Relapsed Small Cell Lung CancerPhase 1/2NCT04543916
Venetoclax and Irinotecan in Relapsed/Refractory SCLC
A Phase 1/2 study testing Venetoclax 50 MG, Venetoclax 100 MG and Venetoclax 200 MG in people with Relapsed Small Cell Lung Cancer and Refractory Small Cell Lung Carcinoma, run by Virginia Commonwealth University.
Trial summary
This study is a single-arm, open-label, multicenter phase 1/2 trial designed to establish the recommended phase 2 dose (RP2D) of daily oral venetoclax when given in combination with irinotecan in patients with relapsed or refractory small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Small Cell Lung Cancer, Refractory Small Cell Lung Carcinoma
- What is being tested?
- Venetoclax 50 MG, Venetoclax 100 MG and Venetoclax 200 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 30 Jun 2028
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of SCLC
- Disease progression or recurrence during or after platinum-based therapy, unless platinum-based therapy was contraindicated
- Phase 1: Measurable or evaluable disease according to RECIST v1.1
- Phase 2: Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years
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- Adequate bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 8.0 g/dL
- Adequate renal function as defined below:
- Serum creatinine ≤ upper limit of normal (ULN) for the lab or a calculated creatinine clearance ≥ 40 mL/min
- Adequate hepatic function as defined below:
- Total bilirubin ≤ 1.5 x ULN for the laboratory
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN for the laboratory
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN for the laboratory
- Persons with known HIV seropositivity are eligible if they meet the following criteria:
- CD4 count ≥ 200/mm3
- Undetectable HIV viral load on standard PCR-based test
- On a stable regimen of highly active anti-retroviral therapy (HAART) that does not include protocol contraindicated agents
- No ongoing requirement for concurrent antibiotics or antifungal agents for the prevention of HIV-associated opportunistic infections
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Ongoing requirement for any non-study anticancer therapy
- Ongoing or planned treatment with any of the following:
- Greater than 10 mg prednisone daily or equivalent
- Immunosuppressive agents
- Strong or moderate CYP3A inhibitor or inducer, or a narrow-therapeutic sensitive substrate
- P-gp inhibitor or narrow-therapeutic sensitive P-gp substrate If any of these agents have been used, patients must be off them for ≥ 1 week before initiation of study treatment.
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- Any investigational agent within 21 days prior to the first dose of the investigational drugs
- Has consumed grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before initiation of study treatment.
- Phase 2 portion only: Previous systemic anticancer therapy other than platinum-based therapy
- Known leptomeningeal metastases
- Known untreated brain metastases
- Hypersensitivity to irinotecan, venetoclax, or their excipients
- Diarrhea ≥ grade 1
- Ongoing need for antidiarrheal agents
- Active uncontrolled infection, ongoing or within 2 weeks before initiating treatment
- Known homozygosity for the UGT1A1*28 allele Note: Study-specific UGT1A1 testing is not required
- Inability to swallow oral medications and/or malabsorption
- Pregnancy or breastfeeding
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
About this study
Official title: A Phase 1/2 Study of Venetoclax and Irinotecan in Relapsed/Refractory Small Cell Lung Cancer
This study is a single-arm, open-label, multicenter phase 1/2 trial designed to establish the recommended phase 2 dose (RP2D) of daily oral venetoclax when given in combination with irinotecan in patients with relapsed or refractory small cell lung cancer (SCLC).
Read the detailed description
Irinotecan will be given at 60 mg/m2 on days 1, 8, and 15 of each 28-day cycle. A 3+3 dose escalation design will be followed until the maximum tolerated dose (MTD) of venetoclax has been determined. Once the MTD is established, a RP2D that is the same as or less than the MTD will be determined. If no RP2D can be determined, the study will close to accrual. The RP2D will be used in an expansion cohort based on a Simon's two-stage minimax design to evaluate efficacy.
- Being tested
- Venetoclax 50 MG, Venetoclax 100 MG, Venetoclax 200 MG, Venetoclax 400, Venetoclax 600
- Keywords
- Relapsed SCLC, Refractory SCLC
- 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.
