Study in Patients With SCLC of Veliparib in Combination With Topotecan

Sponsor

Central European Society for Anticancer Drug Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT03227016

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2016

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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

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 Names:

PARP inhibitor

Drug: Topotecan

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

Other Names:

Hycamtin

Outcome Measures

Primary Outcome Measures

adverse events [6 months]
adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik München Gauting	München Gauting		Germany

Sponsors and Collaborators

Central European Society for Anticancer Drug Research

Investigators

Study Chair: Joachim von Pawel, MD, Askelios Klinik München Gauting

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central European Society for Anticancer Drug Research

ClinicalTrials.gov Identifier:

NCT03227016

Other Study ID Numbers:

C-II-011

First Posted:

Jul 24, 2017

Last Update Posted:

Jan 27, 2021

Last Verified:

Jan 1, 2021

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.:

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Topotecan

Veliparib

Poly(ADP-ribose) Polymerase Inhibitors

Study Results

No Results Posted as of Jan 27, 2021