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Study in Patients With SCLC of Veliparib in Combination With Topotecan

Primary Purpose

Small Cell Lung Cancer SCLC

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

veliparib

Topotecan

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer SCLC

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik München GautingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Topo/Veli

Arm Description

Topotecan and Veliparib in increasing doses

Outcomes

Primary Outcome Measures

adverse events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03227016

First Posted

August 1, 2016

Last Updated

January 26, 2021

Sponsor

Central European Society for Anticancer Drug Research

1. Study Identification

Unique Protocol Identification Number

NCT03227016

Brief Title

Study in Patients With SCLC of Veliparib in Combination With Topotecan

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (Actual)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central European Society for Anticancer Drug Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer SCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination Topo/Veli

Arm Type

Experimental

Arm Description

Topotecan and Veliparib in increasing doses

Intervention Type

Drug

Intervention Name(s)

veliparib

Other Intervention Name(s)

PARP inhibitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Topotecan

Other Intervention Name(s)

Hycamtin

Intervention Description

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

Primary Outcome Measure Information:

Title

adverse events

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Berta Moritz, PhD

Phone

+431522309312

berta.moritz@cesar.or.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joachim von Pawel, MD

Organizational Affiliation

Askelios Klinik München Gauting

Official's Role

Study Chair

Facility Information:

Facility Name

Klinik München Gauting

City

München Gauting

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joachim von Pawel, MD

12. IPD Sharing Statement

Learn more about this trial

Study in Patients With SCLC of Veliparib in Combination With Topotecan

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