Study in Patients With SCLC of Veliparib in Combination With Topotecan
- Registration Number
- NCT03227016
- Lead Sponsor
- Central European Society for Anticancer Drug Research
- Brief Summary
Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan
- Detailed Description
For this study sensitive or refractory SCLC patients (refractory to prior chemotherapy defined as having experienced no response or a relapse within 90 days after the end of chemotherapy) will be eligible. In total, around 130 patients will be enrolled, around 30 evaluable patients in phase I and 100 patients in phase II.
The study will consist of two parts:
A preceding Phase I part will be performed to identify the Recommended Dose of veliparib to be administered in the Phase II part in combination with topotecan at the dose regimen of 1.25 mg/m2 (on days 1-5 of a 3 week cycle \[d1-5q21d\]). Each patient will be subjected to an initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in cycle shall prove topotecan tolerance of the candidates. Only patients who do not reveal any DLTs receive further treatment with combination therapy. In a dose-escalating 3+3 design the RD of veliparib for the subsequent Phase II part of the study will be defined during a maximum of 5 cycles combination therapy.
The Phase II part will follow upon completion of Phase I.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Topo/Veli veliparib Topotecan and Veliparib in increasing doses Combination Topo/Veli Topotecan Topotecan and Veliparib in increasing doses
- Primary Outcome Measures
Name Time Method adverse events 6 months adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinik München Gauting
🇩🇪München Gauting, Germany