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Pancreatic AdenocarcinomaPhase 2NCT01144455

Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

A Phase 2 study testing Gemzar (Gemcitabine) and TH-302 in people with Pancreatic Adenocarcinoma, run by ImmunoGenesis at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Gemzar (Gemcitabine) and TH-302
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
59 sitesUnited States
Study dates
Jun 2010to Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • At least 18 years of age
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
  • Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven either by histology or cytology previously untreated with chemotherapy or systemic therapy other than:
  • Radiosensitizing doses of 5-fluorouracil;
  • Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
  • Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
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  • Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy.
  • Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields)
  • Documentation of disease progression since any prior therapy
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Acceptable liver function:
  • Bilirubin less than or equal to 1.5 times upper limit of normal
  • AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times upper limit of normal (ULN); if liver metastases are present, then less than or equal to 5 times ULN is allowed
  • Acceptable renal function:
  • Serum creatinine less than or equal to ULN
  • Acceptable hematologic status (without hematologic support):
  • ANC greater than or equal to 1500 cells/μL
  • Platelet count greater than or equal to 100,000/μL
  • Hemoglobin greater than or equal to 9.0 g/dL
  • All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose

Who cannot join

  • New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
  • Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
  • Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
  • Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
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  • Treatment of pancreatic cancer with radiation therapy or surgery within 4 weeks prior to study entry
  • Prior therapy with an hypoxic cytotoxin
  • Subjects who participated in an investigational drug or device study within 28 days prior to study entry
  • Known active infection with HIV, hepatitis B, or hepatitis
  • Subjects who have exhibited allergic reactions to a structural compound, biological agent, or formulation (containing solutol and/or propylene glycol) similar to TH- 302
  • Females who are pregnant or breast-feeding
  • Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Unwillingness or inability to comply with the study protocol for any reason

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Cancer Care of Western North Carolina, PA

    Asheville, North Carolina, 28801

  • Atlanta Cancer Care

    Atlanta, Georgia, 30342

  • Medical Oncology

    Baton Rouge, Louisiana, 70809

  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35223

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Disney Family Cancer Center

    Burbank, California, 91505

  • Alamance Oncology Hematolgy Associates

    Burlington, North Carolina, 27599

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Providence Everett Regional Medical Center, Cancer Research Dept.

    Everett, Washington, 98201

  • Fairfax Northern Virginia Hematology Oncology, PC

    Fairfax, Virginia, 22031

  • Saint Edward Mercy Medical Center

    Fort Smith, Arkansas, 72917

  • Texas Oncology- Fort Worth - 12th Avenue

    Fort Worth, Texas, 76104

  • Institute for Translational Oncology Research (ITOR)

    Greenville, South Carolina, 29605

  • Carolina Oncology Specialists, PA

    Hickory, North Carolina, 28602

  • Emerywood Hematology and Oncology

    High Point, North Carolina, 27262

  • New York Oncology Hematology, P.C.

    Hudson, New York, 12534

  • Indiana University Melvin and Bren Simon Cancer

    Indianapolis, Indiana, 46202

  • Columbia Basin Hematology and Oncology0

    Kennewick, Washington, 99336

  • Scripps Clinical Research Services

    La Jolla, California, 92037

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Virgina Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Montana Cancer Institute Foundation

    Missoula, Montana, 59802

  • Palo Alto Medical Foundation

    Mountain View, California, 94040

  • Vanderbilt University Medical Center, Div. of Medical Oncology

    Nashville, Tennessee, 37232

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121

  • Florida Cancer Institute - New Hope

    New Port Richey, Florida, 34655

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • Purchase Cancer Group

    Paducah, Kentucky, 42002

  • Greater Philadelphia Cancer and Hematology Specialists, P.C.

    Philadelphia, Pennsylvania, 19114

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Kaiser Permanente Northwest Region Oncology Hematology

    Portland, Oregon, 97227

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Texas Oncology-Seton Williamson

    Round Rock, Texas, 78665

  • Los Palos Oncology and Hematology

    Salinas, California, 93901

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Texas Oncology-Sherman

    Sherman, Texas, 75090

  • LSU Health Sciences Center - Feist Weiller Cancer Center

    Shreveport, Louisiana, 71130

  • Hematology Oncology Associates, PC

    Stamford, Connecticut, 06902

  • Martin Memorial Cancer Center

    Stuart, Florida, 34994

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • University of Arizona

    Tucson, Arizona, 85724

  • Hematology and Oncology Associates at BridgePoint

    Tupelo, Mississippi, 38801

  • Carle Cancer Center

    Urbana, Illinois, 61901

  • Texas Oncology-Wichita Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Randomized Cross-over Phase 2 Study of the Safety and Efficacy of Two Dose Levels of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma.

Read the detailed description

A hypoxic microenvironment is a characteristic of many solid tumors including pancreatic cancer. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively physiologically target the hypoxic microenvironment. There is an absence of therapeutic options for subjects with metastatic pancreatic cancer. Gemcitabine provides clinical benefit as a single agent, but median survival is about 6 months. Combining gemcitabine with TH-302 may enable the targeting of both the normoxic and hypoxic regions of pancreatic cancer.

Being tested
Gemzar (Gemcitabine), TH-302
Keywords
Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemzar (Gemcitabine)Drug

    Also called Gemcitabine

    1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

  • TH-302Drug

    Also called HAP, hypoxia activated prodrug

    240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

  • TH-302Drug

    Also called HAP, hypoxia activated prodrug

    340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Study groups in NCT01144455
Study groupRoleWhat they receive
GemcitabineActive comparatorGemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Receives: Drug: Gemzar (Gemcitabine)
240 mg/m2 TH-302 + GemcitabineExperimentalTH-302: 240 mg/m2 administered IV over 30 minutes Day 1, 8, and 15 of each 28-day cycle Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Receives: Drug: Gemzar (Gemcitabine); Drug: TH-302
340 mg/m2 TH-302 + GemcitabineExperimentalTH-302: 340 mg/m2 of TH-302 be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle. Gemcitabine: 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle
Receives: Drug: Gemzar (Gemcitabine); Drug: TH-302

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionSep 2013
  4. Study completionDec 2014

Resources

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
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144455
Sponsor's protocol ID
TH-CR-404
Status last verified
May 2025
First submitted
11 Jun 2010
Last updated
11 May 2025
Data monitoring committee
Yes

Publications

  • Borad MJ, Reddy SG, Bahary N, Uronis HE, Sigal D, Cohn AL, Schelman WR, Stephenson J Jr, Chiorean EG, Rosen PJ, Ulrich B, Dragovich T, Del Prete SA, Rarick M, Eng C, Kroll S, Ryan DP. Randomized Phase II Trial of Gemcitabine Plus TH-302 Versus Gemcitabine in Patients With Advanced Pancreatic Cancer. J Clin Oncol. 2015 May 1;33(13):1475-81. doi: 10.1200/JCO.2014.55.7504. Epub 2014 Dec 15.

    PubMed 25512461

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemzar (Gemcitabine) and TH-302 in people with Pancreatic Adenocarcinoma, run by ImmunoGenesis at 59 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 21 inclusion and 14 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 11 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 59 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. 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?

Yes. Results are posted in the registry (first posted 25 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year). 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 NCT01144455, 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 11 May 2025.

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