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CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors

ConditionsAdvanced Biliary Tract CarcinomaAdvanced Colorectal CarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaAdvanced Lung AdenocarcinomaAdvanced Malignant Solid NeoplasmAdvanced Ovarian CarcinomaAdvanced Pancreatic CarcinomaAdvanced Urothelial CarcinomaClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Metastatic Biliary Tract CarcinomaMetastatic Colorectal CarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaMetastatic Lung AdenocarcinomaMetastatic Ovarian CarcinomaMetastatic Pancreatic CarcinomaMetastatic Urothelial CarcinomaRefractory Biliary Tract CarcinomaRefractory Colorectal CarcinomaRefractory Gastroesophageal Junction AdenocarcinomaRefractory Lung AdenocarcinomaRefractory Ovarian CarcinomaRefractory Pancreatic CarcinomaRefractory Urothelial CarcinomaStage II Pancreatic Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biliary

Gastroesophageal

Urothelial

Ovarian

Disqualifiers

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 not clinically significant will also be eligible.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Devimistat

    Drug

    Receive IV

  • Fluorouracil

    Drug

    Receive IV

  • Gemcitabine Hydrochloride

    Drug

    Receive IV

  • Hydroxychloroquine

    Drug

    Receive PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

94 Participants
are divided into 3 treatment groups
Group A: COHORT 1 (Devimistat, 5-FU, HCQ)Experimental treatment 6 interventions
Group B: COHORT 2 (Devimistat, 5-FU, HCQ)Experimental treatment 6 interventions
Group C: COHORT 3 (Devimistat, 5-FU, HCQ, Gemcitabine)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in patients with solid tumors treated under this protocol. ORR is defined as the percentage of patients with documented complete response (CR) plus the percentage of patients with documented partial response (PR). ORR will be reported with the corresponding exact confidence intervals.

Time frame
Time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first)

Secondary outcomes

1

Progression free survival (PFS)

Will be assessed using Kaplan-Meier estimates. PFS for the main cohorts (cohort 1 and cohort 2) and exploratory cohort (cohort 3) will be analyzed and reported separately.

Time frame
Time that elapses between the day of subject registration and the earlier of the day of first documented disease progression by clinical or radiographic evaluation or death from any cause, assessed up to 24 months
2

Overall survival (OS)

Will be assessed using Kaplan-Meier estimates. OS for the main cohort and exploratory cohort will be analyzed and reported separately.

Time frame
Time that elapses between the day of subject registration and death from any cause, assessed up to 24 months
3

Duration of response (DOR)

Will be assessed using Kaplan-Meier estimates. DOR for the main cohorts and exploratory cohort will be analyzed and reported separately.

Time frame
Time elapsed from the day when CR or PR is first observed until the earlier of the day of first documented disease progression or death, assessed up to 24 months
4

Incidence of adverse events

Will be assessed using the National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

Time frame
Up to 30 days post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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