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A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Solid Tumour

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Trial Information

A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors


Inclusion Criteria:



All included patients:

- Gave their written (personally signed and dated) informed consent

- had histologically or cytologically documented malignant solid tumour

- had received no more than three prior chemotherapy regimens

- had failed the standard therapy or had no option of an active standard therapy

- had an estimated survival time of greater than 3 months (according to the
investigator's assessment)

- had a World Health Organisation (WHO) performance status score ≤1

- were free from other serious concurrent disease

- had adequate bone marrow function

- had adequate liver function

- had adequate renal function

- who were female and of child-bearing potential must have had a negative result in a
pre-study pregnancy test β-human-chorionic-gonadotrophin (β-HCG).

Exclusion Criteria:

No patient included:

- was pregnant or lactating

- was unable and/or unwilling to comply fully with the protocol and the study
instructions;

- presented with any concomitant condition, which could compromise the objectives of
the study

- had received an investigational drug within 30 days prior to study entry or was
scheduled to require concurrent treatment with an experimental drug or treatment
during the study

- had received chemotherapy or hormonotherapy within 4 weeks of study entry, or had
received chemotherapy with nitrosoureas or mitomycin-C within 6 weeks of study entry

- had received any extensive palliative or curative radiotherapy (no more than 35% of
their active bone marrow) within 2 weeks of study entry, or had not fully recovered
from such treatment

- had previously received a bone marrow transplant (BMT) or peripheral blood progenitor
cells (PBPC)

- had clinical evidence of major organ failure or brain metastases.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose determined by incidence of dose limiting toxicity.

Outcome Time Frame:

During cycle 1, up to 3 weeks

Safety Issue:

No

Principal Investigator

Ipsen Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2-55-52905-701

NCT ID:

NCT01435096

Start Date:

November 2004

Completion Date:

October 2007

Related Keywords:

  • Malignant Solid Tumour
  • Neoplasms

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