Metastatic Pancreatic CancerPhase 1/2NCT01130142
A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
A Phase 1/2 study testing IPI-926 plus gemcitabine in people with Metastatic Pancreatic Cancer, run by Infinity Pharmaceuticals, Inc. at 28 sites in 2 countries.
Trial summary
Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. 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?
- IPI-926 plus 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
- 122 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Apr 2010to May 2012
- Phase
- Phase 1/2
- 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
- 18 years of age
- Pathologically confirmed metastatic pancreatic adenocarcinoma
- At least 1 radiologically evaluable metastatic lesion (RECIST 1.1).
- ECOG 0 or 1
- Life expectancy ≥3 months.
- All women of child bearing potential, all sexually active male patients, and partners of patients must agree to use adequate methods of birth control
- Ability to adhere to the study visit schedule
- Voluntarily signed an informed consent form
Who cannot join
- Islet cell, acinar cell carcinoma, non-adenocarcinoma, (i.e., lymphoma, sarcoma), adenocarcinoma originated from biliary tree or cystadenocarcinoma
- Prior treatment with chemotherapy for pancreatic cancer.
- Known central nervous system metastases
- Inadequate hematologic function
- Inadequate hepatic function
- Inadequate renal function
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- External (percutaneous) biliary drain
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- Venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation not appropriately anticoagulated or have NCI CTCAE Grade 2 or greater bleeding episode in the 3 weeks prior to administration of IPI-926
- Concurrent administration of the medications or foods known to inhibit CYP3A activity to a clinically relevant degree
- Presence of active infection or systemic use of antibiotics within 72 hours of treatment
- Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study.
- Known human immunodeficiency virus (HIV) positivity
- Known hypersensitivity to gemcitabine, IPI-926, or their excipients
- Pregnant or lactating women
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Texas Oncology- Bedford
Bedford, Texas
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Texas Oncology, PA
Dallas, Texas, 75246
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
Institute of Translational Oncology Research
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Norton Health Care
Louisville, Kentucky, 40220
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
Virginia Oncology Associates
Newport News, Virginia, 23606
Kansas City Cancer Center
Overland Park, Kansas, 66210
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
Providence Portland Medical Center
Portland, Oregon, 97213
Rhode Island Hospital
Providence, Rhode Island
University of Rochester
Rochester, New York, 14604
South Texas Oncology and Hematology
San Antonio, Texas
University of California San Diego Medical Center
San Diego, California
University of California San Francisco
San Francisco, California
Seattle Cancer Care Alliance
Seattle, Washington, 98109
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Arizona Clinical Research Center
Tucson, Arizona, 85745
Tyler Cancer Center
Tyler, Texas, 75702
Kaiser Permanente
Vallejo, California, 94503
Canada3 sites
Jewish General Hospital
Montreal, Quebec
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Cancer Care Manitoba
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.
Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).
Read the detailed description
IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- IPI-926 plus gemcitabine, Placebo plus 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.
IPI-926 plus gemcitabineDrug
Also called IPI-926, Hedgehog pathway inhibitor, Hedgehog
Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
Placebo plus gemcitabineDrug
Also called Gemcitabine, Hedgehog, Hedgehog pathway inhibitor, Gemzar
Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Phase 2) | Active comparator | IPI-926 in combination with gemcitabine Receives: Drug: IPI-926 plus gemcitabine |
| Arm 2 (Phase 2) | Placebo comparator | Placebo in combination with gemcitabine Receives: Drug: IPI-926 plus gemcitabine; Drug: Placebo plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety profile including MTD
To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Measured: Once per week for 3 weeks of a 4 week cycle
Overall survival comparison
- To compare the overall survival (OS) of patients with previously untreated metastatic pancreatic cancer treated with IPI-926 plus gemcitabine or placebo plus gemcitabine.
- To evaluate the safety of IPI-926 plus gemcitabine or placebo plus gemcitabine.
Measured: An average of 6 months
Secondary outcomes (2)
Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine.
