A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
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| ClinicalTrials.gov Identifier: NCT01130142 |
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Recruitment Status :
Completed
First Posted : May 25, 2010
Last Update Posted : March 6, 2017
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Sponsor:
Infinity Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
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Brief 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. 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Pancreatic Cancer | Drug: IPI-926 plus gemcitabine Drug: Placebo plus gemcitabine | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 122 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1 (Phase 2)
IPI-926 in combination with gemcitabine
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Drug: IPI-926 plus gemcitabine
Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
Other Names:
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Placebo Comparator: Arm 2 (Phase 2)
Placebo in combination with gemcitabine
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Drug: IPI-926 plus gemcitabine
Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
Other Names:
Drug: Placebo plus gemcitabine Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle
Other Names:
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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]- To evalutate pharmacokinetics (PK) of IPI-926, gemcitabine, and their relevant metabolites.
- Comparison of PFS, TTP and ORR [ Time Frame: An average of 6 months ]- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130142
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Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
| Study Director: | Robert Ross, MD | Infinity Pharmaceuticals, Inc. |
| Responsible Party: | Infinity Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01130142 History of Changes |
| Other Study ID Numbers: |
IPI-926-03 |
| First Posted: | May 25, 2010 Key Record Dates |
| Last Update Posted: | March 6, 2017 |
| Last Verified: | March 2017 |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Veratrum Alkaloids Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antihypertensive Agents |