Solid TumorsPhase 1NCT01724320
A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
A Phase 1 study testing OTX008 in people with Solid Tumors, run by Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously 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
- Solid Tumors
- What is being tested?
- OTX008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2012to May 2013
- 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
- Signed informed consent prior to beginning protocol specific screening procedures. Patients registered in this trial must be treated and followed at the participating centers. Patients should receive the study treatment within 7 days after registration
- Histologically proven malignant solid tumor
- Patients having failed all standard therapies, or for whom standard therapies are deemed ineffective or contra-indicated.
- Patients aged > 18 years.
- ECOG performance status (PS) of 0 to 1
- Off previous systemic therapy (except LH-RH agonist therapy started > 2 months prior to study entry that could be continued) , radiation therapy, or surgery for at least 30 days prior to first study treatment administration (45 days for bicalutamide).
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- Recovery from the toxic effects of prior treatment to NCIC-CTC grade < 1, except alopecia
- Adequate bone marrow function including: Neutrophils >= 1.5 x 10E9 /L; platelets >= 100 x 10E9 /L, Hb > 8g/dL without transfusion.
- Creatinine clearance >= 60 mL/min (Cockroft \& Gault formula, or MDRD formula for patients aged > 65 years).
- Adequate LFTs: Total bilirubin < 1 x the institutional upper normal limits (UNL); ALAT/ASAT >= 3 x UNL (or >= 5 x UNL in case of liver metastases).
- Serum albumin > 28g/L.
- Availability of the last tumor imaging within 6 months prior to baseline tumor imaging
- Availability of archived pathology specimen (paraffin-embedded block) from the tumor
Who cannot join
- History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval.
- Pregnant or lactating women or women of childbearing potential not using adequate contraception. Male patients not using adequate contraception.
- Tumor sites that necessitate immediate intervention (supportive care, surgery or radiation therapy) such as symptomatic brain or leptomeningeal tumor, spinal cord compression, other compressive tumor masses, painful bone metastasis, bone fracture, etc…
- Other serious illness or medical conditions, which, in the investigator's opinion could jeopardize patient's safety or hamper understanding of the study by the patient, patient's compliance to study treatment, or interpretation of study results. These conditions include (but are not restricted to):
- Congestive heart failure or angina pectoris not medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
- Existence of significant neurologic or psychiatric disorders impairing the ability to obtain consent.
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- Active infection.
- Concurrent treatment with other experimental therapies or participation in another clinical trial within 30 days prior to first study treatment administration.
- Concurrent treatment with any other anticancer therapy (except LH-RH agonist therapy initiated > 2 months prior to study entry).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Hopital Beaujon - AP-HP
Clichy, 92110
Eric RAYMOND, MD, +33 1 40 87 ext. 56 17, eric.raymond@bjn.aphp.fr
Eric RAYMOND, MD
- Recruiting
Institut Claudius Regaud
Toulouse, 31052
Jean-Pierre DELORD, MD, +33 5 67 22 ext. 25 67, delord.jean-pierre@claudiusregaud.fr
Jean-Pierre DELORD, MD
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1000
Ahmad AWADA, MD, +32 2 541 ext. 31 89, ahmad.awada@bordet.be
Ahmad AWADA, MD
About this study
The purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced solid tumors
Read the detailed description
Overexpression of galectin-1 protein is well documented in different types of cancers, with associated bad prognostic and enhanced metastases spreading.
In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and it was observed a blood vessels architecture normalization.
Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- OTX008
- Keywords
- solid tumors, first-in-man, phase I, cancer, galectin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX008Drug
OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day
| Study group | Role | What they receive |
|---|---|---|
| OTX008 | Experimental | Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day. Receives: Drug: OTX008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT) will be assessed during the first 21 days (3 weeks)of OTX008 treatment in each patient to determine Recommended Dose (RD)
Measured: up to 3 weeks of OTX008 treatment
Secondary outcomes (2)
Pharmacokinetics (PK)
OTX008 plasma concentration will be assessed at days 1, 2 and 22 of OTX008 treatment to determine PK profile of OTX008. Following parameters will be used: Trough (Cmin) and peak (Cmax) of OTX008 concentrations, Tmax, t1/2, steady state, total clearance, AUC (Area Under Curve)
Measured: Days 1, 2 and 22 of OTX008 treatment
Pharmacodynamics (PD)
Following parameter will be measured: plasma levels of galectin-1
Measured: Days 1 and 22 of OTX008 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724320
- Sponsor's protocol ID
- OTX008_101
- Status last verified
- Nov 2012
- First submitted
- 2 Nov 2012
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01724320
- Acronym / sponsor ID
- OTX008_101
- Conditions
- Solid Tumors
- Keywords
- solid tumors, first-in-man, phase I, cancer, galectin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 9 Nov 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.
The purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced solid tumors
Detailed description
Overexpression of galectin-1 protein is well documented in different types of cancers, with associated bad prognostic and enhanced metastases spreading.
In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and it was observed a blood vessels architecture normalization.
Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTX008 | Experimental | Drug: OTX008Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent prior to beginning protocol specific screening procedures. Patients registered in this trial must be treated and followed at the participating centers. Patients should receive the study treatment within 7 days after registration
- Histologically proven malignant solid tumor
- Patients having failed all standard therapies, or for whom standard therapies are deemed ineffective or contra-indicated.
- Patients aged > 18 years.
- ECOG performance status (PS) of 0 to 1
Key exclusion criteria (9 listed)
- History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval.
- Pregnant or lactating women or women of childbearing potential not using adequate contraception. Male patients not using adequate contraception.
- Tumor sites that necessitate immediate intervention (supportive care, surgery or radiation therapy) such as symptomatic brain or leptomeningeal tumor, spinal cord compression, other compressive tumor masses, painful bone metastasis, bone fracture, etc…
- Other serious illness or medical conditions, which, in the investigator's opinion could jeopardize patient's safety or hamper understanding of the study by the patient, patient's compliance to study treatment, or interpretation of study results. These conditions include (but are not restricted to):
- Concurrent treatment with other experimental therapies or participation in another clinical trial within 30 days prior to first study treatment administration.
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 |
|---|---|---|
| OTX008OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day | Drug | OTX008 |
Primary outcome
Dose Limiting Toxicity
Time frame: up to 3 weeks of OTX008 treatment
Dose Limiting Toxicity (DLT) will be assessed during the first 21 days (3 weeks)of OTX008 treatment in each patient to determine Recommended Dose (RD)
2 secondary outcomes
Pharmacokinetics (PK)
Time frame: Days 1, 2 and 22 of OTX008 treatment
Pharmacodynamics (PD)
Time frame: Days 1 and 22 of OTX008 treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTX008 in people with Solid Tumors, run by Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 3 sites in 2 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 13 inclusion and 9 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice HERAIT, MD (+33 6 85 12 ext. 00 18, pherait@phconsult-onco.com), 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: up to 3 weeks of OTX008 treatment). 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 9 Nov 2012.