Advanced Malignant Solid TumorsPhase 1NCT00884845
Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing PM02734 and erlotinib and Erlotinib in people with Advanced Malignant Solid Tumors, run by PharmaMar at 3 sites in 2 countries.
Trial summary
Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- PM02734 and erlotinib and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2009to Jun 2011
- 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
- Voluntary written informed consent form.
- Histologically or cytologically confirmed advanced malignant solid tumors.
- Measurable or non-measurable disease following (RECIST)
- Age ≥ 18 years.
- Life expectancy ≥ 3 months.
- Performance status ECOG ≤ 2.
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- Recovery from any drug-related adverse events (AEs) derived from previous treatments.
- Appropriate bone marrow, liver and renal function.
- Left ventricular ejection fraction (LVEF) within normal limits for the institution.
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment.
Who cannot join
- Prior therapy with PM02734.
- Pregnant or lactating women.
- Less than four weeks from radiation therapy.
- Evidence of progressive central nervous system (CNS) metastases. or any symptomatic brain or leptomeningeal metastases.
- Other relevant diseases or adverse clinical conditions.
- Any other major illness that, in the Investigator's judgment.
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- Limitation of the patient's ability to comply with the treatment or to follow-up at a participating protocol.
- Ingestion of potent cytochrome CYP3A4 inhibitors.
- Treatment with any investigational product in the 30-day period prior to the first infusion.
- Known hypersensitivity to any component of PM02734 or erlotinib.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Intituto Universitario Dexeus
Barcelona, Barcelona, 08020
United States1 site
Montefiore Medical Center
New York, New York, 10467-2490
About this study
Official title: Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.
Read the detailed description
Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, determine the preliminary pharmacokinetics (PK) of the combination, evaluate the preliminary PK/pharmacodynamic correlation, evaluate the preliminary antitumor activity, perform a preliminary pharmacogenomic (PGx) study to explore molecular predictors of response to ErbB receptor antagonists and PM02734 in patient with advanced malignant solid tumors.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- PM02734 and erlotinib, Erlotinib
- Keywords
- PM2734, Tumors, PharmaMar, Erlotinib, Tarceva
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM02734 and erlotinibDrug
PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion
ErlotinibDrug
Also called Brand name: TARCEVA
Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Administration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib Receives: Drug: PM02734 and erlotinib; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib
Measured: 2 years
Secondary outcomes (1)
To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Pérez-Soler, M.D., Principal investigator, Montefiore Medical Center (NY - USA)Rafael Rosell, M.D., Principal investigator, Hospital Universitario Germans Trias i Pujol (Badalona - Spain)Mauricio Cuello, M.D., Principal investigator, Instituto Universitario Dexeus (Barcelona - Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884845
- Sponsor's protocol ID
- PM2734-A-003-08
- Status last verified
- Mar 2014
- First submitted
- 16 Apr 2009
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT00884845
- Acronym / sponsor ID
- PM2734-A-003-08
- Conditions
- Advanced Malignant Solid Tumors
- Keywords
- PM2734, Tumors, PharmaMar, Erlotinib, Tarceva
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Apr 2009 (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 I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.
Detailed description
Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, determine the preliminary pharmacokinetics (PK) of the combination, evaluate the preliminary PK/pharmacodynamic correlation, evaluate the preliminary antitumor activity, perform a preliminary pharmacogenomic (PGx) study to explore molecular predictors of response to ErbB receptor antagonists and PM02734 in patient with advanced malignant solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PM02734 and erlotinib, Drug: ErlotinibAdministration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary written informed consent form.
- Histologically or cytologically confirmed advanced malignant solid tumors.
- Measurable or non-measurable disease following (RECIST)
- Age ≥ 18 years.
- Life expectancy ≥ 3 months.
Key exclusion criteria (10 listed)
- Prior therapy with PM02734.
- Pregnant or lactating women.
- Less than four weeks from radiation therapy.
- Evidence of progressive central nervous system (CNS) metastases. or any symptomatic brain or leptomeningeal metastases.
- Other relevant diseases or adverse clinical 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 |
|---|---|---|
| PM02734 and erlotinibPM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion | Drug | Arm 1 |
| ErlotinibAlso: Brand name: TARCEVAErlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets | Drug | Arm 1 |
Primary outcome
To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib
Time frame: 2 years
1 secondary outcome
To determine preliminary: pharmacokinetics (PK) , PK / pharmacodynamic correlation, antitumor activity, pharmacogenomic (PGx) study to explore molecular predictors of response.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Roman Pérez-Soler, M.D. principal investigator
Montefiore Medical Center (NY - USA)
Rafael Rosell, M.D. principal investigator
Hospital Universitario Germans Trias i Pujol (Badalona - Spain)
Mauricio Cuello, M.D. principal investigator
Instituto Universitario Dexeus (Barcelona - Spain)
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 PM02734 and erlotinib and Erlotinib in people with Advanced Malignant Solid Tumors, run by PharmaMar 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 26 Mar 2014. 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 Spain, United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib (time frame: 2 years). 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 26 Mar 2014.