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Small Cell Lung CarcinomaPhase 1NCT03850067

A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer

A Phase 1 study testing CC-90011, Cisplatin and Carboplatin in people with Small Cell Lung Carcinoma, run by Celgene at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
CC-90011, Cisplatin and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
13 sitesin 3 countries
Study dates
12 Mar 2019to 16 Jul 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subject is 18 years of age or older at the time of signing the informed consent form (ICF).
  • Subject with histological or cytological confirmation of extensive stage SCLC according to 2015 WHO classification (Travis, 2015).
  • Subject must be able to provide fresh or archival tumor tissues
  • Subject is found suitable for at least 4 cycles of platinum-based standard chemotherapy.
  • Subject has at least 1 site of measurable disease per RECIST 1.1.
  • Subject must have the following laboratory values:
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  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Hemoglobin (Hgb) ≥ 10 g/dL (≥ 100 g/L or > 6.2 mmol/L)
  • Platelet count (Plt) ≥ 150 x 109/L
  • Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver metastases are present
  • Serum total bilirubin ≤ 1.5 x ULN
  • Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min (see Appendix G to see creatinine clearance formula). For the purposes of this protocol, the glomerular filtration rate (GFR) is considered to be equivalent to the creatinine clearance.
  • Prothrombin time (or international normalized ratio [INR]) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN
  • Females of childbearing potential (FCBP) must:
  • Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use one highly effective contraceptive method plus one barrier method.
  • Have two negative pregnancy tests as verified by the Investigator prior to starting CC-90011:
  • a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at Screening
  • a negative serum or urine pregnancy test within 24 hours prior to Cycle 1 Day 1 of study treatment.
  • a negative Serum or urine within 24 hours prior to first dose of nivolumab and then every 4 weeks (± 1 week) regardless of dosing schedule.
  • Avoid conceiving for 6 months after last dose of cisplatin or carboplatin or etoposide, or 5 months after last dose of nivolumab for FCBP, or 45 days after the last dose of CC-90011, whichever is the latest.
  • Agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
  • Males must practice true abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or an FCBP and will avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for 6 months after last dose of cisplatin, or carboplatin, or etoposide or at least 105 days following CC-90011 discontinuation, whichever is the latest, even if he has undergone a successful vasectomy.
  • Males must agree to refrain from donating sperm while on treatment and females must agree to refrain from donating ova while on treatment and for 6 months after the last dose of cisplatin or etoposide or 105 days after last dose of CC-90011.
  • Subject is able to swallow pills.

Who cannot join

  • Subject has received anticancer therapy (either approved or investigational, including radiation with curative intent) for SCLC prior to study entry.
  • Subject has undergone major surgery ≤ 4 weeks prior to Cycle 1 Day 1 or has not recovered from surgery.
  • Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management), or any other significant gastrointestinal (GI) disorder that could affect the absorption of CC- 90011.
  • Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
  • Subject with any hemorrhage/bleeding event > CTCAE Grade 2 or hemoptysis > 1 teaspoon within 4 weeks prior to the first dose.
  • Subject with symptomatic and untreated or unstable central nervous system (CNS) metastases.
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  • Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).
  • Complete left bundle branch or bifascicular block.
  • Congenital long QT syndrome.
  • Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation.
  • QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings).
  • Subject has other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg).
  • Subject is a pregnant or nursing female.
  • Subject has known human immunodeficiency virus (HIV) infection.
  • Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection.
  • Subject with ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonist).
  • Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment.
  • Subject has Grade 2 peripheral sensory neuropathy.
  • Subject with poor bone marrow reserve as assessed by Investigator.
  • Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1.
  • Acute symptoms must have resolved and based on investigator assessment in consultation with the medical monitor, there are no sequelae that would place the participant at a higher risk of receiving study treatment
  • Previous SARS-CoV-2 vaccine within 7 days of C1D1. For vaccines requiring more than one dose, the full series (e.g. both doses of a two-dose series) should be completed prior to C1D1 when feasible and when a delay in C1D1 would not put the study subject at risk
  • Subject has any condition that confounds the ability to interpret data from the study.
  • For the subjects treated with nivolumab:
  • Subject has received prior therapies targeting PD-1 or PD-L1
  • Subject has a history of persistent skin rash ≥ NCI CTCAE Grade 2.
  • Subject with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids within 14 days (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Subjects with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • 22. Subject has received treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks prior to randomization. Refer to Section 8.2 for prohibited therapies.
  • 23. Subject has history of allergy or hypersensitivity to study drug components.
  • 24. Subject has received a live/attenuated vaccine within 30 days of first treatment.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Spain7 sites

  • Local Institution - 403

    Barcelona, 08035

  • Local Institution - 402

    Barcelona, 08916

  • Local Institution - 400

    Madrid, 28041

  • Local Institution - 406

    Majadahonda, Madrid, 28222

  • Local Institution - 404

    Málaga, 29010

  • Local Institution - 405

    Valencia, 46010

  • Local Institution - 401

    Valencia, 46026

Other trials in Spain

France3 sites

  • Local Institution - 102

    Marseille, 13385

  • Local Institution - 103

    Saint-Herblain, 44800

  • Local Institution - 100

    Villejuif, 94805

Other trials in France

Italy3 sites

  • Local Institution - 203

    Ancona, 60126

  • Local Institution - 200

    Bologna, 40138

  • Local Institution - 201

    Rozzano (MI), 20089

Other trials in Italy

About this study

Official title: A Phase 1b, Multicenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of CC-90011 Given in Combination With Cisplatin and Etoposide in First Line, Extensive Stage Subjects With Small Cell Lung Cancer

CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

Being tested
CC-90011, Cisplatin, Carboplatin, Etoposide, Nivolumab
Keywords
Safety, CC-90011, Extensive stage small cell lung cancer
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.

