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Phase I Dose Escalation Trial in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

Phase I Dose Escalation Trial in Patients With Advanced Solid Tumors

Inclusion Criteria


Inclusion criteria:

1. Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid
malignant tumours, who have failed conventional treatment or for whom no therapy of
proven efficacy exists or who are not amenable to established treatment options

2. Secure central venous access

3. Measurable and/or non-measurable tumour deposits

4. Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1

5. Age >= 18 years

6. Life expectancy >= 3 months

7. Written informed consent in accordance with International Conference on Harmonisation
guideline for Good Clinical Practice and local legislation

8. Eastern Cooperative Oncology Group performance score <= 2

Exclusion criteria:

1. Serious illness, concomitant non-oncological disease (e.g. active infectious
disease), or ongoing toxicity of prior therapies considered by the investigator to
potentially compromise patients' safety in this trial

2. Pregnancy or breastfeeding

3. Symptomatic brain metastases and/or leptomeningeal disease requiring therapy

4. Second malignancy requiring therapy

5. Left ventricular ejection fraction (LVEF) < 50% in echocardiography

6. Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (<= 6 months
prior to randomisation), myocardial infarction (<= 6 months prior to randomisation),
unstable angina, New York Heart Association Grade II or greater congestive heart
failure, or serious cardiac arrhythmia requiring medication

7. Absolute neutrophil count less than 1500 / mm3

8. Platelet count less than 100 000 / mm3

9. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent)

10. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater
than 2.5 times the upper limit of normal (if related to liver metastases greater than
five times the upper limit of normal)

11. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent)

12. Women and men who are sexually active and unwilling to use a medically acceptable
method of contraception

13. Treatment with other investigational drugs or in another clinical trial within the
past two weeks before start of therapy or concomitantly with this trial

14. Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of
therapy or concomitantly with this trial

15. Patients unable to comply with the protocol

16. Active alcohol or drug abuse

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

3-4 weeks

Safety Issue:

Yes

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

1257.1

NCT ID:

NCT00756223

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Neoplasms
  • Neoplasms

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