Small Cell Lung Cancer SCLCPhase 1NCT03227016
Study in Patients With SCLC of Veliparib in Combination With Topotecan
A Phase 1 study testing veliparib and Topotecan in people with Small Cell Lung Cancer SCLC, run by Central European Society for Anticancer Drug Research at 1 site in Germany.
Trial summary
Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Small Cell Lung Cancer SCLC
- What is being tested?
- veliparib and Topotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik München Gauting
München Gauting
Joachim von Pawel, MD
About this study
Official title: Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan
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.
- Conditions
- Small Cell Lung Cancer SCLC
- Being tested
- veliparib, Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veliparibDrug
Also called PARP inhibitor
Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.
TopotecanDrug
Also called Hycamtin
Topotecan at dose 1.25 mg/m2 will be administered in each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Combination Topo/Veli | Experimental | Topotecan and Veliparib in increasing doses Receives: Drug: veliparib; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startOct 2016
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer SCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central European Society for Anticancer Drug Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim von Pawel, MD, Study chair, Askelios Klinik München Gauting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227016
- Sponsor's protocol ID
- C-II-011
- Status last verified
- Jan 2021
- First submitted
- 1 Aug 2016
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan
- ClinicalTrials.gov ID
- NCT03227016
- Acronym / sponsor ID
- C-II-011
- Conditions
- Small Cell Lung Cancer SCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central European Society for Anticancer Drug ResearchUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Topo/Veli | Experimental | Drug: veliparib, Drug: TopotecanTopotecan and Veliparib in increasing doses |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| veliparibAlso: PARP inhibitorTopotecan at increasing doses (1x or 2x per day) will be administered in each cycle. | Drug | Combination Topo/Veli |
| TopotecanAlso: HycamtinTopotecan at dose 1.25 mg/m2 will be administered in each cycle. | Drug | Combination Topo/Veli |
Primary outcome
adverse events
Time frame: 6 months
adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Related trials for Small Cell Lung Cancer SCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim von Pawel, MD study chair
Askelios Klinik München Gauting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing veliparib and Topotecan in people with Small Cell Lung Cancer SCLC, run by Central European Society for Anticancer Drug Research at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berta Moritz, PhD (+431522309312, berta.moritz@cesar.or.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.