CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
BB-10901drug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically or cytologically confirmed SCLC, CD56+ small cell carcinoma of unknown origin, or CD56+ non-pulmonary small cell carcinoma
  • ✓Relapsed disease with initial response to first-line therapy and relapse >3 months after last chemotherapy
  • ✓No more than 3 prior chemotherapy regimens
  • ✓Measurable disease per RECIST in at least one dimension
Key exclusion· 10
  • ✕Grade 3-4 residual neurological or cardiac toxicity from prior chemotherapy
  • ✕Concurrent anti-neoplastic treatment (chemotherapy, radiotherapy, immunotherapy, or steroid therapy)
  • ✕Myocardial infarction within 6 months, unstable angina, uncontrolled CHF, arrhythmia, severe aortic stenosis
  • ✕History of multiple sclerosis or other demyelinating disease, Eaton-Lambert Syndrome, hemorrhagic or ischemic stroke within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00065429
NCT00065429Phase 2Completed
CompareCT.gov

A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion

ImmunoGen, Inc.·interventional·Posted Jul 24, 2003·Updated Jul 18, 2012

In Brief

A Phase 2 clinical trial evaluating BB-10901 for Small Cell Lung Cancer. Completed, enrolled 64 participants across 11 sites.

Detailed Summary

This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 24, 2003
Enrollment StartApr 1, 2003
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 22.9 years ago

Interventions

BB-10901drug

I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.