BN80927 in Patients With Advanced Malignant Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01435096
• Date of registration: 24/08/2011
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: BN80927 in Patients With Advanced Malignant Solid Tumors
• Scientific title: A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors
• Date of first enrolment: November 2004
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01435096
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Ipsen Study Director
• Affiliation: Ipsen

Key inclusion & exclusion criteria

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 ß-human-chorionic-gonadotrophin (ß-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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malignant Solid Tumour

Intervention(s)

Drug: BN80927

Primary Outcome(s)

Maximum tolerated dose determined by incidence of dose limiting toxicity. [Time Frame: During cycle 1, up to 3 weeks]

Recommended dose determined by incidence of dose limiting toxicity. [Time Frame: During cycle 1, up to 3 weeks]

Secondary Outcome(s)

Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria. [Time Frame: Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks)]

Tmax [Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)]

Area Under Curve [Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)]

Cmax [Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)]

Number of adverse events [Time Frame: Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.]

T1/2 [Time Frame: 72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)]

Secondary ID(s)

2-55-52905-701

2005-002703-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors