History of Changes for Study: NCT01647828

A Phase 1b/2 Study of OMP-59R5 in Combination With Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer (ALPINE)

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Study Record Versions

Version	Submitted Date	Changes
1	July 19, 2012	None (earliest Version on record)
2	July 23, 2012	Outcome Measures and Study Status
3	September 28, 2012	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	October 30, 2012	Contacts/Locations and Study Status
5	January 30, 2013	Contacts/Locations and Study Status
6	February 15, 2013	Study Status and Contacts/Locations
7	February 22, 2013	Contacts/Locations and Study Status
8	March 20, 2013	Arms and Interventions, Outcome Measures, Study Status, Study Identification and Study Description
9	May 16, 2013	Contacts/Locations and Study Status
10	August 16, 2013	Contacts/Locations and Study Status
11	February 7, 2014	Study Status and Contacts/Locations
12	June 23, 2014	Study Status and Contacts/Locations
13	July 14, 2014	Contacts/Locations and Study Status
14	August 29, 2014	Study Status and Contacts/Locations
15	December 3, 2014	Contacts/Locations and Study Status
16	March 11, 2015	Contacts/Locations and Study Status
17	January 25, 2016	Recruitment Status, Study Status and Contacts/Locations
18	March 7, 2016	Study Status
19	September 16, 2016	Recruitment Status, Study Status, Study Design
	Results Submission Events
March 12, 2018 October 23, 2019		Returned after QC review: April 9, 2018 Returned after QC review: November 13, 2019
20	January 19, 2023	Study Status, Outcome Measures, Study Identification, Results and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	59R5-002
Brief Title:	A Phase 1b/2 Study of OMP-59R5 in Combination With Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer (ALPINE)
Official Title:	A Phase 1b/2 Study of OMP-59R5 in Combination With Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
Secondary IDs:

Study Status


Record Verification:	July 2012
Overall Status:	Not yet recruiting
Study Start:	January 2013
Primary Completion:	January 2014 [Anticipated]
Study Completion:	September 2016 [Anticipated]

First Submitted:	July 11, 2012
First Submitted that Met QC Criteria:	July 19, 2012
First Posted:	July 24, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	July 19, 2012
Last Update Posted:	July 24, 2012 [Estimate]

Sponsor/Collaborators


Sponsor:	OncoMed Pharmaceuticals, Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description


Brief Summary:	The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with gemcitabine in subjects with previously untreated stage IV pancreatic cancer.
Detailed Description:

Conditions


Conditions:	Stage IV Pancreatic Cancer
Keywords:	Newly diagnosed Stage IV Pancreatic Cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	154 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: OMP-59R5 plus Gemcitibine OMP-59R5 plus Gemcitibine	Drug: OMP-59R5 OMP-59R5 administered intravenously Drug: Gemcitibine administered intravenously
Experimental: Gemcitibine plus Placebo Gemcitibine plus Placebo	Drug: Placebo administered IV

Outcome Measures


Primary Outcome Measures:
1.	Dose limiting toxicities (DLT) of OMP-59R5 in combination with gemcitabine [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (28 days), assessed up to 7 months ] The maximum tolerated dose (MTD) will be determined in patients treated with OMP-59R5 in combination with gemcitabine on Days 1, 8 and 15 of every 28-day cycle
2.	Progression-free survival (PFS) [ Time Frame: every 8 weeks till disease progression or start of new anti-cancer therapy, assessed up to 22 months ] If subjects experience unacceptable toxicities clearly related to one of the two drugs, they may continue the other drug alone until disease progression, or withdrawal of consent or unacceptable toxicity. Subjects who are discontinued from OMP-59R5 treatment will enter Follow-up period, be followed for survival and any subsequent anti-cancer therapies. Additionally, subjects who discontinue OMP-59R5 treatment for any reason other than disease progression will be followed with tumor assessment every 8 weeks/56 days
Secondary Outcome Measures:
1.	Pharmacokinetics (PK) of OMP-59R5 when given in combination with gemcitabine [ Time Frame: Up to 14 days after the first dose in Cycle 1, pre- and 5 minutes post- dose on Day 15 of Cycle 2, and Day 1 of every other cycle starting from Cycle 3, and up to 14 days after the last dose, assessed up to 24 months ] Apparent half life, AUC, clearance, volume of distribution
2.	Overall survival (OS), 6 months OS [ Time Frame: throughout the study and every 3 months after treatment discontinuation, assessed over 24 months ] Study visits are scheduled to occur every 7 (± 2) days for the first 3 weeks of each 4-week cycle. Survival follow-up information and subsequent anti-cancer therapies will be collected every 3 months until death, loss to follow-up, or study termination by the sponsor.
3.	Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every week during the first 3 weeks of a 4 week cycle, assessed over 24 months ] Safety and tolerability of OMP-59R5 in combination with gemcitabine in subjects with stage IV pancreatic cancer (Phase 1b and 2 portions in subjects receiving OMP-59R5 with gemcitabine)
4.	Overall response rate (ORR) [ Time Frame: Every 8 weeks assessed up to 24 months ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	90 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Subjects must meet all of the following major inclusion criteria to be eligible for the study: 18 years of age or older Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas. Performance Status (ECOG) 0 or 1 FFPE tumor tissue from metastatic site(s Adequate organ function Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration. Male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration. Exclusion Criteria: Subjects who meet any of the following major exclusion criteria will not be eligible for participation in the study: Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas. Known brain metastases. Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism). Any disorder that would significantly compromise protocol compliance. Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer. Known human immunodeficiency virus (HIV) infection. Females who are pregnant or breastfeeding.

Contacts/Locations


Central Contact Person:	Jakob Dupont, MA, MD Telephone: 650-995-8307 Email: jakob.dupont@oncomed.com
Study Officials:	Eileen M O'Reilly, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Locations:	United States, New York
	Memorial Sloan-Kettering Cancer Center New York, New York, United States, 10065 Contact:Contact: Eileen M O'Reilly, MD 646-888-4182 oreillye@mskcc.org Contact:Principal Investigator: Eileen M O'Reilly, MD

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