A Phase I Study of High Dose Simvastatin in Patients With Gastrointestinal Tract Cancer Who Failed to Standard Chemotherapy

NCT03086291 | Unknown Phase 1 DMC

• 1 other identifier: 2017-02-138
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days Cohort 1: 7.5 mg/kg bid for 7 days 14 days off Cohort 2: 10 mg/kg bid for 7 days 14 days off Cohort 3: ( ) mg/kg bid for 7 days 14 days off (to be determined based on PK data of cohort 1 and 2) Q 3 weeks

Conditions

Stomach Cancer

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose

  maximum tolerated dose

  12months

Study Arms (1)

simvastatin

EXPERIMENTAL

One arm Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days Cohort 1: 7.5 mg/kg bid for 7 days 14 days off Cohort 2: 10 mg/kg bid for 7 days 14 days off Cohort 3: ( ) mg/kg bid for 7 days 14 days off (to be determined based on PK data of cohort 1 and 2) Q 3 weeks

Drug: Simvastatin

Interventions

Simvastatin DRUG

Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days

simvastatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial.
• Be 20 years of age on day of signing informed consent
• Have histologically or cytologically confirmed diagnosis of colorectal cancer or gastric cancer
• For colorectal cancer, patients who progressed after 5FU or capecitabine, irinotecan,oxaliplatin, bevacizumab and cetuximab treatment (cetuximab is only for KRAS/NRAS wild type)
• For gastric cancer, patients who progressed after second line chemotherapy.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Have evaluable disease based on RECIST v1.1 as determined by investigator.
• Be willing to provide blood sample for PK analysis.
• Ability to swallow and retain oral medication.
• Demonstrate adequate organ function

You may not qualify if:

• Prior history of statins within 12 months from the date of study entry
• Patients with massive ascites or disseminated bone metastases
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
• Patients with CPK \> ULN at baseline

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

wonki kang, ph.D

CONTACT

82-2-3410-3459; wonki.kang@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: January 4, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

KR (1)