- To evalutate pharmacokinetics (PK) of IPI-926, gemcitabine, and their relevant metabolites.
Measured: During the 3rd week of the first 4 week cycle
Comparison of PFS, TTP and ORR
- To compare the progression free survival (PFS), time to progression (TTP) and overall response rate (ORR) of patients treated with IPI-926 plus gemcitabine or placebo plus gemcitabine.
Measured: An average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ross, MD, Study director, Infinity Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130142
- Sponsor's protocol ID
- IPI-926-03
- Status last verified
- Mar 2017
- First submitted
- 21 Apr 2010
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kochetkova M, Samuel MS. Differentiation of the tumor microenvironment: are CAFs the Organizer? Trends Cell Biol. 2022 Apr;32(4):285-294. doi: 10.1016/j.tcb.2021.11.008. Epub 2021 Dec 9.
PubMed 34895986
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01130142
- Acronym / sponsor ID
- IPI-926-03
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 May 2010 (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.
Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.
Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).
Detailed description
IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Phase 2) | Active comparator | Drug: IPI-926 plus gemcitabineIPI-926 in combination with gemcitabine |
| Arm 2 (Phase 2) | Placebo comparator | Drug: IPI-926 plus gemcitabine, Drug: Placebo plus gemcitabinePlacebo in combination with 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)
- 18 years of age
- Pathologically confirmed metastatic pancreatic adenocarcinoma
- At least 1 radiologically evaluable metastatic lesion (RECIST 1.1).
- ECOG 0 or 1
- Life expectancy ≥3 months.
Key exclusion criteria (15 listed)
- Islet cell, acinar cell carcinoma, non-adenocarcinoma, (i.e., lymphoma, sarcoma), adenocarcinoma originated from biliary tree or cystadenocarcinoma
- Prior treatment with chemotherapy for pancreatic cancer.
- Known central nervous system metastases
- Inadequate hematologic function
- Inadequate hepatic function
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 |
|---|---|---|
| IPI-926 plus gemcitabineAlso: IPI-926, Hedgehog pathway inhibitor, HedgehogDaily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle | Drug | Arm 1 (Phase 2), Arm 2 (Phase 2) |
| Placebo plus gemcitabineAlso: Gemcitabine, Hedgehog, Hedgehog pathway inhibitor, GemzarDaily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle | Drug | Arm 2 (Phase 2) |
Primary outcome
Evaluation of safety profile including MTD
Time frame: Once per week for 3 weeks of a 4 week cycle
To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.
Overall survival comparison
Time frame: An average of 6 months
* To compare the overall survival (OS) of patients with previously untreated metastatic pancreatic cancer treated with IPI-926 plus gemcitabine or placebo plus gemcitabine. * To evaluate the safety of IPI-926 plus gemcitabine or placebo plus gemcitabine.
2 secondary outcomes
Measurement of the maximum plasma concentration (Cmax) and area under the concentration versus time curve (AUC0-t) of IPI-926 and gemcitabine.
Time frame: During the 3rd week of the first 4 week cycle
Comparison of PFS, TTP and ORR
Time frame: An average of 6 months
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 6 Mar 2017.
- Derived from this study: PubMed 34895986Kochetkova M, Samuel MS. Differentiation of the tumor microenvironment: are CAFs the Organizer? Trends Cell Biol. 2022 Apr;32(4):285-294. doi: 10.1016/j.tcb.2021.11.008. Epub 2021 Dec 9.
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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.
Robert Ross, MD study director
Infinity Pharmaceuticals, Inc.
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPI-926 plus gemcitabine in people with Metastatic Pancreatic Cancer, run by Infinity Pharmaceuticals, Inc. at 28 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 15 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada. 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 combined 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.
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?
Evaluation of safety profile including MTD (time frame: Once per week for 3 weeks of a 4 week cycle). 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?
On the ClinicalTrials.gov record for NCT01130142, 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 6 Mar 2017.