Phase 2
Completed N=23
BI 2536 Second Line Monotherapy in SCLC
Carcinoma, Small Cell
Source: ClinicalTrials.gov NCT00412880 ↗
Enrolled (actual)
23
Serious AEs
21.7%
Results posted
May 2022
Primary outcomePrimary: Number of Participants With Objective Tumor Response — 0; 0 Participants
Summary
Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Tumor Response |
0; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
43 | — |
| SECONDARY Overall Survival |
5 | — |
| SECONDARY Duration of Overall Response |
— | — |
| SECONDARY Occurrence and Intensity of Adverse Events Graded According to CTCAE |
1; 4; 8; 6; 2 | — |
| SECONDARY Number of Participants With Dose Limiting Toxicity |
4 | — |
| SECONDARY Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures |
3; 4; 6; 1; 9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
- Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
- Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.
Exclusion Criteria
- More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
- Symptomatic brain metastases or leptomeningeal disease
- Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
- Absolute neutrophil count (ANC) 1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)
- Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug
- Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
- Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
- Known or suspected active drug or alcohol abuse
- Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
- Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
- Patients with neuropathy (sensory or motor) CTCAE 3
Data sourced from ClinicalTrials.gov (NCT00412880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.