Solid TumorsPhase 1NCT01299636
Study of PM060184 in Patients With Advanced Solid Tumors
A Phase 1 study testing PM060184 in people with Solid Tumors, run by PharmaMar at 1 site in United States.
Trial summary
The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184. 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?
- PM060184
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2015
- 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 signed and dated written informed consent.
- Patients with advanced solid tumors refractory to Standard therapy.
- Age >/= 18 years.
- Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
- Normal laboratory values within seven days prior to treatment administration.
- 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
- Pregnant or lactating women.
- Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
- Prior treatment with any investigational product less than 30 days prior to the first.
- Central Nervous System metastases
- Other relevant diseases or adverse clinical conditions:
- Increased cardiac risk:
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- Presence of significant neurological or psychiatric disorders
- Neuropathy
- Active infection requiring treatment.
- Liver disease (e.g., cirrhosis, hepatitis).
- Immunocompromised patients.
- Any other major illness.
- Limitation of the patient's ability to comply with the treatment.
- Known hypersensitivity to any of the components of the drug product.
Trial locations and contacts
1 site in 1 country.
United States1 site
START- South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
About this study
Official title: Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.
Read the detailed description
This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- PM060184
- Keywords
- PM060184, Phase I, Pharma Mar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM060184Drug
PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| PM060184 | Experimental | Not described Receives: Drug: PM060184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.
Measured: From treatment onset to end of treatment
Secondary outcomes (2)
To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.
The complete plasma concentration-time profiles of PM06184 will be analyzed by standard non-compartmental methods.The percent of PM060184 total dose excreted unchanged into the urine over the collection interval will be calculated from the urine samples.
Measured: Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.
Antitumor activity
Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers
Measured: Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyriakos Papadopoulos, MD, Principal investigator, START- South Texas Accelerated Research Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299636
- Sponsor's protocol ID
- PM60184-A-002-10
- Status last verified
- Oct 2015
- First submitted
- 9 Feb 2011
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghalib MH, Pulla MP, De Miguel Luken MJ, de Juan VC, Chaudhary I, Hammami MB, Vikash S, Maitra R, Martinez S, Kahatt C, Extremera S, Fudio S, Goel S. A phase I safety and efficacy clinical trial of plocabulin and gemcitabine in patients with advanced solid tumors. Invest New Drugs. 2024 Oct;42(5):481-491. doi: 10.1007/s10637-024-01458-8. Epub 2024 Aug 3.
PubMed 39096398
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. 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 Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01299636
- Acronym / sponsor ID
- PM60184-A-002-10
- Conditions
- Solid Tumors
- Keywords
- PM060184, Phase I, Pharma Mar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Feb 2011 (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 the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.
Detailed description
This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM060184 | Experimental | Drug: PM060184 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary signed and dated written informed consent.
- Patients with advanced solid tumors refractory to Standard therapy.
- Age >/= 18 years.
- Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia.
- Normal laboratory values within seven days prior to treatment administration.
Key exclusion criteria (14 listed)
- Pregnant or lactating women.
- Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
- Prior treatment with any investigational product less than 30 days prior to the first.
- Central Nervous System 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 |
|---|---|---|
| PM060184PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days. | Drug | PM060184 |
Primary outcome
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
Time frame: From treatment onset to end of treatment
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.
2 secondary outcomes
To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.
Time frame: Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.
Antitumor activity
Time frame: Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.
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 2 Nov 2015.
- Derived from this study: PubMed 39096398Ghalib MH, Pulla MP, De Miguel Luken MJ, de Juan VC, Chaudhary I, Hammami MB, Vikash S, Maitra R, Martinez S, Kahatt C, Extremera S, Fudio S, Goel S. A phase I safety and efficacy clinical trial of plocabulin and gemcitabine in patients with advanced solid tumors. Invest New Drugs. 2024 Oct;42(5):481-491. doi: 10.1007/s10637-024-01458-8. Epub 2024 Aug 3.
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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.
Kyriakos Papadopoulos, MD principal investigator
START- South Texas Accelerated Research Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PM060184 in people with Solid Tumors, run by PharmaMar at 1 site in United States.
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 6 inclusion and 14 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184. (time frame: From treatment onset to end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01299636, which also lists 1 linked publication.
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 2 Nov 2015.