Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: BB-10901

• Registration Number: NCT00065429
• Lead Sponsor: ImmunoGen, Inc.

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).

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-07-23
• Study First Submitted QC: 2003-07-23
• Study First Posted: 2003-07-24
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Results First Submitted: 2011-08-03
• Results First Submitted QC: 2012-05-17
• Results First Posted: 2012-06-20
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BB-10901, 10 mg/m2 - Phase I	BB-10901	-
BB-10901, 5mg/m2 - Phase I	BB-10901	-
BB-10901, 20 mg/m2 - Phase I	BB-10901	-
BB-10901, 40 mg/m2 - Phase I	BB-10901	-
BB-10901, 60 mg/m2 - Phase I & Phase II	BB-10901	Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II.
BB-10901, 67.5 mg/m2 - Phase I	BB-10901	-
BB-10901, 75 mg/m2 - Phase I	BB-10901	-

Primary Outcome Measures

Name	Time	Method
Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)	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]	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

Trial Locations

Locations (11)

Greater Dayton Cancer Center; 🇺🇸 Kettering, Ohio, United States

The Ohio State University; 🇺🇸 Colombus, Ohio, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

Tyler Cancer Center; 🇺🇸 Tyler, Texas, United States

New York Oncology Hematology; 🇺🇸 Albany, New York, United States

Cancer Center of Florida; 🇺🇸 Ocoee, Florida, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Cancer Centers of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Northwest Cancer Specialists; 🇺🇸 Vancouver, Washington, United States