Non-small Cell Lung CancerPhase 1HALONCT01714037
A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]
A Phase 1 study testing Debio 0932, Cisplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by Debiopharm International SA at 8 sites in 3 countries.
Trial summary
Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Debio 0932, Cisplatin and Pemetrexed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Aug 2012to Nov 2014
- 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
- Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation
- Advanced or metastatic disease (Stage IIIb or IV)
- Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy
- Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- ECOG performance score 0-1
- Life expectancy ≥ 3 months
- Adequate bone marrow-, renal- and hepatic function
- LVEF ≥ 55% on cardiac ultrasound
Who cannot join
- Symptomatic brain metastases
- Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease)
- Concurrent treatment with any other systemic anti-cancer therapy
- Serious concomitant uncontrolled medical conditions
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France4 sites
Centre GF Leclerc
Dijon
Centre Léon Bérard
Lyon
Institut de Cancérologie de l'Ouest- Institut René Gauduchau
Nantes
Institut Claudius Regaud
Toulouse
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Puerta de Hierro Majadahonda
Madrid
Hospital Universitario Virgen del Rocío
Seville
About this study
Official title: A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)
Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.
Read the detailed description
Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.
Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Debio 0932, Cisplatin, Pemetrexed, Gemcitabine, Docetaxel
- Keywords
- Safety, Efficacy, HSP90, Debio 0932, Standard of care treatment, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debio 0932Drug
Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).
CisplatinDrug
Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.
PemetrexedDrug
Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.
GemcitabineDrug
Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.
DocetaxelDrug
Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin, Pemetrexed, Debio 0932 | Experimental | Cisplatin, Pemetrexed, Debio 0932 Receives: Drug: Debio 0932; Drug: Cisplatin; Drug: Pemetrexed |
| Cisplatin, Gemcitabine, Debio 0932 | Experimental | Cisplatin, Gemcitabine, Debio 0932 Receives: Drug: Debio 0932; Drug: Cisplatin; Drug: Gemcitabine |
| Docetaxel, Debio 0932 | Experimental | Docetaxel, Debio 0932 Receives: Drug: Debio 0932; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities
Measured: 6 weeks
Secondary outcomes (10)
Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Measured: Day 1 of each treatment cycle until disease progression or study drug toxicity
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Every treatment cycle until disease progression or study drug toxicity
Incidence of laboratory abnormalities
Measured: 2 to 4 times every treatment cycle until disease progression or study drug toxicity
Incidence of treatment discontinuations due to AEs and SAEs
Measured: Every treatment cycle until diseases progression or study drug toxicity
Change in left ventricular ejection fraction (LVEF)
Measured: Baseline and after 4 weeks of treatment
Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1
Measured: 22 days
Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel
Measured: 22 days
Best overall tumor response
Measured: 22 days
Pharmacodynamic biomarkers
Measured: 22 days
Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Nicolas Isambert, MD, Principal investigator, Centre GF Leclerc, Dijon, FranceJean-Pierre Delord, PR, Principal investigator, Institut Claudius Regaud, Toulouse, FranceJèrôme Fayette, MD, Principal investigator, Centre Léon Bérard, Lyon, FranceJaafar Bennouma, MD, Principal investigator, Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, FranceLuis Paz-Ares, PR, Principal investigator, Hospital Universitario Virgen del Rocío, Seville, SpainEnriqueta Felip, PR, Principal investigator, Hospital Universitari Vall d'Hebron, Barcelone, SpainMariano Provencio, PR, Principal investigator, Hospital Puerta de Hierro Majadahonda, Madrid, SpainRuth Plummer, PR, Principal investigator, Freeman Hospital, Newcastle, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714037
- Sponsor's protocol ID
- Debio 0932-201
- Acronym
- HALO
- Status last verified
- Apr 2015
- First submitted
- 3 Oct 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)
- ClinicalTrials.gov ID
- NCT01714037
- Acronym / sponsor ID
- HALO / Debio 0932-201
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Safety, Efficacy, HSP90, Debio 0932, Standard of care treatment, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Aug 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 25 Oct 2012 (estimated)
- 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.
Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.
Detailed description
Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.
Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cisplatin, Pemetrexed, Debio 0932 | Experimental | Drug: Debio 0932, Drug: Cisplatin, Drug: PemetrexedCisplatin, Pemetrexed, Debio 0932 |
| Cisplatin, Gemcitabine, Debio 0932 | Experimental | Drug: Debio 0932, Drug: Cisplatin, Drug: GemcitabineCisplatin, Gemcitabine, Debio 0932 |
| Docetaxel, Debio 0932 | Experimental | Drug: Debio 0932, Drug: DocetaxelDocetaxel, Debio 0932 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation
- Advanced or metastatic disease (Stage IIIb or IV)
- Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy
- Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- ECOG performance score 0-1
Key exclusion criteria (4 listed)
- Symptomatic brain metastases
- Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease)
- Concurrent treatment with any other systemic anti-cancer therapy
- Serious concomitant uncontrolled medical conditions
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 |
|---|---|---|
| Debio 0932Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD). | Drug | Cisplatin, Gemcitabine, Debio 0932, Cisplatin, Pemetrexed, Debio 0932, Docetaxel, Debio 0932 |
| CisplatinCisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle. | Drug | Cisplatin, Gemcitabine, Debio 0932, Cisplatin, Pemetrexed, Debio 0932 |
| PemetrexedPemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle. | Drug | Cisplatin, Pemetrexed, Debio 0932 |
| GemcitabineGemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle. | Drug | Cisplatin, Gemcitabine, Debio 0932 |
| DocetaxelDocetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle. | Drug | Docetaxel, Debio 0932 |
Primary outcome
Occurrence of Dose Limiting Toxicities
Time frame: 6 weeks
10 secondary outcomes
Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame: Day 1 of each treatment cycle until disease progression or study drug toxicity
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Every treatment cycle until disease progression or study drug toxicity
Incidence of laboratory abnormalities
Time frame: 2 to 4 times every treatment cycle until disease progression or study drug toxicity
Incidence of treatment discontinuations due to AEs and SAEs
Time frame: Every treatment cycle until diseases progression or study drug toxicity
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline and after 4 weeks of treatment
Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1
Time frame: 22 days
Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel
Time frame: 22 days
Best overall tumor response
Time frame: 22 days
Pharmacodynamic biomarkers
Time frame: 22 days
Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932
Time frame: 7 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Site Debiopharm SALink provided by the sponsor.
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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.
Nicolas Isambert, MD principal investigator
Centre GF Leclerc, Dijon, France
Jean-Pierre Delord, PR principal investigator
Institut Claudius Regaud, Toulouse, France
Jèrôme Fayette, MD principal investigator
Centre Léon Bérard, Lyon, France
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Debio 0932, Cisplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by Debiopharm International SA at 8 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Spain, United Kingdom. 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 was stopped early. Results are not available in the source record.
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?
Occurrence of Dose Limiting Toxicities (time frame: 6 weeks). 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 8 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.