Pancreatic CancerPhase 2RP101NCT00550004
Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
A Phase 2 study testing RP101 and Gemcitabine (1000 mg/m2) in people with Pancreatic Cancer, run by SciClone Pharmaceuticals at 55 sites in 13 countries.
Trial summary
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- RP101 and Gemcitabine (1000 mg/m2)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 55 sitesin 13 countries
- Study dates
- Sep 2007to Oct 2009
- Phase
- Phase 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
- Subjects must be 18 years of age or older
- Not previously treated with chemotherapy for Pancreatic Cancer
- ECOG performance status of 0 or 1
- Life expectancy > 3 months
- Documentation of all sites of pancreatic disease within 28 days prior to randomization
- Adequate hematological, renal, and hepatic function
- Not pregnant or nursing
- Fertile subjects must practice a medically approved method of contraception
Who cannot join
- Prior history of other malignant tumors
- Participation in another investigational study within 4 weeks prior to treatment start
- Major surgery within 14 days prior to treatment start
- Radiation treatment within 28 days prior to treatment start
- Uncontrolled cardiac atrial or ventricular arrhythmias
- Gastrointestinal tract disease such resulting in an inability to take oral medication
- Known to be seropositive for HIV, HBV, or HCV
- Uncontrolled cancer pain
Trial locations and contacts
55 sites in 13 countries.
55 sites in 13 countries
United States16 sites
St. Luke's Cancer Center
Bethlehem, Pennsylvania, 18015
Tower Research Foundation at Tower Oncology
Beverly Hills, California, 90211
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Gabrail Cancer Center
Canton, Ohio, 44718
Baylor College of Medicine
Houston, Texas, 77030
Integrated Community Oncology Network, LLC
Jacksonville, Florida, 32256
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042
Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center
Milwaukee, Wisconsin, 53226
Providence Portland Medical Center
Portland, Oregon, 97231
Utah Cancer Specialists
Salt Lake City, Utah, 84106
South Texas Oncology and Hematology, PA
San Antonio, Texas, 78207
University of California at San Francisco
San Francisco, California, 94110
University of Washington
Seattle, Washington, 98109-1023
Cancer Care Northwest
Spokane, Washington, 99202
University of Arizona Medical Center, Arizona Cancer Center
Tucson, Arizona, 85724
Brazil5 sites
Hospital de Caridade de Ijuí
Ijuí
Hospital de Clínicas de Porto Alegre, Serviço de Oncologia
Porto Alegre
Instituto Nacional do Câncer
Rio de Janeiro
Núcleo de Oncologia da Bahia
Salvador
Hospital do Câncer-AC Camargo
São Paulo
Spain5 sites
Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
Lleida
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid
Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil
Madrid
Instituto Valenciano de Oncología
Valencia
Hospital Universitario Miguel Servet
Zaragoza
Hungary4 sites
Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet
Budapest
Fovárosi Önkormányzat Uzsoki utcai Kórháza
Budapest
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék
Debrecen
Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia
Gyor, Budapest
Poland4 sites
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki
Jelenia Góra
I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej
Krakow
Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi
Lódz
Centrum Medyczne MRUKMED
Rzeszów
Romania4 sites
Institutul Clinic Fundeni
Bucharest
Institutul Oncologic 'Prof. Dr. A. Trestioreanu'
Bucharest
Spitalul Clinic de Urgenta Floreasca
Bucharest
Spitalul Clinic Universitar de Urgenta
Bucharest
Argentina3 sites
Hospital Italiano Regional del Sur
Bahía Blanca, Buenos Aires
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires
Hospital Zonal General de Agudos San Roque
La Plata, Buenos Aires
France3 sites
Hôpital Gabriel Montpied
Clermont-Ferrand
Centre Hospitalier Départemental
La Roche-sur-Yon
Centre Eugene Marquis, Service d'Oncologie Medicale
Rennes
Germany3 sites
Universitätsklinikum Dresden, Med. Klinik I
Dresden
Klinikum Region Hannover GmbH, Krankenhause Siloah
Hanover
Klinikum rechts der Isar, Technische Universität München
München
Peru3 sites
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria
Hospital Nacional Edgardo Rebagliati Martins
Lima
Instituto Oncocenter
San Borja
United Kingdom2 sites
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
Leicester, England
Mount Vernon Hospital
Middlesex, England
About this study
Official title: Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).
