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COAST Therapy in Advanced Solid Tumors and Prostate Cancer

ConditionsProstate Cancer RecurrentSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

The purpose of this Phase I/II study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of solid tumor cancers. The drugs are hydroxychloroquine, metformin, sirolimus, dasatinib and nelfinavir and are given orally.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng/mL.

Tissue diagnosis documented by pathology report, or clinic note attesting to same.

Measurable / evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging

Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.

Disqualifiers

New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on ECG.

Underlying psychiatric disorder requiring hospitalization within the last two years.

Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.

Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Hydroxychloroquine, Metformin, Sirolimus

    Combination product

    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily

  • Hydroxychloroquine, Metformin, Sirolimus, Dasatanib

    Combination product

    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily

  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir

    Combination product

    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily

  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib

    Combination product

    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily Dasatanib 20mg daily

  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir

    Combination product

    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily

  • Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib

    Combination product

    Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily Dasatanib 20mg daily

Treatment groups

76 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Dose level 1Experimental treatment 1 intervention
Group B: Dose level 2aExperimental treatment 1 intervention
Group C: Dose level 2bExperimental treatment 1 intervention
Group D: Dose level 3aExperimental treatment 1 intervention
Group E: Dose level 3bExperimental treatment 1 intervention
Group F: Dose level 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD) - Phase I

Maximum dose achievable without dose limiting toxicities (DLT's)

Time frame
Minimum of 3 months after start of treatment on each dose level
2

Measure of proportion of patients with disease control - Phase II

Stable disease by RECIST or PCWG3 criteria after 16 weeks of treatment on study.

Time frame
Minimum of 16 weeks after start of treatment, per patient

Secondary outcomes

1

Change in Quality of Life (QOL) score

To document the change in QOL (via disease-specific FACT questionnaire, composite score) in patients treated with COAST) after two and four cycles of treatment

Time frame
Minimum of 16 weeks of treatment on study

Other outcomes

Sponsors and contacts

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

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov
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