A Dose Finding and Expansion Study of RO7051790 Administered Orally in Participants With Relapsed, Extensive-Stage Disease Small Cell Lung Cancer (ED SCLC)
Status and phase
Completed
Phase 1
Conditions
Small Cell Lung Cancer
Treatments
Drug: RO7051790
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This is a Phase I, open-label, multicenter study designed to assess the safety and tolerability of RO7051790 in participants with relapsed ED SCLC. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RO7051790, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of RO7051790.
Enrollment
18 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Life expectancy greater than or equal to (>=) 12 weeks
- Participants must have histologically or cytologically confirmed diagnosis of SCLC
- Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or standard therapy is refused or not suitable. For participants in Canada: participants should also not be suitable for treatment with topotecan hydrochloride
- Acute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade less than or equal to (<=) 1
- Measureable disease per RECIST v1.1 prior to administration of study medication
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate bone marrow function
- Adequate renal function
- Participant must be able to swallow and retain orally administered study treatment
- Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for a period of time after the last dose of study treatment
Exclusion criteria
- Active malignancy other than SCLC within the previous 5 years
- Participants who have received radiotherapy less than 2 weeks prior to first dose of study medication
- Surgical procedure or clinically significant trauma within 2 weeks of first dose of study treatment
- Treatment with any investigational agent <=3 weeks prior to first dose of study treatment
- Participants with gastrectomy or pre-existing gastrointestinal disorders that may interfere with the proper absorption of the drug(s), as per conclusion of the clinical Investigator
- Participants medicated with anti-depressants reported to have lysine-specific histone demethylase 1A (KDM1A)/lysine (K)-specific demethylase 1A (LSD1) inhibitory activity (such as tranylcypromine or phenelzine) within 28 days of treatment start
- History of allergic reactions attributed to components of the formulated product(s)
- History of seizure disorders
- Participants with untreated central nervous system metastases, or history of previously treated disease. Participants must have stable hematological parameters, satisfying eligibility, platelet count must be stable for >=2 weeks prior to study drug administration
- Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Participants with evidence of electrolyte imbalance
- Participants who are pregnant or breastfeeding
- Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
- Participants with known bone marrow disorders which may interfere with bone marrow recovery or participants with delayed recovery from prior chemoradiotherapy
- Participants with known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
- Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)-positive participants with active infection
- Use of strong Cytochrome P450 3A4 (CYP3A4) inducers while on study medication
- Participants with abnormal hepatic function
- Participants with history of clinically significant bleeding, specifically any history of intracranial hemorrhage/hemorrhagic cardiovascular accident (CVA), or participants with gastrointestinal bleeding within the 12 months prior to study entry
- Participants receiving therapeutic anti-coagulation or anti-platelet (anti-aggregant) therapies, except for therapeutic enoxaparin or low dose aspirin. Use of subcutaneous heparin prophylaxis, including low molecular weight heparin is also permitted
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
18 participants in 4 patient groups
Introductory Cohort - 400 μg RO7051790
Experimental group
Description:
Introductory cohort to ensure participant safety, prior to the dose escalation study. 400 μg of RO7051790 was administered to two (2) participants followed by a 21-day DLT observation period.
Treatment:
Drug: RO7051790
Dose Escalation - 1000 μg RO7051790
Experimental group
Description:
1000 μg of RO7051790 was administered to six (6) participants once every 3 weeks (Q3W).
Treatment:
Drug: RO7051790
Dose Escalation - 1300 μg RO7051790
Experimental group
Description:
1300 μg of RO7051790 was administered to seven (7) participants once every 3 weeks (Q3W).
Treatment:
Drug: RO7051790
Dose Escalation - 1900 μg RO7051790
Experimental group
Description:
1900 μg of RO7051790 was administered to three (3) participants once every 3 weeks (Q3W).
Treatment:
Drug: RO7051790
Trial contacts and locations
8
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Data sourced from clinicaltrials.gov
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