Study in Patients With SCLC of Veliparib in Combination With Topotecan

NCT03227016 | Unknown Phase 1 DMC

• 1 other identifier: C-II-011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small Cell Lung Cancer SCLC

Outcome Measures

Primary Outcomes (1)

• adverse events

  adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)

  6 months

Study Arms (1)

Combination Topo/Veli

EXPERIMENTAL

Topotecan and Veliparib in increasing doses

Drug: veliparib; Drug: Topotecan

Interventions

veliparib DRUG

Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.

Also known as: PARP inhibitor

Combination Topo/Veli

Topotecan DRUG

Topotecan at dose 1.25 mg/m2 will be administered in each cycle.

Also known as: Hycamtin

Combination Topo/Veli

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central European Society for Anticancer Drug Research: lead

Study Sites (1)

Klinik München Gauting

München Gauting, Germany

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

veliparib; Poly(ADP-ribose) Polymerase Inhibitors; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Joachim von Pawel, MD

  Askelios Klinik München Gauting

  STUDY CHAIR

Central Study Contacts

Berta Moritz, PhD

CONTACT

+431522309312; berta.moritz@cesar.or.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: July 24, 2017
• Study Start: October 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

DE (1)