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Status unknownNCT03227016Updated Jan 27, 2021

Study in Patients With SCLC of Veliparib in Combination With Topotecan

A Phase 1 interventional study of veliparib and Topotecan in Small Cell Lung Cancer SCLC, sponsored by Central European Society for Anticancer Drug Research. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Central European Society for Anticancer Drug Research · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Small Cell Lung Cancer SCLC
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Central European Society for Anticancer Drug Research is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Combination Topo/Veli

    Topotecan and Veliparib in increasing doses

    Drug: veliparib · Drug: Topotecan

Interventions

  • Drugveliparib

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

    Also known as: PARP inhibitor

  • DrugTopotecan

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

    Also known as: Hycamtin

06

What researchers measure

Primary outcomes

  1. adverse events

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Klinik München Gauting
    München Gauting, Germany
    • Joachim von Pawel, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03227016
Lead sponsor
Central European Society for Anticancer Drug Research
Responsible party
Sponsor
First posted
Jul 24, 2017
Start date
Oct 2016
Primary completion
May 2021 (estimated)
Completion
Jun 2021 (estimated)
Last update
Jan 27, 2021

Study contacts

Berta Moritz, PhD
Contact
berta.moritz@cesar.or.at
+431522309312
Joachim von Pawel, MD
study chair · Askelios Klinik München Gauting

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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