Pancreatic NeoplasmsPhase 1NCT00529113
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
A Phase 1 study testing Bardoxolone methyl and Gemcitabine in people with Pancreatic Neoplasms and Pancreatic Cancer, run by Biogen at 5 sites in United States.
Trial summary
This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Pancreatic Cancer
- What is being tested?
- Bardoxolone methyl and Gemcitabine
- 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
- 33 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Sep 2007to 1 Nov 2009
- 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
- Phase I patients should have treatment naïve pancreatic cancer; however , Phase I patients who have had 1 prior regimen consisting of adjuvant chemo-radiation or adjuvant gemcitabine - as defined within the NCCN guidelines may be enrolled. Phase II patients must have metastatic disease (Stage IV only).
- Karnofsky performance status of >70%
- Adequate liver function. (total bilirubin ≤ 1.5 mg/dL and AST(SGOT) and ALT(SGPT) of < 2.5 ULN ( ≤ 5 ULN for Phase II patients with liver metastases), Serum Creatinine < 1.5 ULN
- Adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy. platelets ≥100,000/mm3, absolute neutrophil count (ANC) ≥1500/mm3, hemoglobin ≥9.0 g/dL, white blood cell (WBC) count ≥3000 /mm3
- Practice effective contraception during the entire study period.
- Life expectancy of more than 3 months.
- Able and willing to sign the informed consent form.
- Willing and able to self-administer orally and document all doses of RTA 402 ingested.
Who cannot join
- Prior treatment for current malignancy outside of the adjuvant setting for Phase I
- Inability to swallow tablets or capsules
- Active brain metastases or primary central nervous system (CNS) malignancies. (Patients with a previously treated brain metastasis may be included.)
- Active second malignancy
- Ten percent or greater weight loss over the 6 weeks before study entry.
- Pregnant or breast feeding
- Clinically significant illnesses which could compromise participation in the study, including, but not limited to: Uncontrolled diabetes; Active or uncontrolled infection; Acute or chronic liver disease; Confirmed diagnosis of Human immunodeficiency virus (HIV) infection; Uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia.
- Psychiatric illness that would limit compliance with study requirements.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sammons Cancer Center (US Oncology)
Dallas, Texas, 75246
Rocky Mountain Cancer Center (US Oncology)
Denver, Colorado
Central Indiana Cancer Centers (US Oncology)
Indianapolis, Indiana
Cancer Centers of Florida (US Oncology)
Ocoee, Florida
Northwest Cancer Specialist- Vancouver Cancer Specialist (US Oncology)
Vancouver, Washington
About this study
Official title: A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer
This study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer.
Read the detailed description
Phase I will be conducted to determine the MTD of RTA 402 (administered orally Days 1-21 or Days 1-28 of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle.
The phase II portion of the study will be randomized, and double-blinded. Phase II will utilize the RTA 402 MTD determined in Phase I; Arm 1 will consist of gemcitabine + RTA 402. RTA 402 capsules will administered orally Days 1-21 of each 28-day cycle (or Days 1-28 if appropriate, based on phase I results); gemcitabine (1000 mg/m2) will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle in each Arm. Arm 2 will consist of gemcitabine + placebo, placebo capsules will be taken orally Days 1-21 of each 28-day cycle (or Days 1-28 if appropriate, based on phase I results). Both treatment arms are 4-weeks in length.
The study was conceived with both a Phase I and Phase II portion as described above; however, only the Phase I portion was completed. The trial was terminated in 2009 before the Phase II portion could begin.
