Solid TumorsPhase 1NCT01930292
Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies
A Phase 1 study testing Part A: Debio 1143, Paclitaxel and Carboplatin in people with Solid Tumors, run by Debiopharm International SA at 4 sites in France.
Trial summary
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Part A: Debio 1143, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2013to Mar 2016
- 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
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Who cannot join
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or
- the analysis of results
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Georges François Leclerc
Dijon, 21079
Centre Léon Bérard
Lyon, 69008
Institut Curie
Paris, 75248
Institut Claudius Regaud
Toulouse, 31052
About this study
Official title: A Phase I Study to Evaluate the Safety and Determine the Maximum Tolerated Dose (MTD) of Debio 1143 Combined With Carboplatin and Paclitaxel in Patients With Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-refractory Ovarian Cancer, and Basal-like/Claudin Low Triple Negative Breast Cancer (TNBC)
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC).
The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.
The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.
- Conditions
- Solid Tumors
- Being tested
- Part A: Debio 1143, Paclitaxel, Carboplatin, Part B: Debio 1143
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A: Debio 1143Drug
Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.
PaclitaxelDrug
Paclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions.
CarboplatinDrug
Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle.
Part B: Debio 1143Drug
RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Debio 1143 | Experimental | Eligible participants receive Part A: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle according to dose escalation rules (in combination with Paclitaxel and Carboplatin standard of care) Receives: Drug: Part A: Debio 1143; Drug: Paclitaxel; Drug: Carboplatin |
| Part B: Lung Cancer | Experimental | Participants with Lung Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care) Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Part B: Debio 1143 |
| Part B: Ovarian Cancer | Experimental | Participants with Ovarian Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care) Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Part B: Debio 1143 |
| Part B: Breast Cancer | Experimental | Participants with Breast Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care) Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Part B: Debio 1143 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants with dose-limiting toxicities
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part B: Percentage of participants with adverse events (AEs) and serious AEs (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Measured: up to 18 weeks + 28 days
Secondary outcomes (42)
Part A: Percentage of participants with AEs and serious adverse events (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks + 28 days
Part A: Number of participants with change in vital signs
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part A: Number of participants with change in electrocardiogram (ECG)
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part A: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part B: Number of participants with change in vital signs
Categories: each indication at the recommended dose (RD)
Measured: up to 18 weeks
Part B: Number of participants with change in electrocardiogram (ECG)
Categories: each indication at the recommended dose (RD)
Measured: up to 18 weeks
Part B: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Categories: each indication at the recommended dose (RD)
Measured: up to 18 weeks
Part A: Percentage of participants with incidence of laboratory abnormalities according to NCI-CTCAE criteria
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part B: Percentage of participants with incidence of laboratory abnormalities according to NCI-CTCAE criteria
Categories: each indication at the RD
Measured: up to 18 weeks
Part A: Percentage of participants with treatment discontinuations due to AEs and SAEs
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks + 28 days
Part B: Percentage of participants with treatment discontinuations due to AEs and SAEs
Categories: each indication at the RD
Measured: up to 18 weeks + 28 days
Part A: Number of participants with change in left ventricular ejection fraction (LVEF)
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part B: Number of participants with change in left ventricular ejection fraction (LVEF)
Categories: each indication at the RD
Measured: up to 18 weeks
Part A: Number of participants with tumour response: disease control, change in tumour size from baseline and overall response
Categories: each Debio 1143 dose level and overall
Measured: up to 18 weeks
Part B: Number of participants with tumour response: disease control, change in tumour size from baseline and overall response
Categories: each indication at the RD
Measured: up to 18 weeks
Part A: Percentage of participants with progression-free survival (PFS) at 6 months
Categories: each Debio 1143 dose level and overall
Measured: at 6 months
Part B: Percentage of participants with progression-free survival (PFS) at 6 months
Categories: each indication at the RD
Measured: at 6 months
Part A: Percentage of participants with survival at 1 year
Categories: each Debio 1143 dose level and overall
Measured: at 12 months
Part B: Percentage of participants with survival at 1 year
Categories: each indication at the RD
