A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion
Overview
- Phase
- Phase 1
- Intervention
- BB-10901
- Conditions
- Small Cell Lung Cancer
- Sponsor
- ImmunoGen, Inc.
- Enrollment
- 64
- Locations
- 11
- Primary Endpoint
- Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Detailed Description
The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BB-10901, 5mg/m2 - Phase I
Intervention: BB-10901
BB-10901, 10 mg/m2 - Phase I
Intervention: BB-10901
BB-10901, 20 mg/m2 - Phase I
Intervention: BB-10901
BB-10901, 40 mg/m2 - Phase I
Intervention: BB-10901
BB-10901, 60 mg/m2 - Phase I & Phase II
Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II.
Intervention: BB-10901
BB-10901, 67.5 mg/m2 - Phase I
Intervention: BB-10901
BB-10901, 75 mg/m2 - Phase I
Intervention: BB-10901
Outcomes
Primary Outcomes
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)
Time Frame: every 6 weeks
Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.
Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]
Time Frame: 6 weeks
Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions