NCT00345189

Brief Summary

This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2006

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 14, 2009

Status Verified

July 1, 2009

Enrollment Period

2.4 years

First QC Date

June 23, 2006

Last Update Submit

July 10, 2009

Conditions

TumorsLymphoma

Keywords

Hsp90 inhibitorCNF2024Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

  • To determine the maximum tolerated dose (MTD)

    Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.

  • To determine the safety profile

    Study duration

  • pharmacokinetic profile

    Dosing period

  • effect on pharmacodynamic biomarkers

    Dosing period

  • antitumor activity

    At screening and after every 2 courses

Study Arms (2)

Dosing Schedule 1

OTHER

Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed.

Drug: CNF2024

Dosing Schedule 2

OTHER

Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).

Drug: CNF2024

Interventions

CNF2024DRUG

CNF2024 capsules administered orally following 2 schedules: * starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or * starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment.

Also known as: Advanced Solid Tumors
Dosing Schedule 1Dosing Schedule 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed solid tumor which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available
  • At least 18 years of age
  • Hematology: Absolute neutrophil count (ANC) \> 1500 cells/mm3, platelet count \> 100,000 cells/mm3 and hemoglobin \>= 9 gm/L
  • Hepatic: Bilirubin \< 1.5 X upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5.0 X ULN.
  • Renal: Serum creatinine levels \< 2.0 mg/dL or creatinine clearance \> 60 mL/min
  • Coagulation: international normalized ratio (INR) \< 1.5 times normal
  • Adrenal: Normal plasma cortisol and adrenocorticotropic hormone (ACTH) levels
  • Normal electrocardiogram (ECG) with QTc \<= 450 msec for men and \<= 470 msec for women
  • Estimated life expectancy of at least 3 months as determined by the Investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
  • Male and female patients of childbearing potential must practice effective double-barrier contraception during the study and continue contraception for 3 months after their last dose of study drug. Male patients must agree to not have intercourse with pregnant or nursing women during the study and for 3 months after their last dose of study drug, unless using double-barrier contraception. The only exceptions to double-barrier contraception are: Patient or partner is surgically sterile,female patient is postmenopausal for at least 1 year before screening or patient abstains from sexual intercourse, at the discretion of the Investigator

You may not qualify if:

  • Pregnant or nursing women, women of child-bearing age not using reliable means of contraception.
  • Radiotherapy or chemotherapy within the previous 28 days. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required.
  • Participation in any investigational drug study within 28 days prior to CNF2024 administration
  • Active infection requiring intravenous antibiotic treatment
  • Patients with second malignancy requiring active treatment (except hormonal therapy)
  • Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure)
  • Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis
  • Problems with swallowing or malabsorption
  • Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
  • Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
  • Major surgery of the stomach or small intestine
  • Adrenal dysfunction \> Grade 2
  • Patients with diabetes (your doctor will discuss if you are eligible for this study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research site

Scottsdale, Arizona, 85258, United States

Location

Research site

New Haven, Connecticut, 06520, United States

Location

Research site

San Antonio, Texas, 78245, United States

Location

Research site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

NeoplasmsLymphoma

Interventions

6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Biogen Idec Medical Monitor, MD

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2008

Study Completion

April 1, 2009

Last Updated

July 14, 2009

Record last verified: 2009-07

Locations

GB(1)US(3)