Measured: at 12 months
Part B: Maximum concentration (Cmax) in the pharmacokinetic (PK) subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Lowest concentration before the next dose (Ctrough) of Debio 1143 in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Time to maximum concentration (tmax) in the PK subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Area under the concentration versus time curve from the beginning to a point in time (AUC0-t) in the PK subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Area under the concentration versus time curve extrapolated to infinity (AUC∞) in the PK subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Terminal rate constant (λz) in the PK subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Apparent terminal half-life (t½) in the PK subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Mean residence time (MRT) in the PK subset
Categories: Debio 1143 alone; Debio 1143 when administered with paclitaxel and carboplatin; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Apparent clearance (CL/F) of Debio 1143 in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Apparent volume of distribution during the terminal phase (Vz/F) of Debio 1143 in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Total amount of Debio 1143 excreted in urine (Ae) in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Total amount of Debio 1143 excreted in urine in the first 8 hours (Ae0-8) in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Total amount of Debio 1143 excreted in urine between 8 and 24 hours (Ae8-24) in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Renal clearance calculated as Ae/AUC∞ (CLR) of Debio 1143 in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Fraction of the dose excreted in urine calculated as Ae/dose (fe) of Debio 1143 in the PK subset
Categories: alone and in combination with chemotherapy
Measured: up to 18 weeks
Part B: Area under the concentration versus time curve in the first 12 hours (AUC0-12) in the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Total body clearance (CL) in the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Volume of distribution at steady-state (Vss) in the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Mean Residence Area under the concentration versus time curve (MR,AUC) in the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Mean Residence Maximum Concentration (MR,Cmax) in the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Platinum Refraction (PtR) in ovarian cancer participants included in the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Cmax in patients other than the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Part B: Concentration observed at time n (Cn) following Debio 1143 administration in patients other than the PK subset
Categories: paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered as chemotherapy alone; paclitaxel, 6αOH-paclitaxel (metabolite), and carboplatin (total and free Pt) when administered in combination with Debio 1143
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Part B was cancelled based on business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Delord, MD, Study chair, Institut Claudius Regaud, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930292
- Sponsor's protocol ID
- Debio 1143-103
- Other IDs
- 2012-003676-40
- Status last verified
- Mar 2016
- First submitted
- 21 Jun 2013
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Determine the Maximum Tolerated Dose (MTD) of Debio 1143 Combined With Carboplatin and Paclitaxel in Patients With Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-refractory Ovarian Cancer, and Basal-like/Claudin Low Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT01930292
- Acronym / sponsor ID
- Debio 1143-103
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part B was cancelled based on business decision
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Aug 2013 (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.
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC).
The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.
The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Debio 1143 | Experimental | Drug: Part A: Debio 1143, Drug: Paclitaxel, Drug: CarboplatinEligible participants receive Part A: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle according to dose escalation rules (in combination with Paclitaxel and Carboplatin standard of care) |
| Part B: Lung Cancer | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Part B: Debio 1143Participants with Lung Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care) |
| Part B: Ovarian Cancer | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Part B: Debio 1143Participants with Ovarian Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care) |
| Part B: Breast Cancer | Experimental | Drug: Paclitaxel, Drug: Carboplatin, Drug: Part B: Debio 1143Participants with Breast Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Key exclusion criteria (5 listed)
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| Part A: Debio 1143Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined. | Drug | Part A: Debio 1143 |
| PaclitaxelPaclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions. | Drug | Part A: Debio 1143, Part B: Breast Cancer, Part B: Lung Cancer, Part B: Ovarian Cancer |
| CarboplatinCarboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle. | Drug | Part A: Debio 1143, Part B: Breast Cancer, Part B: Lung Cancer, Part B: Ovarian Cancer |
| Part B: Debio 1143RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle. | Drug | Part B: Breast Cancer, Part B: Lung Cancer, Part B: Ovarian Cancer |