- Conditions
- Pancreatic Neoplasms, Pancreatic Cancer
- Being tested
- Bardoxolone methyl, Gemcitabine, Placebo
- Keywords
- pancreatic cancer, gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules (150 mg/day) for 21 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules (300 mg/day) for 21 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules (150 mg/day) for 28 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules (200 mg/day) for 28 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules (250 mg/day) for 28 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxlone methyl capsules (300 mg/day) x 28 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl capsules (350 mg/day) x 28 days
GemcitabineDrug
Also called Gemzar
1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15
PlaceboDrug
Placebo capsules x 28 days
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Cohort 1 | Experimental | Bardoxolone methyl 150 mg/day x 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 1 Cohort 2 | Experimental | Bardoxolone methyl 300 mg /day for 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 1 Cohort 3 | Experimental | Bardoxolone methyl 150 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 1 Cohort 4 | Experimental | Bardoxolone methyl 200 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 1 Cohort 5 | Experimental | Bardoxolone methyl 250 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 1 Cohort 6 | Experimental | Bardoxolone methyl 300 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 1 Cohort 7 | Experimental | Bardoxolone methyl 350 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Bardoxolone methyl; Drug: Gemcitabine |
| Phase 2 Cohort 1 | Experimental | Bardoxolone methyl maximum tolerated dose(as determined in the Phase 1 portion of the study)/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Gemcitabine; Drug: Bardoxolone methyl |
| Phase 2 Cohort 2 | Placebo comparator | Placebo capsules/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) Receives: Drug: Gemcitabine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.
Measured: End of trial
Phase II - To determine if treatment with RTA 402 in combination with gemcitabine can increase the progression-free survival versus gemcitabine plus placebo in patients with unresectable metastatic pancreatic cancer.
Measured: End of Trial
Secondary outcomes (6)
Phase I - To document any preliminary antitumor activity of RTA 402 in this patient population.
Measured: End ofTrial
Phase I - To characterize the pharmacokinetics (PK) of RTA 402 in this population.
Measured: End of Trial
Phase II - To determine the overall response rate in patients treated with RTA 402 + gemcitabine and in patients treated with gemcitabine + placebo.
Measured: End of Trial
Phase II - To determine the 1-year survival in this patient population.
Measured: End of Trial
Phase II - To determine the toxicities of these regimens.
Measured: End of Trial
Phase II - To determine the changes in quality of life (Functional Assessment of Chronic Illness Therapy (Fatigue), [FACIT-F]).
Measured: End of Trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study start30 Sep 2007
- Primary completion1 Nov 2009
- Study completion1 Nov 2009
Why it stopped: To pursue other indications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529113
- Sponsor's protocol ID
- 402-C-0702
- Status last verified
- May 2025
- First submitted
- 12 Sep 2007
- Last updated
- 29 May 2025
- Results posted
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Study With Gemcitabine and RTA 402 or Gemcitabine and Placebo for Patients With Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00529113
- Acronym / sponsor ID
- 402-C-0702
- Conditions
- Pancreatic Neoplasms, Pancreatic Cancer
- Keywords
- pancreatic cancer, gemcitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To pursue other indications
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2007 (actual)
- Primary completion
- 1 Nov 2009 (actual)
- Study completion
- 1 Nov 2009 (actual)
- First posted
- 14 Sep 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 study assesses the safety and efficacy of RTA 402 in combination with gemcitabine in patients with unresectable pancreatic cancer.
Detailed description
Phase I will be conducted to determine the MTD of RTA 402 (administered orally Days 1-21 or Days 1-28 of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle.
The phase II portion of the study will be randomized, and double-blinded. Phase II will utilize the RTA 402 MTD determined in Phase I; Arm 1 will consist of gemcitabine + RTA 402. RTA 402 capsules will administered orally Days 1-21 of each 28-day cycle (or Days 1-28 if appropriate, based on phase I results); gemcitabine (1000 mg/m2) will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle in each Arm. Arm 2 will consist of gemcitabine + placebo, placebo capsules will be taken orally Days 1-21 of each 28-day cycle (or Days 1-28 if appropriate, based on phase I results). Both treatment arms are 4-weeks in length.
The study was conceived with both a Phase I and Phase II portion as described above; however, only the Phase I portion was completed. The trial was terminated in 2009 before the Phase II portion could begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Cohort 1 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 150 mg/day x 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 1 Cohort 2 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 300 mg /day for 21 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 1 Cohort 3 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 150 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 1 Cohort 4 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 200 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 1 Cohort 5 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 250 mg/day for 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 1 Cohort 6 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 300 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 1 Cohort 7 | Experimental | Drug: Bardoxolone methyl, Drug: GemcitabineBardoxolone methyl 350 mg/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 2 Cohort 1 | Experimental | Drug: Gemcitabine, Drug: Bardoxolone methylBardoxolone methyl maximum tolerated dose(as determined in the Phase 1 portion of the study)/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
| Phase 2 Cohort 2 | Placebo comparator | Drug: Gemcitabine, Drug: PlaceboPlacebo capsules/day x 28 days and gemcitabine (1000 mg/m2 by intravenous infusion on Days 1, 9, and 15) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Phase I patients should have treatment naïve pancreatic cancer; however , Phase I patients who have had 1 prior regimen consisting of adjuvant chemo-radiation or adjuvant gemcitabine - as defined within the NCCN guidelines may be enrolled. Phase II patients must have metastatic disease (Stage IV only).
