Advanced CancerPhase 1/2NCT02684318
Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors
A Phase 1/2 study testing PM01183 + olaparib in people with Advanced Cancer and Ovarian Cancer, run by Poveda, Andrés, M.D. at 6 sites in Spain.
Trial summary
Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Ovarian Cancer, Endometrial Cancer
- What is being tested?
- PM01183 + olaparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesSpain
- Study dates
- Jul 2015to Oct 2019
- 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
- Patients ≥18 years of age, no upper age limit.
- Written informed consent obtained prior to any study specific procedures or assessments.
- Histologically confirmed diagnosis of cancer:
- Phase I: patients with advanced or metastatic solid tumors without established standard therapeutic alternatives.
- Phase II: platinum-resistant ovarian cancer patients (epithelial non-mucinous), triple negative breast cancer and endometrial cancer (any grade).
- For patients included in the phase II part of the study, evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 is required.
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- At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements, OR
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by (CT/MRI/plain x-ray) at baseline and follow up visits.
- Patients included in the phase II part of the study must have received at least one line of standard therapy for locally advanced or metastatic disease, and developed progression disease afterwards.
- ECOG score < 2.
- Life expectancy of ≥ 3 months.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Haemoglobin ≥ 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomisation (choose whichever is most applicable to the study).
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- No features suggestive of myelodisplastic syndrome (MSD)/ Acute myeloid leukaemia (AML) on peripheral blood smear c. White blood cells (WBC) > 3x109/L d. Platelet count ≥ 100 x 109/L e. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) f. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present in which case it must be ≤ 5x ULN g. Albumin ≥ 3.0 g/dl h. Serum creatinine ≤ 1.5 x institutional ULN i. Creatinine clearance ≥ 30 ml/min.
- Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Evidence of non-childbearing status for women of childbearing potential (WOCBP)*.
- WOCBP should only be included after a confirmed menstrual period and a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.. The inclusion of WOCBP requires use of a highly effective contraceptive measure (Appendix H).
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study.
- Previous enrolment or randomization in the present study.
- Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
- For patients included in the phase I of the study, previous treatment with olaparib or PM01183. For patients included in the phase II of the study, any previous treatment with a PARP inhibitor, including olaparib, or PM01183.
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
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- Olaparib and PM01183 are metabolized mainly by CYP3A4. Therefore, concomitant use of known strong CYP3A4 inhibitors such as ketokonazole, itraconazole, telithromycin and clarithromycin are forbidden. Concomitant use of known CYP3A4 strong inducers. (See Appendix K for a list of CYP inducers, inhibitors and substrates).
- Persistent toxicities (≥ CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy.
- Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Patients with myelodysplastic syndrome/acute myeloid leukaemia.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment.
- Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Breast feeding women.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
- Patients with known active hepatic disease (i.e., Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
- Patients who present any contraindication or suspected allergy to the products (or any of the excipients) under investigation in the study.
- Patients with uncontrolled seizures.
- For patients included at the phase II part of the study: patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated insitu cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Ana Oaknin, MD, 0034934894158, opadros@vhio.net
Ana Oaknin, MD
- Recruiting
Hospital Reina Sofía
Córdoba, Andalusia, 14004
Maria Jesus Rubio, MD
- Recruiting
Hospital Ramón y Cajal
Madrid, 28034
Eva Guerra, MD
- Recruiting
Hospital La Paz
Madrid, 28046
Andrés Redondo, MD
- Recruiting
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Ana de Juan
- Recruiting
Fundación Instituto Valenciano de Oncología
Valencia, 46009
Andrés Poveda, MD, 0034961104647, apoveda@fivo.org
Andrés Poveda, MD
About this study
Official title: Phase Ib/II Study to Evaluate the Efficacy and Tolerability of PM01183 in Combination With Olaparib in Patients With Advanced Solid Tumors
Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors.
Read the detailed description
The study will be split into 2 parts: an open label Phase I dose escalation part followed by a non-randomized Phase II part, as an expansion study, in patients with selected tumors at the recommended doses and schedule determined in the phase I.
Phase I: A dose escalation study will be performed in patients with advanced or metastatic solid tumors without established standard therapeutic alternatives.