Primary outcome
Part A: Number of participants with dose-limiting toxicities
Time frame: up to 18 weeks
Categories: each Debio 1143 dose level and overall
Part B: Percentage of participants with adverse events (AEs) and serious AEs (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Time frame: up to 18 weeks + 28 days
42 secondary outcomes
Part A: Percentage of participants with AEs and serious adverse events (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Time frame: up to 18 weeks + 28 days
Part A: Number of participants with change in vital signs
Time frame: up to 18 weeks
Part A: Number of participants with change in electrocardiogram (ECG)
Time frame: up to 18 weeks
Part A: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Time frame: up to 18 weeks
Part B: Number of participants with change in vital signs
Time frame: up to 18 weeks
Part B: Number of participants with change in electrocardiogram (ECG)
Time frame: up to 18 weeks
Part B: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Time frame: up to 18 weeks
Part A: Percentage of participants with incidence of laboratory abnormalities according to NCI-CTCAE criteria
Time frame: up to 18 weeks
Part B: Percentage of participants with incidence of laboratory abnormalities according to NCI-CTCAE criteria
Time frame: up to 18 weeks
Part A: Percentage of participants with treatment discontinuations due to AEs and SAEs
Time frame: up to 18 weeks + 28 days
Part B: Percentage of participants with treatment discontinuations due to AEs and SAEs
Time frame: up to 18 weeks + 28 days
Part A: Number of participants with change in left ventricular ejection fraction (LVEF)
Time frame: up to 18 weeks
Part B: Number of participants with change in left ventricular ejection fraction (LVEF)
Time frame: up to 18 weeks
Part A: Number of participants with tumour response: disease control, change in tumour size from baseline and overall response
Time frame: up to 18 weeks
Part B: Number of participants with tumour response: disease control, change in tumour size from baseline and overall response
Time frame: up to 18 weeks
Part A: Percentage of participants with progression-free survival (PFS) at 6 months
Time frame: at 6 months
Part B: Percentage of participants with progression-free survival (PFS) at 6 months
Time frame: at 6 months
Part A: Percentage of participants with survival at 1 year
Time frame: at 12 months
Part B: Percentage of participants with survival at 1 year
Time frame: at 12 months
Part B: Maximum concentration (Cmax) in the pharmacokinetic (PK) subset
Time frame: up to 18 weeks
Part B: Lowest concentration before the next dose (Ctrough) of Debio 1143 in the PK subset
Time frame: up to 18 weeks
Part B: Time to maximum concentration (tmax) in the PK subset
Time frame: up to 18 weeks
Part B: Area under the concentration versus time curve from the beginning to a point in time (AUC0-t) in the PK subset
Time frame: up to 18 weeks
Part B: Area under the concentration versus time curve extrapolated to infinity (AUC∞) in the PK subset
Time frame: up to 18 weeks
Part B: Terminal rate constant (λz) in the PK subset
Time frame: up to 18 weeks
Part B: Apparent terminal half-life (t½) in the PK subset
Time frame: up to 18 weeks
Part B: Mean residence time (MRT) in the PK subset
Time frame: up to 18 weeks
Part B: Apparent clearance (CL/F) of Debio 1143 in the PK subset
Time frame: up to 18 weeks
Part B: Apparent volume of distribution during the terminal phase (Vz/F) of Debio 1143 in the PK subset
Time frame: up to 18 weeks
Part B: Total amount of Debio 1143 excreted in urine (Ae) in the PK subset
Time frame: up to 18 weeks
Part B: Total amount of Debio 1143 excreted in urine in the first 8 hours (Ae0-8) in the PK subset
Time frame: up to 18 weeks
Part B: Total amount of Debio 1143 excreted in urine between 8 and 24 hours (Ae8-24) in the PK subset
Time frame: up to 18 weeks
Part B: Renal clearance calculated as Ae/AUC∞ (CLR) of Debio 1143 in the PK subset
Time frame: up to 18 weeks
Part B: Fraction of the dose excreted in urine calculated as Ae/dose (fe) of Debio 1143 in the PK subset
Time frame: up to 18 weeks
Part B: Area under the concentration versus time curve in the first 12 hours (AUC0-12) in the PK subset
Time frame: up to 18 weeks
Part B: Total body clearance (CL) in the PK subset
Time frame: up to 18 weeks
Part B: Volume of distribution at steady-state (Vss) in the PK subset
Time frame: up to 18 weeks
Part B: Mean Residence Area under the concentration versus time curve (MR,AUC) in the PK subset
Time frame: up to 18 weeks
Part B: Mean Residence Maximum Concentration (MR,Cmax) in the PK subset
Time frame: up to 18 weeks
Part B: Platinum Refraction (PtR) in ovarian cancer participants included in the PK subset
Time frame: up to 18 weeks
Results and safety
The study was stopped early (reason given: Part B was cancelled based on business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- 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.
Jean-Pierre Delord, MD study chair
Institut Claudius Regaud, Toulouse, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part A: Debio 1143, Paclitaxel and Carboplatin in people with Solid Tumors, run by Debiopharm International SA at 4 sites in France.
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 3 inclusion and 5 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 (reason given: Part B was cancelled based on business decision). 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?
Part A: Number of participants with dose-limiting toxicities (time frame: up to 18 weeks). 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 24 Mar 2016.