- Karnofsky performance status of >70%
- Adequate liver function. (total bilirubin ≤ 1.5 mg/dL and AST(SGOT) and ALT(SGPT) of < 2.5 ULN ( ≤ 5 ULN for Phase II patients with liver metastases), Serum Creatinine < 1.5 ULN
- Adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy. platelets ≥100,000/mm3, absolute neutrophil count (ANC) ≥1500/mm3, hemoglobin ≥9.0 g/dL, white blood cell (WBC) count ≥3000 /mm3
- Practice effective contraception during the entire study period.
Key exclusion criteria (8 listed)
- Prior treatment for current malignancy outside of the adjuvant setting for Phase I
- Inability to swallow tablets or capsules
- Active brain metastases or primary central nervous system (CNS) malignancies. (Patients with a previously treated brain metastasis may be included.)
- Active second malignancy
- Ten percent or greater weight loss over the 6 weeks before study entry.
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 |
|---|---|---|
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules (150 mg/day) for 21 days | Drug | Phase 1 Cohort 1 |
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules (300 mg/day) for 21 days | Drug | Phase 1 Cohort 2 |
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules (150 mg/day) for 28 days | Drug | Phase 1 Cohort 3 |
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules (200 mg/day) for 28 days | Drug | Phase 1 Cohort 4 |
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules (250 mg/day) for 28 days | Drug | Phase 1 Cohort 5 |
| Bardoxolone methylAlso: RTA 402Bardoxlone methyl capsules (300 mg/day) x 28 days | Drug | Phase 1 Cohort 6 |
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl capsules (350 mg/day) x 28 days | Drug | Phase 1 Cohort 7 |
| GemcitabineAlso: Gemzar1,000 mg/m2 administered as an intravenous infusion on days 1, 8, and 15 | Drug | Phase 1 Cohort 1, Phase 1 Cohort 2, Phase 1 Cohort 3, Phase 1 Cohort 4, Phase 1 Cohort 5, Phase 1 Cohort 6, Phase 1 Cohort 7, Phase 2 Cohort 1, Phase 2 Cohort 2 |
| PlaceboPlacebo capsules x 28 days | Drug | Phase 2 Cohort 2 |
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl maximum tolerated dose (as determined in the Phase 1 portion of the study)/day x 28 days | Drug | Phase 2 Cohort 1 |
Primary outcome
Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.
Time frame: End of trial
Phase II - To determine if treatment with RTA 402 in combination with gemcitabine can increase the progression-free survival versus gemcitabine plus placebo in patients with unresectable metastatic pancreatic cancer.
Time frame: End of Trial
6 secondary outcomes
Phase I - To document any preliminary antitumor activity of RTA 402 in this patient population.
Time frame: End ofTrial
Phase I - To characterize the pharmacokinetics (PK) of RTA 402 in this population.
Time frame: End of Trial
Phase II - To determine the overall response rate in patients treated with RTA 402 + gemcitabine and in patients treated with gemcitabine + placebo.
Time frame: End of Trial
Phase II - To determine the 1-year survival in this patient population.
Time frame: End of Trial
Phase II - To determine the toxicities of these regimens.
Time frame: End of Trial
Phase II - To determine the changes in quality of life (Functional Assessment of Chronic Illness Therapy (Fatigue), [FACIT-F]).
Time frame: End of Trial
Results and safety
The study was stopped early (reason given: To pursue other indications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bardoxolone methyl and Gemcitabine in people with Pancreatic Neoplasms and Pancreatic Cancer, run by Biogen at 5 sites 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 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 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 was stopped early (reason given: To pursue other indications). 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?
Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer. (time frame: End of trial). The study lists 2 primary outcomes in all. 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 29 May 2025.