Phase II: An expansion dose study selecting patients with potential tumors with possibly sensitivity to PARP inhibitors according to histology, including triple negative breast cancer, high grade serous platinum-resistant ovarian and endometrial cancer patients, or patients with molecular features such as endometrial cancer with PTEN loss, breast or ovarian cancer with PTEN loss, known BRCA1/2 germline, somatic mutation or somatic methylation.
OBJECTIVES:
Primary objectives:
Phase Ib: To establish the safety [dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II doses (RP2D)], of orally administered olaparib in combination with PM01183 in patients with advanced or metastatic solid tumors without established standard therapeutic alternatives.
Phase II: To assess the efficacy in terms of Tumor response rate according to RECIST v1.1 criteria of PM01183 in combination with olaparib in the selected populations.
Secondary objectives
Phase Ib:
To explore the pharmacokinetics of PM01183 and olaparib when administered in combination. To determine the effects of the study treatment on the level of PARP activity and
DNA damage in:
- Peripheral blood mononuclear cells (PBMC).
- Circulating tumor cells (CTC).
- Tumor biopsy samples. To evaluate the preliminary antitumor activity (overall response rate) by RECIST of the combination in the exposed population.
Phase II:
Progression free survival. Overall Survival. Toxicity profile of the combination in patients enrolled in the study. To explore the possible correlation between the expression of certain biomarkers and the efficacy of this therapeutic approach.
STATISTICAL PROCEDURES
- Sample size. Justification
Phase I:
Between 18-48 patients are expected to participate in the Phase Ib part of the study. The number of patients may vary depending upon the tolerability of the combination and the number of dose levels required to identify the MTD.
Phase II:
A total accrual up to 73 subjects would be required, according to an MinMax two-stages Simon design. With an α-error 0.05 and a power 90%, RR with a poor scenario according previous one would be 24%, and in a favourable scenario RR would reach 40%.
Progression-free survival according to previous reported is 3.5 months and the objective for the study is 6.5 months (n=56). According to this objective, the maximum sample size is 73 patients, and first sample size is 61 patients (upper limit for first stage rejection: 18).
Two stages are established:
- In the first step 61 evaluable patients will be included in the study. If 18 or fewer responses are observed, the study will be stopped due to an inadequate response rate. Efficacy data for the patients included at this first step will be reviewed by an independent assessment committee (IAC).
- If 19 or more responses are observed recruitment will continue until the group has 73 evaluable patients. If 23 or fewer responses are detected among these 73 patients, it will be concluded that the regimen is not sufficiently active to warrant further testing. If 24 or more responses are observed it will be concluded that the regimen is sufficiently active to warrant further testing in posterior Phase III.
- Conditions
- Advanced Cancer, Ovarian Cancer, Endometrial Cancer, Breast Cancer
- Being tested
- PM01183 + olaparib
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM01183 + olaparibDrug
Also called Lynparza, Lurbinectedin
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | PM01183 + olaparib PM01183: 1 mg/m² IV olaparib 100 mg BID Receives: Drug: PM01183 + olaparib |
| Dose Level 2 | Experimental | PM01183 + olaparib PM01183: 1 mg/m² IV olaparib 150 mg BID Receives: Drug: PM01183 + olaparib |
| Dose Level 3 | Experimental | PM01183 + olaparib PM01183: 1.5 mg/m² IV olaparib 200 mg BID Receives: Drug: PM01183 + olaparib |
| Dose Level 4 | Experimental | PM01183 + olaparib PM01183: 1.5 mg/m² IV olaparib 250 mg BID Receives: Drug: PM01183 + olaparib |
| Dose Level 5 | Experimental | PM01183 + olaparib PM01183: 2 mg/m² IV olaparib 250 mg BID Receives: Drug: PM01183 + olaparib |
| Dose Level 6 | Experimental | PM01183 + olaparib PM01183: 2 mg/m² IV olaparib 300 mg BID Receives: Drug: PM01183 + olaparib |
| Dose Level 7 | Experimental | PM01183 + olaparib PM01183 3 mg/m² IV olaparib 300 mg BID Receives: Drug: PM01183 + olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
To establish the Dose Limiting Toxicity in the dose escaltion study phase I
Measured: 1 year
Maximum tolerated dose
To establish the Maximum tolerated dose in the dose escaltion study phase I
Measured: 1 year
Efficacy in terms of Tumor Response Rate according to RECIST 1.1 criteria.
to assess the efficacy in terms of Tumor response rate according to RECIST 1.1 criteria of PM01183 in combination with olaparib in the selected populations
Measured: 3 years
Secondary outcomes (5)
Pharmacodynamic evaluation to assess the increasing activity in DNA damage
Pharmacodynamic evaluation to assess the increasing activity in DNA damage of the combination of PM01183+Olaparib ((double strand break).
