Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Lorvotuzumab mertansine

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II.

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

BB-10901

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.

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).

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

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

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 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

ImmunoGen, Inc.

IMGN 5 mg/m2

IMGN 10 mg/m2

IMGN 20 mg/m2

IMGN 40 mg/m2

IMGN 60 mg/m2

IMGN 67.5 mg/m2

IMGN 75 mg/m2

Total

Age Continuous

>=18 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

CMO, ImmunoGen

Non-infective meningitis

Hyperesthesia Grade 4

Peripheral sensory neuropathy Grade 3

Fatigue Grade 3

Headache Grade 3

The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.

Phase I

All Phase I enrolled patients who received study drug were analyzed for DLTs.

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

Complete Response (CR) or Partial Response (PR)

Stable Disease

Progressive Disease (PD)

Unknown

For Phase II, the planned design was to use a Gehan's two-stage design \[4\], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.

Phase II

All patients with a baseline and follow up imaging scan were evaluated. Data represents information following the first cycle of treatment.

Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]

Phase I - May 2001 - Oct 2002

Phase II - Apr 2003 - Aug 2008

Spots Global Cancer Trial Database for Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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