Venetoclax 50 MGDrug
Escalating doses to determine recommended phase 2 dose (RP2D)
Venetoclax 100 MGDrug
Escalating doses to determine recommended phase 2 dose (RP2D)
Venetoclax 200 MGDrug
Escalating doses to determine recommended phase 2 dose (RP2D)
Venetoclax 400Drug
Escalating doses to determine recommended phase 2 dose (RP2D)
Venetoclax 600Drug
Escalating doses to determine recommended phase 2 dose (RP2D)
Irinotecan 60 mg/m2Drug
Intravenously (IV), days 1, 8, and 15
Venetoclax (RP2D)Drug
orally, once per day
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Venetoclax 50mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 Receives: Drug: Venetoclax 50 MG; Drug: Irinotecan 60 mg/m2 |
| Dose Level 2 | Experimental | Venetoclax 100mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 Receives: Drug: Venetoclax 100 MG; Drug: Irinotecan 60 mg/m2 |
| Dose Level 3 | Experimental | Venetoclax 200mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 Receives: Drug: Venetoclax 200 MG; Drug: Irinotecan 60 mg/m2 |
| Dose Level 4 | Experimental | Venetoclax 400mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 Receives: Drug: Venetoclax 400; Drug: Irinotecan 60 mg/m2 |
| Dose Level 5 | Experimental | Venetoclax 600mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 Receives: Drug: Venetoclax 600; Drug: Irinotecan 60 mg/m2 |
| Phase 2 Expansion Cohort | Experimental | Venetoclax recommended phase 2 dose (RP2D) by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 Receives: Drug: Irinotecan 60 mg/m2; Drug: Venetoclax (RP2D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Determine the recommended phase 2 dose (RP2D) of venetoclax with irinotecan in patients with relapsed or refractory SCLC
Recommended phase 2 dose (RP2D) of venetoclax in combination with irinotecan that is less than or equal to the maximum tolerated dose (MTD). A 3+3 dose escalation design will be followed until the maximum tolerated dose (MTD) of venetoclax has been determined. Patients assigned to a dose level of venetoclax greater than 50 mg will undergo a ramp-up phase during the first week of irinotecan
Measured: 90 Days
Phase 2: Evaluate the efficacy of venetoclax with irinotecan in patients with relapsed or refractory SCLC
The RP2D will be used in an expansion cohort based on a Simon's two-stage minimax design to evaluate efficacy.
Measured: 180 Days
Secondary outcomes (3)
Assess the frequency of adverse events (AEs)
Assess adverse events (AEs) characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V 5.0) to determine safety and toxicity of the combination of venetoclax and irinotecan.
Measured: 120 Days
Evaluate the antitumor effects of venetoclax and irinotecan in combination.
Evaluate the anti tumor effects of tumor response based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Measured: 180 Days
Observe survival in relapsed or refractory SCLC patients receiving venetoclax in combination with irinotecan
Progression-free survival and overall survival of patients with relapsed or refractory SCLC receiving venetoclax in combination with irinotecan
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start30 Jun 2021 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: AbbVie decided to stop trial involving Venetoclax for safety measures needed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation will proceed within each cohort. Phase II is the expansion cohort at the recommended phase 2 dose found in phase 1
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Sosipatros Boikos, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543916
- Sponsor's protocol ID
- MCC-17-13842
- Other IDs
- HM20019851
- Status last verified
- Mar 2021
- First submitted
- 2 Sep 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Venetoclax and Irinotecan in Relapsed/Refractory Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04543916
- Acronym / sponsor ID
- MCC-17-13842
- Keywords
- Relapsed SCLC, Refractory SCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: AbbVie decided to stop trial involving Venetoclax for safety measures needed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Sep 2020 (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.
This study is a single-arm, open-label, multicenter phase 1/2 trial designed to establish the recommended phase 2 dose (RP2D) of daily oral venetoclax when given in combination with irinotecan in patients with relapsed or refractory small cell lung cancer (SCLC).
