Pancreatic Ductal AdenocarcinomaPhase 2NCT01580397
Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
A Phase 2 study testing INNO-206 in people with Pancreatic Ductal Adenocarcinoma, run by ImmunityBio, Inc. at 6 sites in United States.
Trial summary
Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- INNO-206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 May 2012to 2 Jul 2013
- 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
- Age ≥ 18 years of age; male or female.
- Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic pancreatic ductal adenocarcinoma.
- Cancer progression after treatment with one gemcitabine and one fluoropyrimidine-containing chemotherapy regimen.
- Capable of providing informed consent and complying with trial procedures.
- ECOG performance status 0-1.
- Life expectancy ≥ 8 weeks.
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- Measurable tumor lesions according to RECIST 1.1 criteria.
- Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
- Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- Geographic accessibility to the site.
Who cannot join
- Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
- Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization.
- Exposure to any investigational agent within 30 days of Randomization.
- Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥ 5 years.
- Laboratory values: Screening serum creatinine > 1.5x upper limit of normal (ULN), alanine aminotransferase (ALT) > 3×ULN or > 5×ULN if liver metastases are present, total bilirubin > 3×ULN, absolute neutrophil count < 1,500/mm3, platelet concentration < 100,000/mm3, absolute lymphocyte count < 1000/mm3, hematocrit level < 27% for females or < 30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5×ULN, serum albumin ≤ 2.8 g/dL.
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- Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
- Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- History or signs of active coronary artery disease with or without angina pectoris.
- Serious myocardial dysfunction ultrasound-determined, with absolute left ventricular ejection fraction (LVEF) < 45% of predicted.
- History of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- Major surgery within 4 weeks prior to Randomization.
- Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- Any condition that is unstable and could jeopardize the subject's participation in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Medical College of Wisconsin - Division of Neoplastic Diseases and Related Disorders
Milwaukee, Wisconsin, 53266
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407-3799
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Sarcoma Oncology Center
Santa Monica, California, 90403
Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: A Multicenter, Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Subjects With Advanced or Unresectable Pancreatic Ductal Carcinoma Whose Tumors Have Progressed Following Prior Treatment
Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.
Read the detailed description
This is a phase 2 open-label, pilot study evaluating the preliminary efficacy and safety of INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Tumor response (complete and partial response and stable disease) will be monitored at Screening, then prior to cycles 3, 5 and 7, 3 weeks after cycle 8, then every 2 months to month 8 and every 3 months to tumor progression using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, and treatment will continue every 21 days until tumor progression is observed, 8 cycles of treatment are completed or unacceptable toxicity occurs. Progression-free survival [PFS], stable disease at 4 months and overall survival [OS] will be monitored as other primary objectives. PET/CT will be performed at Baseline and Week 9 to determine change in tumor metabolic activity, and CA 19-9 will be determined serially to assess potential tumor reduction. Subjects will visit the study site every 21 days for their IV infusions, at which time safety monitoring, including AEs, a directed physical examination, laboratory evaluations (serum chemistry, complete blood count [CBC], and urinalysis), vital signs, weight measurements, ECOG performance status and ECGs will be performed. Cardiac function will also be followed periodically using ECHOs.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- INNO-206
- Keywords
- Pancreatic cancer, INNO-206, Doxorubicin-EMCH
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNO-206Drug
Also called Aldoxorubicin
INNO-206 at a total dose of 350 mg/m2 (260 mg/m2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| INNO-206 | Experimental | INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles. Receives: Drug: INNO-206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective responses were evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (ie, improvements) in tumor measurements from baseline values were assigned a status of CR or PR or SD. Objective response measurements comprised the sum of CR plus PR.
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm).
Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
Measured: Approximately 12 months from enrollment
Secondary outcomes (1)
Number of Participants With Treatment-related Toxicities (Adverse Events)
The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in subjects with advanced or unresectable pancreatic ductal adenocarcinoma as measured by the frequency and severity of adverse events (AEs).
The following assessments were used to determine if subjects had adverse events:
vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) physical examination laboratory tests (chemistry, hematology, urinalysis, BSA) additionally, the following scans were performed to determine adverse events: ECHO / MUGA ECG
Measured: 30 days after last dose, up to 178 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study start16 May 2012
- Primary completion13 May 2013
- Study completion2 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Von Hoff, MD, FACP, Principal investigator, Translational Genomics Research InstituteDaniel Levitt, MD, PhD, Study director, CytRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580397
- Sponsor's protocol ID
- INNO-206-P2-PDA-01
- Status last verified
- Jun 2013
- First submitted
- 13 Apr 2012
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Subjects With Advanced or Unresectable Pancreatic Ductal Carcinoma Whose Tumors Have Progressed Following Prior Treatment
- ClinicalTrials.gov ID
- NCT01580397
- Acronym / sponsor ID
- INNO-206-P2-PDA-01
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic cancer, INNO-206, Doxorubicin-EMCH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2012 (actual)
- Primary completion
- 13 May 2013 (actual)
- Study completion
- 2 Jul 2013 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.
Detailed description
This is a phase 2 open-label, pilot study evaluating the preliminary efficacy and safety of INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles.
Tumor response (complete and partial response and stable disease) will be monitored at Screening, then prior to cycles 3, 5 and 7, 3 weeks after cycle 8, then every 2 months to month 8 and every 3 months to tumor progression using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, and treatment will continue every 21 days until tumor progression is observed, 8 cycles of treatment are completed or unacceptable toxicity occurs. Progression-free survival [PFS], stable disease at 4 months and overall survival [OS] will be monitored as other primary objectives. PET/CT will be performed at Baseline and Week 9 to determine change in tumor metabolic activity, and CA 19-9 will be determined serially to assess potential tumor reduction. Subjects will visit the study site every 21 days for their IV infusions, at which time safety monitoring, including AEs, a directed physical examination, laboratory evaluations (serum chemistry, complete blood count [CBC], and urinalysis), vital signs, weight measurements, ECOG performance status and ECGs will be performed. Cardiac function will also be followed periodically using ECHOs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INNO-206 | Experimental | Drug: INNO-206INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 8 consecutive cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years of age; male or female.
- Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic pancreatic ductal adenocarcinoma.
- Cancer progression after treatment with one gemcitabine and one fluoropyrimidine-containing chemotherapy regimen.
- Capable of providing informed consent and complying with trial procedures.
- ECOG performance status 0-1.
Key exclusion criteria (15 listed)
- Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
- Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization.
- Exposure to any investigational agent within 30 days of Randomization.
- Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥ 5 years.
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 |
|---|---|---|
| INNO-206Also: AldoxorubicinINNO-206 at a total dose of 350 mg/m2 (260 mg/m2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days. | Drug | INNO-206 |
Primary outcome
Objective Response Rate
Time frame: Approximately 12 months from enrollment
Objective responses were evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (ie, improvements) in tumor measurements from baseline values were assigned a status of CR or PR or SD. Objective response measurements comprised the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm). Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
1 secondary outcome
Number of Participants With Treatment-related Toxicities (Adverse Events)
Time frame: 30 days after last dose, up to 178 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Active, not recruitingPhase 1/2
A Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer
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RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
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RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
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.
Daniel Von Hoff, MD, FACP principal investigator
Translational Genomics Research Institute
Daniel Levitt, MD, PhD study director
CytRx
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INNO-206 in people with Pancreatic Ductal Adenocarcinoma, run by ImmunityBio, Inc. at 6 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 10 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 6 Jun 2024). 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?
Objective Response Rate (time frame: Approximately 12 months from enrollment). 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 Jun 2024.