Pancreatic Ductal AdenocarcinomaPhase 2ASCENDNCT05042128
The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing LSTA1, Gemcitabine Injection and Nab paclitaxel in people with Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Cancer, run by Australasian Gastro-Intestinal Trials Group at 24 sites in 2 countries.
Trial summary
The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer
- What is being tested?
- LSTA1, Gemcitabine Injection and Nab paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 13 Apr 2022to 1 Oct 2025
- Phase
- Phase 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
- Adults, 18 years or older with histologically confirmed metastatic pancreatic ductal adenocarcinoma or poorly differentiated carcinoma.
- Measurable disease according to RECIST 1.1.
- Archival tumour tissue for tertiary correlative studies (biopsy or resection of primary or metastasis). Fine needle aspirate (FNA) or brushings will not be accepted.
- ECOG performance of 0-1 (Appendix 2)
- Adequate renal and haematological function
- Adequate hepatic function, defined as:
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- Bilirubin <1.5 X ULN (Upper Limit of Normal), AST or ALT ≤ 5x ULN. If a person was recently stented with improving bilirubin, the person can be randomised with bilirubin up to 3 x ULN provided chemotherapy is not administered until within the stated thresholds.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Study treatment both planned and able to start within 7 days after randomisation
- Signed, written informed consent.
Who cannot join
- Uncontrolled metastatic disease to the central nervous system. To be eligible, known CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time.
- Prior chemotherapy or investigational anti-cancer therapy for metastatic pancreatic adenocarcinoma. Prior treatments with curative intent or for locally advanced disease are allowed, provided the last dose of chemotherapy was administered more than 6 months prior to randomisation.
- Prior radiotherapy or major surgery (as defined by local investigator) within 14 days of starting treatment.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anti-cancer therapy with the exception of alopecia, vitiligo and the laboratory values defined in the inclusion criteria. Participants with Grade ≥2 peripheral neuropathy are not allowed.
- Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy or biological agents.
- Known allergy or hypersensitivity to any of the study drugs and excipients.
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- Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
- History of prior or synchronous malignancy within 2 years prior to randomisation, except:
- Malignancy that was treated with curative intent and for which there has been no known active disease for ≥2 years prior to randomisation.
- Curatively treated non-melanoma skin cancer, cervical cancer in situ, superficial transitional cell carcinoma of the bladder, stage 1 endometrial carcinoma, prostatic intraepithelial neoplasia, low-grade papillary thyroid cancer, untreated localised very low risk or low risk prostate cancer under observation.
- Concurrent illness, including severe infection that may jeopardise the ability of the person to undergo the procedures outlined in this protocol with reasonable safety.
- Neuroendocrine pancreatic carcinoma.
- Life expectancy of less than 3 months.
- Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomisation. Men must use a reliable means of contraception.
- Serious medical or psychiatric conditions that might limit the ability of the person to comply with the protocol.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Australia22 sites
Flinders Medical Centre
Adelaide, South Australia
Border Medical Oncology
Albury, New South Wales, 2640
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066
Sunshine Coast University Hospital
Birtinya, Queensland, 575
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, New South Wales, 3168
Northern Health
Epping, Victoria, 3076
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2290
Warringal Private Hospital
Heidelberg, Victoria, 3084
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
St George Hospital
Kogarah, New South Wales, 2217
Launceston General Hospital
Launceston, Tasmania
The Alfred Hospital
Melbourne, Victoria, 3004
Frankston Hospital
Melbourne, Victoria
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Calvary Mater Newcastle
Newcastle, New South Wales
Newcastle Private Hospital
Newcastle, New South Wales
Epworth Healthcare
Richmond, Victoria, 3121
ICON Cancer Centre, Gold Coast University Hospital
Southport, Queensland, 4215
St John of God
Subiaco, Western Australia, 6008
Prince of Wales Hospital
Sydney, New South Wales
Queen Elizabeth Hospital
Woodville South, South Australia, 5011
About this study
Official title: A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.
