A Phase I Study of ECO-4601 in Patients With Advanced Cancer

NCT00338026 | Completed Phase 1 DMC

• 1 other identifier: ECO-4601-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.

Conditions

Tumors; Glioma; Colorectal Cancer; Lung Cancer; Breast Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer

Keywords

Solid Tumors; Thallion; TLN-4601; Ecopia; ECO-4601; Patients with histologically confirmed solid tumors:; High Grade Glioma; Colorectal; Lung; Breast; Ovarian; Pancreatic; Prostate

Outcome Measures

Primary Outcomes (3)

• Safety/tolerability of ECO-4601

• Determination of MTD of ECO-4601

• Determination of recommended dose for future studies of ECO-4601

Secondary Outcomes (3)

• Pharmacokinetics of ECO-4601

• Safety of multiple cycles of administration of ECO-4601

• Documentation of ECO-4601 antitumor activity as per RECIST criteria

Study Arms (1)

ECO-4601

EXPERIMENTAL

Drug: ECO-4601

Interventions

ECO-4601 DRUG

Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)

Also known as: TLN-4601

ECO-4601

Eligibility Criteria

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

You may qualify if:

• Informed about the study and consent to participate in the study
• Clinically or radiologically documented advanced solid malignancy for which no standard therapy is available, or which has failed standard therapy
• Patients with the following solid tumors: high grade glioma, colorectal, prostate, pancreatic, lung, ovarian and breast carcinoma
• Age ≥ 18 years of age
• ECOG ≤ 2
• Laboratory hematology and biochemistry protocol test result abnormalities ≤ Grade 1, graded using NCI CTCAE version 3.0
• Patients with no chemotherapy during the 4 weeks preceding patients' first dose of ECO-4601 (day 1, cycle 1)
• No other anticancer treatment during the study
• Patients can be receiving stable or decreasing dose of steroids within 2 weeks prior to patient's signature of the informed consent
• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
• Previous Therapy
• Hormonal therapy: Patients may have had prior hormonal therapy provided it is discontinued upon ICF signature
• Radiation: Patients may have had prior radiation therapy. Patients must have recovered from the acute toxic effects of radiotherapy
• Previous surgery: Previous surgery is permitted provided that at least 2 weeks have elapsed between major surgery (non-biopsy) and ICF signature

You may not qualify if:

• Patients with brain metastases
• Unlikely to comply with protocol or difficulty to understand the purpose of the study
• Life expectancy \< 12 weeks
• Clinically significant co-morbid disease, e.g. renal failure, ischemic vascular disease, uncontrolled seizure, dementia
• Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
• Anti seizure drugs known inducers of cytochrome P450
• Documented HIV, active hepatitis B or C infections
• Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
• Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
• Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years
• Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
• Patients in whom a proper central line cannot be established
• Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
• Patients on low molecular weight heparin for \< 2 weeks prior to ICF signature
• Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded

Sponsors & Collaborators

• Thallion Pharmaceuticals: lead

Study Sites (2)

Hôpital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Neoplasms; Glioma; Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms

Interventions

diazepinomicin

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Petr Kavan, MD, Ph.D.

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Benoît Samson, MD

  Hopital Charles Lemoyne

  PRINCIPAL INVESTIGATOR

• Gerald Batist, MD

  Sir Mortimer B. Davis - Jewish General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 15, 2008

Record last verified: 2008-07

Locations

CA (2)