- Conditions
- Pancreatic Cancer
- Being tested
- RP101, Gemcitabine (1000 mg/m2)
- Keywords
- Unresectable, locally advanced, metastatic pancreatic adenocarcinoma, Stage III, Stage IV
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP101Drug
190 mg oral tablet
Gemcitabine (1000 mg/m2)Drug
Also called Gemzar
30 minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | RP101 and Gemcitabine Receives: Drug: RP101; Drug: Gemcitabine (1000 mg/m2) |
| Arm 2 | Placebo comparator | Placebo and Gemcitabine Receives: Drug: Gemcitabine (1000 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 18 months
Secondary outcomes (4)
Progression Free Survival
Measured: 14 months
Evaluate the CA 19-9 levels
Measured: 12 months
Compare changes in ECOG
Measured: 12 months
Evaluate Safety of RP101
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionOct 2009
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 Pancreatic 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manuel Hidalgo, MD, PhD, Study chair, Centro Integral de Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550004
- Sponsor's protocol ID
- SCI-RP-Pan-P2-001
- Acronym
- RP101
- Status last verified
- Oct 2009
- First submitted
- 25 Oct 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.
PubMed 21833720
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00550004
- Acronym / sponsor ID
- RP101 / SCI-RP-Pan-P2-001
- Conditions
- Pancreatic Cancer
- Keywords
- Unresectable, locally advanced, metastatic pancreatic adenocarcinoma, Stage III, Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Oct 2007 (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.
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: RP101, Drug: Gemcitabine (1000 mg/m2)RP101 and Gemcitabine |
| Arm 2 | Placebo comparator | Drug: Gemcitabine (1000 mg/m2)Placebo and Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be 18 years of age or older
- Not previously treated with chemotherapy for Pancreatic Cancer
- ECOG performance status of 0 or 1
- Life expectancy > 3 months
- Documentation of all sites of pancreatic disease within 28 days prior to randomization
Key exclusion criteria (8 listed)
- Prior history of other malignant tumors
- Participation in another investigational study within 4 weeks prior to treatment start
- Major surgery within 14 days prior to treatment start
- Radiation treatment within 28 days prior to treatment start
- Uncontrolled cardiac atrial or ventricular arrhythmias
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 |
|---|---|---|
| RP101190 mg oral tablet | Drug | Arm 1 |
| Gemcitabine (1000 mg/m2)Also: Gemzar30 minute intravenous infusion | Drug | Arm 1, Arm 2 |
Primary outcome
Overall Survival
Time frame: 18 months
4 secondary outcomes
Progression Free Survival
Time frame: 14 months
Evaluate the CA 19-9 levels
Time frame: 12 months
Compare changes in ECOG
Time frame: 12 months
Evaluate Safety of RP101
Time frame: 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 21833720Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.
- SciClone WebsiteLink provided by the sponsor.
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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.
Manuel Hidalgo, MD, PhD study chair
Centro Integral de Oncologia
55 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RP101 and Gemcitabine (1000 mg/m2) in people with Pancreatic Cancer, run by SciClone Pharmaceuticals at 55 sites in 13 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Brazil, Spain, Hungary, Poland and 8 more countries. 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. Some participants in this study may receive a placebo. 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 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?
The study was stopped early. Results are not available in the source record.
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?
Overall Survival (time frame: 18 months). 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 NCT00550004, 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 8 Jun 2011.