Pancreatic CancerPhase 2NCT00536770
A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
A Phase 2 study testing calcitriol + gemcitabine and calcitriol + gemcitabine + erlotinib in people with Pancreatic Cancer, run by Novacea at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer. 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?
- calcitriol + gemcitabine and calcitriol + gemcitabine + erlotinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to not given
- 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
- Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer
- Performance status 0, 1,or 2
- Adequate bone marrow, renal and hepatic function
Who cannot join
- Prior chemotherapy or radiation therapy for pancreatic cancer
- Prior treatment for other cancers in last 6 months
- Cancer of the brain or spine
- Active uncontrolled infection
- Hypercalcemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- placebo + gemcitabine + erlotinib, Placebo + gemcitabine, calcitriol + gemcitabine, calcitriol + gemcitabine + erlotinib
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo + gemcitabine + erlotinibDrug
Placebo + gemcitabineDrug
calcitriol + gemcitabineDrug
calcitriol + gemcitabine + erlotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo + gemcitabine Receives: Drug: Placebo + gemcitabine |
| B | Placebo comparator | Placebo + gemcitabine + erlotinib Receives: Drug: placebo + gemcitabine + erlotinib |
| C | Active comparator | DN-101 + gemcitabine Receives: Drug: calcitriol + gemcitabine |
| D | Active comparator | DN-101 + gemcitabine + erlotinib Receives: Drug: calcitriol + gemcitabine + erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate at 6 months
Secondary outcomes (3)
Objective response rate
Duration of progression free survival
Duration of overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startSep 2007
Why it stopped: DSMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schering-Plough
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536770
- Sponsor's protocol ID
- 011-017
- Status last verified
- Nov 2007
- First submitted
- 26 Sep 2007
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00536770
- Acronym / sponsor ID
- 011-017
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: DSMB
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Collaborators
- Schering-Plough
- Study start
- Sep 2007
- First posted
- 28 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.
The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo + gemcitabinePlacebo + gemcitabine |
| B | Placebo comparator | Drug: placebo + gemcitabine + erlotinibPlacebo + gemcitabine + erlotinib |
| C | Active comparator | Drug: calcitriol + gemcitabineDN-101 + gemcitabine |
| D | Active comparator | Drug: calcitriol + gemcitabine + erlotinibDN-101 + gemcitabine + erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer
- Performance status 0, 1,or 2
- Adequate bone marrow, renal and hepatic function
Key exclusion criteria (5 listed)
- Prior chemotherapy or radiation therapy for pancreatic cancer
- Prior treatment for other cancers in last 6 months
- Cancer of the brain or spine
- Active uncontrolled infection
- Hypercalcemia
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 |
|---|---|---|
| placebo + gemcitabine + erlotinib | Drug | B |
| Placebo + gemcitabine | Drug | A |
| calcitriol + gemcitabine | Drug | C |
| calcitriol + gemcitabine + erlotinib | Drug | D |
Primary outcome
Overall survival rate at 6 months
3 secondary outcomes
Objective response rate
Duration of progression free survival
Duration of overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing calcitriol + gemcitabine and calcitriol + gemcitabine + erlotinib in people with Pancreatic Cancer, run by Novacea 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 3 inclusion and 5 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: paused, as of the sponsor's last update on 6 Nov 2007. 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. 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?
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 rate at 6 months. 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 6 Nov 2007; AzTrials last refreshed its copy on 7 Nov 2026.