Detailed description
Irinotecan will be given at 60 mg/m2 on days 1, 8, and 15 of each 28-day cycle. A 3+3 dose escalation design will be followed until the maximum tolerated dose (MTD) of venetoclax has been determined. Once the MTD is established, a RP2D that is the same as or less than the MTD will be determined. If no RP2D can be determined, the study will close to accrual. The RP2D will be used in an expansion cohort based on a Simon's two-stage minimax design to evaluate efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Dose escalation will proceed within each cohort. Phase II is the expansion cohort at the recommended phase 2 dose found in phase 1
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: Venetoclax 50 MG, Drug: Irinotecan 60 mg/m2Venetoclax 50mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 |
| Dose Level 2 | Experimental | Drug: Venetoclax 100 MG, Drug: Irinotecan 60 mg/m2Venetoclax 100mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 |
| Dose Level 3 | Experimental | Drug: Venetoclax 200 MG, Drug: Irinotecan 60 mg/m2Venetoclax 200mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 |
| Dose Level 4 | Experimental | Drug: Venetoclax 400, Drug: Irinotecan 60 mg/m2Venetoclax 400mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 |
| Dose Level 5 | Experimental | Drug: Venetoclax 600, Drug: Irinotecan 60 mg/m2Venetoclax 600mg by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 |
| Phase 2 Expansion Cohort | Experimental | Drug: Irinotecan 60 mg/m2, Drug: Venetoclax (RP2D)Venetoclax recommended phase 2 dose (RP2D) by mouth once daily and Irinotecan 60 mg/m2 intravenously (IV) on days 1, 8, and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histological or cytological diagnosis of SCLC
- Disease progression or recurrence during or after platinum-based therapy, unless platinum-based therapy was contraindicated
- Phase 1: Measurable or evaluable disease according to RECIST v1.1
- Phase 2: Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (19 listed)
- Ongoing requirement for any non-study anticancer therapy
- Ongoing or planned treatment with any of the following:
- Any investigational agent within 21 days prior to the first dose of the investigational drugs
- Has consumed grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before initiation of study treatment.
- Phase 2 portion only: Previous systemic anticancer therapy other than platinum-based therapy
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 |
|---|---|---|
| Venetoclax 50 MGEscalating doses to determine recommended phase 2 dose (RP2D) | Drug | Dose Level 1 |
| Venetoclax 100 MGEscalating doses to determine recommended phase 2 dose (RP2D) | Drug | Dose Level 2 |
| Venetoclax 200 MGEscalating doses to determine recommended phase 2 dose (RP2D) | Drug | Dose Level 3 |
| Venetoclax 400Escalating doses to determine recommended phase 2 dose (RP2D) | Drug | Dose Level 4 |
| Venetoclax 600Escalating doses to determine recommended phase 2 dose (RP2D) | Drug | Dose Level 5 |
| Irinotecan 60 mg/m2Intravenously (IV), days 1, 8, and 15 | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Phase 2 Expansion Cohort |
| Venetoclax (RP2D)orally, once per day | Drug | Phase 2 Expansion Cohort |
Primary outcome
Phase 1: Determine the recommended phase 2 dose (RP2D) of venetoclax with irinotecan in patients with relapsed or refractory SCLC
Time frame: 90 Days
Recommended phase 2 dose (RP2D) of venetoclax in combination with irinotecan that is less than or equal to the maximum tolerated dose (MTD). A 3+3 dose escalation design will be followed until the maximum tolerated dose (MTD) of venetoclax has been determined. Patients assigned to a dose level of venetoclax greater than 50 mg will undergo a ramp-up phase during the first week of irinotecan
Phase 2: Evaluate the efficacy of venetoclax with irinotecan in patients with relapsed or refractory SCLC
Time frame: 180 Days
The RP2D will be used in an expansion cohort based on a Simon's two-stage minimax design to evaluate efficacy.
3 secondary outcomes
Assess the frequency of adverse events (AEs)
Time frame: 120 Days
Evaluate the antitumor effects of venetoclax and irinotecan in combination.
Time frame: 180 Days
Observe survival in relapsed or refractory SCLC patients receiving venetoclax in combination with irinotecan
Time frame: 180 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
Sosipatros Boikos, MD principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Venetoclax 50 MG, Venetoclax 100 MG and Venetoclax 200 MG in people with Relapsed Small Cell Lung Cancer and Refractory Small Cell Lung Carcinoma, run by Virginia Commonwealth University.
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 22 inclusion and 19 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: withdrawn, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Determine the recommended phase 2 dose (RP2D) of venetoclax with irinotecan in patients with relapsed or refractory SCLC (time frame: 90 Days). The study lists 2 primary outcomes in all. 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 3 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.