BridgeMD
New treatment option for Cancer
Official title The Drug Rediscovery Protocol (DRUP Trial)
ClinicalTrials.gov ID: NCT02925234
What this study is testing
What is Panitumumab?
Panitumumab is an investigational medicine, being studied as a potential treatment for cancer.
Also referred to as Vectibix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs\ prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult (age \>18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin...
- ECOG performance status 0-2
- Patients must have acceptable organ function as defined below. However, specific inclusion/
You likely can't join if
- specified in the drug-specific study manual will take precedence:
- Absolute neutrophil count ≥ 1.5 x 109/l
- Hemoglobin \> 5.6 mmol/l
- Platelets \> 75 x 109/l
- Total bilirubin \< 2 x ULN
- AST (SGOT) and ALT (SGPT) \< 2.5 x institutional ULN (or \< 5 x ULN in patients with known hepatic metastases)
See the full eligibility criteria
- Adult (age \>18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphomawith symptomatic disease progression or progression according to...
- ECOG performance status 0-2
- Patients must have acceptable organ function as defined below. However, specific inclusion/
- specified in the drug-specific study manual will take precedence:
- Absolute neutrophil count ≥ 1.5 x 109/l
- Hemoglobin \> 5.6 mmol/l
- Platelets \> 75 x 109/l
- Total bilirubin \< 2 x ULN
- AST (SGOT) and ALT (SGPT) \< 2.5 x institutional ULN (or \< 5 x ULN in patients with known hepatic metastases)
- Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
- Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for...
- Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR)...
- Patients must have a tumor profile for which treatment with one of the FDA and / or EMA approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on...
- new (obtained ≤2 months before inclusion, and without any type of anti-cancer therapy within those ≤2 months) fresh frozen tumor biopsy specimen for extensive biomarker testing is mandatory before the start of treatment...
- The fresh frozen tumor biopsy sample may be replaced by fresh frozen tumor tissue, obtained earlier from recurrent disease, as part of standard of care surgical procedure (i.e., performed at progression)
- If no fresh frozen tumor tissue is available for NGS, and the risk of obtaining a new tumor biopsy is considered too high, no biopsy will be required. In this case, the study coordinators must be informed in advance...
- Ability to understand and the willingness to sign a written informed consent document.
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Because of the risks of drug treatment to the developing foetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the...
- Ongoing toxicity \> grade 2, other than alopecia.
- Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception...
- Patients suffering from CRPC are allowed to continue androgen deprivation therapy.
- Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on...
- Patient is pregnant or nursing.
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in...
- Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to...
- No radiotherapy within the three months prior to the diagnosis of progression.
- No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
- Patients with known left ventricular ejection fraction (LVEF) \< 40% are not eligible
- Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance...
The study team makes the final eligibility decision.
Where it's taking place
- Alkmaar, Netherlands
- Almelo, Netherlands
- Amersfoort, Netherlands
- Amsterdam, Netherlands
- Apeldoorn, Netherlands
- Arnhem, Netherlands
- Breda, Netherlands
- Delft, Netherlands
- Deventer, Netherlands
- Drachten, Netherlands
- Ede, Netherlands
- Eindhoven, Netherlands
- Geleen, Netherlands
- Gorinchem, Netherlands
- Groningen, Netherlands
- Haarlem, Netherlands
- Hilversum, Netherlands
- Hoogeveen, Netherlands
- Leeuwarden, Netherlands
- Leiden, Netherlands
+ 10 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alkmaar, Netherlands; Almelo, Netherlands; Amersfoort, Netherlands; Amsterdam, Netherlands; Apeldoorn, Netherlands; Arnhem, Netherlands and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.