Study in Patients With SCLC of Veliparib in Combination With Topotecan

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central European Society for Anticancer Drug Research
• Treatments: Poly(ADP-ribose) Polymerase Inhibitors; Topotecan; Veliparib

Criteria

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