Metastatic Pancreatic CancerPhase 2NCT01028495
A Safety and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
A Phase 2 study testing RX-0201 plus Gemcitabine in people with Metastatic Pancreatic Cancer, run by Rexahn Pharmaceuticals, Inc. at 10 sites in 2 countries.
Trial summary
To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- RX-0201 plus Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2009to Aug 2012
- 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
- Provide written informed consent prior to the initiation of study procedures.
- Are > 18 years of age
- Have metastatic pancreatic cancer.
- Have at least 1 measurable lesion by RECIST criteria.
- Have a Karnofsky Performance Status of > 70.
- Have at least a 6-month life expectancy as assessed by the investigator.
- Pre-menopausal women must be surgically sterile or agree to use an accepted method of birth control while participating in the study and for 30 days following the last exposure of study drug. Acceptable forms of birth control are: hormonal contraceptives (oral, injectable, transdermal or implant), double-barrier contraceptives (condom or diaphragm with spermicide), and intrauterine device (IUD).
- Male subjects need to either be surgically sterile or agree to use a barrier method of birth control described above during the study and for 30 days following the last exposure to study drug. The subject's agreed upon method of birth control will be discussed and documented in the subjects source document during the screening phase of the study.
Who cannot join
- Are unwilling or unable to provide informed consent.
- Are unwilling or unable to comply with the requirements of the protocol.
- Have been treated with another investigational agent for pancreatic cancer.
- Have any of the following screening laboratory values:
- Hemoglobin < 8.0 grams/deciliter (g/dL)
- Absolute neutrophil count (ANC) < 1500/microliter (μL)
Show all 19Show fewer
- Platelet count < 100,000/μL
- Serum creatinine > 1.5 x the institutional upper limit of normal (IULN) creatinine.
- Serum bilirubin > 1.5 X IULN
- Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase, SGOT) > 2 x IULN (> 5 x IULN in presence of known liver metastasis)
- Alanine transaminase (ALT) (serum glutamate pyruvate transaminase, SGPT) > 2 x IULN (> 5 x IULN in presence of known liver metastasis)
- Have a prothrombin time >1.25 x IULN on screening laboratory assessments.
- HCV or HBsAg positive subjects
- Have received therapeutic dose of either warfarin or heparin within 21 days before Day 1 (the first day of dosing; prophylactic use of warfarin or heparin) to maintain patency of indwelling IV catheters/lines is allowed
- Have a history of brain cancer (primary or metastatic).
- Have a history of an active hematologic malignancy within the past 2 years.
- Have an underlying diagnosis or disease state associated with an increased risk of bleeding (i.e., coagulopathies, HIV).
- Have a serious infection requiring intravenous antibiotic therapy during screening.
- Females who are pregnant, lactating, or have a positive serum pregnancy test during the screening period.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
India6 sites
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, Kerala, 462 001
Meenakshi Mission Hospital and Research Center
Madurai-625020
Central India Cancer Research Institute
Maharashtra
Shatabdi Superspeciality Hospital
Maharashtra
Rajiv Gandhi Cancer Institute and Research Center
Rohini New- Delhi
King George Hospital
Visakhapatanam, A.P
United States4 sites
Texas Oncology
Austin, Texas, 78705
Baptist Cancer Institute
Jacksonville, Florida, 32207
Texas Oncology, P.A.
McAllen, Texas, 78705
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
About this study
Official title: A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer.
Read the detailed description
Subjects enrolled to assess safety will receive a combination of Gemcitabine plus RX-0201. Gemcitabine will be administered prior to RX-0201 intravenously in a 30-min iv infusion dose at 1000 mg/m2 once weekly for up to 2 cycles; each 4-week cycle consist of 3-week treatment phase followed by 1 week resting phase. RX-0201 will be administered at 250 mg/m2/day in a 24-hour continuous intravenous infusion for up to 2 cycles; each 3-week cycle consists of 2-week treatment phase followed by a 1 week resting phase. (See schedule of assessments)Subjects enrolled to evaluate efficacy will receive a combination of Gemcitabine and RX-0201 as outline above for up to 4 cycles.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- RX-0201 plus Gemcitabine
- Keywords
- AKT-1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-0201 plus GemcitabineDrug
RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off.
