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Study in Patients With SCLC of Veliparib in Combination With Topotecan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03227016
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : January 27, 2021
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer SCLC Drug: veliparib Drug: Topotecan Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan
Actual Study Start Date : October 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Combination Topo/Veli
Topotecan and Veliparib in increasing doses
Drug: veliparib
Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.
Other Name: PARP inhibitor

Drug: Topotecan
Topotecan at dose 1.25 mg/m2 will be administered in each cycle.
Other Name: Hycamtin

Primary Outcome Measures :
  1. adverse events [ Time Frame: 6 months ]
    adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03227016

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Contact: Berta Moritz, PhD +431522309312

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Klinik München Gauting Recruiting
München Gauting, Germany
Contact: Joachim von Pawel, MD         
Sponsors and Collaborators
Central European Society for Anticancer Drug Research
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Study Chair: Joachim von Pawel, MD Askelios Klinik München Gauting
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Responsible Party: Central European Society for Anticancer Drug Research Identifier: NCT03227016    
Other Study ID Numbers: C-II-011
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Poly(ADP-ribose) Polymerase Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents