all available molecularly targeted therapies if applicable.
- Blood counts and organ function within specified limits within 14 days of screening.
- Use of adequate contraception for patients of child-bearing potential during study and for 180 days after.
- Negative pregnancy test for patients of child-bearing potential prior to registration.
- Controlled viral infections (HIV, HBV, HCV) as specified.
- Ability to understand and willingness to sign informed consent.
- Willingness to comply with study procedures and availability for the study duration.
You will not qualify if you...
- Patients with unresolved side effects from prior anti-cancer therapy above grade 1, except alopecia and peripheral neuropathy.
- Symptomatic brain metastases requiring corticosteroids.
- Severe lung disease or recent myocardial infarction within 90 days.
- Use of medications that prolong QT interval such as amiodarone.
- History of risk factors for drug-induced QT prolongation or Torsades de Pointes.
- Recent major surgery or significant injury within 21 days.
- Recent chemotherapy or radiotherapy within 21 days (42 days for some drugs).
- Uncontrolled infections or significant gastrointestinal complications within 42 days.
- Symptomatic heart failure, coronary artery disease, angina, or unstable cardiac conditions.
- Psychiatric or social conditions limiting compliance.
- Active substance abuse.
- Pregnancy or nursing.
- Prolonged QTc interval or certain ECG abnormalities.
- Pre-existing eye retinopathy.
- Inability to swallow or absorb oral medications.
- Known hypersensitivity to study drugs or components.
- Poorly controlled diabetes mellitus with specified glucose or HbA1c levels.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or discontinuation
Participants receive devimistat intravenously along with hydroxychloroquine orally and either 5-fluorouracil or gemcitabine intravenously depending on their cohort and cancer type. Imaging scans such as CT and/or MRI and blood specimen collections occur throughout the treatment period to monitor response and safety.
Regular imaging and blood collection visits during treatment
Duration - Up to 30 days post treatment
Participants are monitored for up to 30 days after treatment ends to assess safety and check for any adverse events.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
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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