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine and RX-0201 | Experimental | Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off.
RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. Receives: Drug: RX-0201 plus Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 7 Months
Secondary outcomes (3)
Tumor Response
Measured: 8 weeks assessment and 16 weeks to confirm
Toxicity and Safety Parameters
Measured: Continuously
Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers
Measured: Every 14 Days and Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Tempero, M.D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028495
- Sponsor's protocol ID
- RX-0201-P2-A-07
- Status last verified
- Sep 2019
- First submitted
- 7 Dec 2009
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoon H, Kim DJ, Ahn EH, Gellert GC, Shay JW, Ahn CH, Lee YB. Antitumor activity of a novel antisense oligonucleotide against Akt1. J Cell Biochem. 2009 Nov 1;108(4):832-8. doi: 10.1002/jcb.22311.
PubMed 19693774Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3564
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Tolerability and Efficacy Study of RX-0201 Plus Gemcitabine in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01028495
- Acronym / sponsor ID
- RX-0201-P2-A-07
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- AKT-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rexahn Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Dec 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.
To assess the safety and efficacy of a combined therapy regimen of RX-0201 plus Gemcitabine, in subjects with metastatic pancreatic cancer.
Detailed description
Subjects enrolled to assess safety will receive a combination of Gemcitabine plus RX-0201. Gemcitabine will be administered prior to RX-0201 intravenously in a 30-min iv infusion dose at 1000 mg/m2 once weekly for up to 2 cycles; each 4-week cycle consist of 3-week treatment phase followed by 1 week resting phase. RX-0201 will be administered at 250 mg/m2/day in a 24-hour continuous intravenous infusion for up to 2 cycles; each 3-week cycle consists of 2-week treatment phase followed by a 1 week resting phase. (See schedule of assessments)Subjects enrolled to evaluate efficacy will receive a combination of Gemcitabine and RX-0201 as outline above for up to 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine and RX-0201 | Experimental | Drug: RX-0201 plus GemcitabineGemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off. RX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent prior to the initiation of study procedures.
- Are > 18 years of age
- Have metastatic pancreatic cancer.
- Have at least 1 measurable lesion by RECIST criteria.
- Have a Karnofsky Performance Status of > 70.
Key exclusion criteria (19 listed)
- Are unwilling or unable to provide informed consent.
- Are unwilling or unable to comply with the requirements of the protocol.
- Have been treated with another investigational agent for pancreatic cancer.
- Have any of the following screening laboratory values:
- Have received therapeutic dose of either warfarin or heparin within 21 days before Day 1 (the first day of dosing; prophylactic use of warfarin or heparin) to maintain patency of indwelling IV catheters/lines is allowed
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 |
|---|---|---|
| RX-0201 plus GemcitabineRX-0201 3 week cycle at 250mg/m2/day of continuous infusion for 14 days with 7 days off. Gemcitabine at 1000 mg/day once a week for a 4 week cycle; 3 weeks of treatment at 30 minutes infusion once a week and one week off. | Drug | gemcitabine and RX-0201 |
Primary outcome
Survival
Time frame: 7 Months
3 secondary outcomes
Tumor Response
Time frame: 8 weeks assessment and 16 weeks to confirm
Toxicity and Safety Parameters
Time frame: Continuously
Karnofsky Performance Scale, Clinical Laboratory Assessment, and Molecular Markers
Time frame: Every 14 Days and Study Completion
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 12 Sep 2019.
- Background: PubMed 19693774Yoon H, Kim DJ, Ahn EH, Gellert GC, Shay JW, Ahn CH, Lee YB. Antitumor activity of a novel antisense oligonucleotide against Akt1. J Cell Biochem. 2009 Nov 1;108(4):832-8. doi: 10.1002/jcb.22311.
- Results publicationJournal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 3564
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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.
Margaret Tempero, M.D study chair
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RX-0201 plus Gemcitabine in people with Metastatic Pancreatic Cancer, run by Rexahn Pharmaceuticals, Inc. at 10 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 8 inclusion and 19 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 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India, 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 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 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?
Survival (time frame: 7 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 NCT01028495, which also lists 2 linked publications.
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 12 Sep 2019.