Study groups in NCT03850067
Study groupRoleWhat they receive
CC-90011 in combination with Cisplatin and EtoposideExperimentalDuring the Chemotherapy Treatment Period, the dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg as determined by Bayesian design, administered orally Days 1 and 8, in combination with cisplatin intravenous (IV) 75 mg/m2, Day 1, and etoposide iv 100 mg/m2 on Days 1, 2, and 3, for 4 cycles of 21 days each. Subjects completing the chemotherapy and being responders as per RECIST 1.1 will enter the Maintenance Treatment Period. Subjects completing 6 cycles of maintenance treatment subject will be treated only with CC-90011 at RP2D (60 mg) and continuing on CC-90011 are only required to have clinic visits/assessments performed on Day 1 (± 3 days) of each subsequent cycle (Cycles 6 and higher) unless more frequent visits are clinically indicated.
Receives: Drug: CC-90011; Drug: Cisplatin
CC-90011 in combination with Carboplatin and EtoposideExperimentalDuring the Chemotherapy Treatment Period, the dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg as determined by Bayesian design, administered orally Days 1 and 8, in combination with cisplatin intravenous (IV) 75 mg/m2, Day 1, and etoposide iv 100 mg/m2 on Days 1, 2, and 3, for 4 cycles of 21 days each. Subjects completing the chemotherapy and being responders as per RECIST 1.1 will enter the Maintenance Treatment Period. Subjects completing 6 cycles of maintenance treatment subject will be treated only with CC-90011 at RP2D (60 mg) and continuing on CC-90011 are only required to have clinic visits/assessments performed on Day 1 (± 3 days) of each subsequent cycle (Cycles 6 and higher) unless more frequent visits are clinically indicated
Receives: Drug: Carboplatin; Drug: Etoposide
Nivolumab combinationExperimentalWhen the RP2D of CC-90011 in combination with cisplatin or carboplatin and etoposide is determined, the combination of CC-90011 at RP2D with cisplatin or carboplatin and etoposide plus nivolumab IV 240 mg Day 1 of each chemotherapy cycle, will be explored. For CC-90011 in combination with chemotherapy and nivolumab, the starting dose will be the RP2D of CC-90011 in combination with chemotherapy. A maintenance therapy will be given to subjects responding to the combination of CC-90011 with chemotherapy or to chemotherapy with nivolumab, as per RECIST 1.1. These subjects will receive 60 mg or 40 mg (in case of combination with nivolumab) of CC-90011 orally once weekly on Days 1, 8, 15, and 22, during cycles of 28-day each and, in the case of the combination with nivolumab, nivolumab IV 480 mg on Day 1 during cycles of 28-day each.
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

    A DLT is defined as any of the toxicities described in the protocol occurring within the DLT assessment unless the event can clearly be determined to be unrelated to CC-90011

    Measured: Up to approximately 2 years

  2. Maximum Tolerated Dose (MTD)

    MTD is the highest dose that causes DLTs in not more than 33% of the subjects treated with CC-90010 in the first cycle with at least 6 evaluable subjects treated at this dose

    Measured: Up to approximately 2 years

  3. Adverse Events (AEs)

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE

    Measured: Up to approximately 3 years

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR).

    Measured: Up to approximately 2 years

  2. Progression-free Survival (PFS)

    Is defined as the time from the first dose of study drug to the first occurrence of disease progression or death from any cause.

    Measured: Up to approximately 2 years

  3. Overall Survival (OS)

    Is measured as the time from the first dose of CC-90011 to death due to any cause.

    Measured: Up to approximately 2 years

  4. Pharmacokinetics- Cmax

    Maximum observed plasma concentration

    Measured: Up to approximately 2 years

  5. Pharmacokinetics- AUC

    Area under the plasma concentration time-curve

    Measured: Up to approximately 2 years

  6. Pharmacokinetics- Tmax

    Time to maximum plasma concentration

    Measured: Up to approximately 2 years

  7. Pharmacokinetics- t1/2

    Terminal half-life

    Measured: Up to approximately 2 years

  8. Pharmacokinetics- CL/F

    Apparent clearance

    Measured: Up to approximately 2 years

  9. Pharmacokinetics- VzF

    Apparent volume of distribution

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start12 Mar 2019
  3. Primary completion16 Jul 2024
  4. Study completion16 Jul 2024

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850067
Sponsor's protocol ID
CC-90011-SCLC-001
Other IDs
U1111-1228-2067, 2018-002799-42, 2018
Status last verified
Aug 2024
First submitted
20 Feb 2019
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Publications

  • Kanouni T, Severin C, Cho RW, Yuen NY, Xu J, Shi L, Lai C, Del Rosario JR, Stansfield RK, Lawton LN, Hosfield D, O'Connell S, Kreilein MM, Tavares-Greco P, Nie Z, Kaldor SW, Veal JM, Stafford JA, Chen YK. Discovery of CC-90011: A Potent and Selective Reversible Inhibitor of Lysine Specific Demethylase 1 (LSD1). J Med Chem. 2020 Dec 10;63(23):14522-14529. doi: 10.1021/acs.jmedchem.0c00978. Epub 2020 Oct 9.

    PubMed 33034194

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-90011, Cisplatin and Carboplatin in people with Small Cell Lung Carcinoma, run by Celgene at 13 sites in 3 countries.

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 24 inclusion and 34 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: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, France, Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose-Limiting Toxicity (DLT) (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850067, which also lists 1 linked publication.

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 26 Aug 2024.

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