Measured: 1 year
Overall response rate
To evaluate the preliminary antitumor activity (overall response rate) by RECIST of the combination in the exposed population.
Measured: 3 years
Progression free survival.
The time from inclusion until objective tumor progression or death from any cause.
Measured: 3 years
Biomarker analysis
To explore the possible correlation between the expression of certain biomarkers and the efficacy of this therapeutic approach.
Measured: 3 years
To demonstrate the predictive capacity and prognostic impact of some of the biomarkers under study.
- In peripheral blood:
- Germline DNA: confirmation of HRD tumor findings if necessary.
- PBMC: γH2AX (0 and X h after olaparib: to be defined after phase I findings) in the first cycle.
- In archival tumor:
- HRD panel by NGS.
- BRCA1 methylation.
- PTEN deficiency by IHC and/or FISH.
- PTEN, BRCA1/2 mutation.
- Tissue array to analyse other biomarkers by IHC (BRCA1 and other HRD genes).
- In biopsy before study entry (limited to 15 patients):
- IHC (RAD-51, PARP, γH2AX, PTEN, BRCA1).
- PTEN, BRCA1/2 mutation.
- Tissue array to analyze other immunohistochemical biomarkers (BRCA1 and other HRD genes).
- In biopsy before study entry (limited to 15 patients):
- IHC (RAD-51, PARP, γH2AX, PTEN, BRCA1).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poveda, Andrés, M.D.
- Collaborators
- AstraZeneca, PharmaMar
- Responsible party
- Sponsor
- Investigators
- Andres Poveda, MD, Principal investigator, Fundación Instituto Valenciano de Oncología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684318
- Sponsor's protocol ID
- POLA/ACOG1401
- Status last verified
- Jun 2017
- First submitted
- 2 Feb 2016
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study to Evaluate the Efficacy and Tolerability of PM01183 in Combination With Olaparib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02684318
- Acronym / sponsor ID
- POLA/ACOG1401
- Conditions
- Advanced Cancer, Ovarian Cancer, Endometrial Cancer, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poveda, Andrés, M.D.
- Collaborators
- AstraZeneca, PharmaMar
- Study start
- Jul 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 18 Feb 2016 (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.
Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors.
Detailed description
The study will be split into 2 parts: an open label Phase I dose escalation part followed by a non-randomized Phase II part, as an expansion study, in patients with selected tumors at the recommended doses and schedule determined in the phase I.
Phase I: A dose escalation study will be performed in patients with advanced or metastatic solid tumors without established standard therapeutic alternatives.
Phase II: An expansion dose study selecting patients with potential tumors with possibly sensitivity to PARP inhibitors according to histology, including triple negative breast cancer, high grade serous platinum-resistant ovarian and endometrial cancer patients, or patients with molecular features such as endometrial cancer with PTEN loss, breast or ovarian cancer with PTEN loss, known BRCA1/2 germline, somatic mutation or somatic methylation.
OBJECTIVES:
Primary objectives:
Phase Ib: To establish the safety [dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II doses (RP2D)], of orally administered olaparib in combination with PM01183 in patients with advanced or metastatic solid tumors without established standard therapeutic alternatives.
Phase II: To assess the efficacy in terms of Tumor response rate according to RECIST v1.1 criteria of PM01183 in combination with olaparib in the selected populations.
Secondary objectives
Phase Ib:
To explore the pharmacokinetics of PM01183 and olaparib when administered in combination. To determine the effects of the study treatment on the level of PARP activity and
DNA damage in:
- Peripheral blood mononuclear cells (PBMC).
- Circulating tumor cells (CTC).
