| Eligibility |
Inclusion Criteria:
- Subject must be = 18 years of age
- Subject with progressive or recurrent ED-SCLC after first line platinum-based therapy,
which is either histologically or cytologically confirmed
- Performance status (PS) 0-2 ECOG
- Adequate bone marrow reserve
- Total bilirubin < 2 x upper limit of normal
- AST and ALT < 2.5 x upper limit of normal, or < 5 x upper limit of normal in case of
liver metastases
- Serum creatinine < 2 x upper limit of normal or creatinine clearance > 50 ml/min
Exclusion Criteria:
- Other anti-cancer chemotherapy or radiotherapy
- Symptomatic motor or sensory neuro-toxicities CTCAE > Grade 2 or any other unresolved
toxicities from prior systemic anti-cancer therapy or radiotherapy CTCAE > Grade 1
- Known hypersensitivity to topotecan or veliparib
- Brain or meningeal metastasis (unless they are asymptomatic and not requiring systemic
corticosteroid therapy)
- Major surgery within 6 weeks prior to first treatment on study (subjects must have
completely recovered from any previous surgery prior to first treatment on study).
- History of cardiac events within the past 3 months
- Uncontrolled severe hypertension
- Abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or
intra-abdominal abscess
- Uncontrolled nausea / vomiting / diarrhea
- Previous malignancy (other than SCLC) in the last 3 years, except basal cell cancer of
the skin, pre-invasive cancer of the cervix, T1a prostate carcinoma or superficial
bladder tumor [Ta, Tis and T1] that was cured in the opinion of the investigator.
- History of organ allograft
- Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral
genesis
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