BN80927 in Patients With Advanced Malignant Solid Tumors

Phase 1

Completed

• Conditions: Malignant Solid Tumour
• Interventions: Drug: BN80927

• Registration Number: NCT01435096
• Lead Sponsor: Ipsen

Brief Summary

The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BN80927	BN80927	-

Primary Outcome Measures

Name	Time	Method
Recommended dose determined by incidence of dose limiting toxicity.	During cycle 1, up to 3 weeks
Maximum tolerated dose determined by incidence of dose limiting toxicity.	During cycle 1, up to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.
Cmax	72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Area Under Curve	72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Tmax	72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)
Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.	Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks)
T1/2	72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days)

Trial Locations

Locations (3)

Centre Rene Huguenin; 🇫🇷 Saint-Cloud, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Eugene Marquis; 🇫🇷 Rennes, France