- Tumor biopsy samples. To evaluate the preliminary antitumor activity (overall response rate) by RECIST of the combination in the exposed population.
Phase II:
Progression free survival. Overall Survival. Toxicity profile of the combination in patients enrolled in the study. To explore the possible correlation between the expression of certain biomarkers and the efficacy of this therapeutic approach.
STATISTICAL PROCEDURES
- Sample size. Justification
Phase I:
Between 18-48 patients are expected to participate in the Phase Ib part of the study. The number of patients may vary depending upon the tolerability of the combination and the number of dose levels required to identify the MTD.
Phase II:
A total accrual up to 73 subjects would be required, according to an MinMax two-stages Simon design. With an α-error 0.05 and a power 90%, RR with a poor scenario according previous one would be 24%, and in a favourable scenario RR would reach 40%.
Progression-free survival according to previous reported is 3.5 months and the objective for the study is 6.5 months (n=56). According to this objective, the maximum sample size is 73 patients, and first sample size is 61 patients (upper limit for first stage rejection: 18).
Two stages are established:
- In the first step 61 evaluable patients will be included in the study. If 18 or fewer responses are observed, the study will be stopped due to an inadequate response rate. Efficacy data for the patients included at this first step will be reviewed by an independent assessment committee (IAC).
- If 19 or more responses are observed recruitment will continue until the group has 73 evaluable patients. If 23 or fewer responses are detected among these 73 patients, it will be concluded that the regimen is not sufficiently active to warrant further testing. If 24 or more responses are observed it will be concluded that the regimen is sufficiently active to warrant further testing in posterior Phase III.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183: 1 mg/m² IV olaparib 100 mg BID |
| Dose Level 2 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183: 1 mg/m² IV olaparib 150 mg BID |
| Dose Level 3 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183: 1.5 mg/m² IV olaparib 200 mg BID |
| Dose Level 4 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183: 1.5 mg/m² IV olaparib 250 mg BID |
| Dose Level 5 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183: 2 mg/m² IV olaparib 250 mg BID |
| Dose Level 6 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183: 2 mg/m² IV olaparib 300 mg BID |
| Dose Level 7 | Experimental | Drug: PM01183 + olaparibPM01183 + olaparib PM01183 3 mg/m² IV olaparib 300 mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients ≥18 years of age, no upper age limit.
- Written informed consent obtained prior to any study specific procedures or assessments.
- Histologically confirmed diagnosis of cancer:
- For patients included in the phase II part of the study, evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 is required.
- Patients included in the phase II part of the study must have received at least one line of standard therapy for locally advanced or metastatic disease, and developed progression disease afterwards.
Key exclusion criteria (19 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study.
- Previous enrolment or randomization in the present study.
- Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
- For patients included in the phase I of the study, previous treatment with olaparib or PM01183. For patients included in the phase II of the study, any previous treatment with a PARP inhibitor, including olaparib, or PM01183.
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 |
|---|---|---|
| PM01183 + olaparibAlso: Lynparza, Lurbinectedin | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7 |
Primary outcome
Dose limiting toxicity
Time frame: 1 year
To establish the Dose Limiting Toxicity in the dose escaltion study phase I
Maximum tolerated dose
Time frame: 1 year
To establish the Maximum tolerated dose in the dose escaltion study phase I
Efficacy in terms of Tumor Response Rate according to RECIST 1.1 criteria.
Time frame: 3 years
to assess the efficacy in terms of Tumor response rate according to RECIST 1.1 criteria of PM01183 in combination with olaparib in the selected populations
5 secondary outcomes
Pharmacodynamic evaluation to assess the increasing activity in DNA damage
Time frame: 1 year
Overall response rate
Time frame: 3 years
Progression free survival.
Time frame: 3 years
Biomarker analysis
Time frame: 3 years
To demonstrate the predictive capacity and prognostic impact of some of the biomarkers under study.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Andres Poveda, MD principal investigator
Fundación Instituto Valenciano de Oncología
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PM01183 + olaparib in people with Advanced Cancer and Ovarian Cancer, run by Poveda, Andrés, M.D. at 6 sites in Spain.
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 19 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: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andres Poveda, MD (0034961104647, apoveda@fivo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: 1 year). 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?
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 22 Jun 2017.