- Being tested
- LSTA1, Gemcitabine Injection, Nab paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSTA1Drug
Also called CEND-1, certepetide
LSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC
Gemcitabine InjectionDrug
Also called Gemzar
Chemotherapy drug provided as solution to be administered via IV infusion.
Nab paclitaxelDrug
Also called Abraxane
Chemotherapy drug provided as solution to be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Standard Care + LSTA1 (1 dose) | Experimental | Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. Receives: Drug: LSTA1; Drug: Gemcitabine Injection; Drug: Nab paclitaxel |
| Cohort A: Standard Care + Placebo | Placebo comparator | Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. Receives: Drug: Gemcitabine Injection; Drug: Nab paclitaxel |
| Cohort B: Standard Care +LSTA1 (2 doses) | Experimental | Participants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. Receives: Drug: LSTA1; Drug: Gemcitabine Injection; Drug: Nab paclitaxel |
| Cohort B: Standard Care + Placebo | Placebo comparator | Participants will receive nab-paclitaxel 125mg/m2; placebo IV; Gemcitabine 1000mg/m2, and then +~4hrs matching placebo IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. Receives: Drug: Gemcitabine Injection; Drug: Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
Measured: From date of randomization to 18 months later, or death
Secondary outcomes (5)
Overall Survival
Period of time from randomization to date of death from any cause, or the date of last known follow-up alive
Measured: From date of randomization to 18 months later, or death
Objective Tumour Response Rate
The number of participants with documented partial or complete response (PR or CR) divided by the number of participants evaluable for response as defined as per the RECIST version 1.1 criteria
Measured: From date of randomization to 18 months later, or death
Patient-reported Outcomes
Completion of the EORTC QLQ-C30 questionnaire. 30 questions; 28 on a 1-4 scale (Higher scores indicative of poorer quality of life), 2 on a 1-7 scale (higher scores indicative of better health/quality of life).
Measured: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Patient-reported Outcomes
Completion of the QLQ-PAN26 questionnaire. 26 questions on a 1-4 scale (Higher scores indicative of poorer quality of life)
Measured: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Incidence of Treatment-Emergent Adverse Events (Patient Safety)
Record of all adverse events (including SAEs) that patients experience
Measured: From date of randomization until 30 days after final treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start13 Apr 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
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 Pancreatic Ductal AdenocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Sponsor type
- Research network
- Collaborators
- University of Sydney
- Responsible party
- Sponsor
- Investigators
- Andrew Dean, Study chair, St John of God HospitalTimothy Price, Study chair, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042128
- Sponsor's protocol ID
- CTC0304
- Acronym
- ASCEND
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dean A, Gill S, McGregor M, et al. 1528P Phase I trial of the first-in-class agent CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer. Annals of Oncology 2020; 31: S941.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05042128
- Acronym / sponsor ID
- ASCEND / CTC0304
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Australasian Gastro-Intestinal Trials GroupResearch network
- Collaborators
- University of Sydney
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Sep 2021 (actual)
- 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.
The purpose of the ASCEND clinical trial is to measure the effect of adding LSTA1 (certepetide), compared to placebo, to chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. The study will assess the duration which the cancer remained stable or improved, the number of patients who responded to treatment, overall survival, side effects and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Standard Care + LSTA1 (1 dose) | Experimental | Drug: LSTA1, Drug: Gemcitabine Injection, Drug: Nab paclitaxelParticipants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. |
| Cohort A: Standard Care + Placebo | Placebo comparator | Drug: Gemcitabine Injection, Drug: Nab paclitaxelParticipants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. |
| Cohort B: Standard Care +LSTA1 (2 doses) | Experimental | Drug: LSTA1, Drug: Gemcitabine Injection, Drug: Nab paclitaxelParticipants will receive nab-paclitaxel 125mg/m2; LSTA1 3.2mg/kg IV; Gemcitabine 1000mg/m2, and then +~4hrs LSTA1 3.2mg/kg IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. |
| Cohort B: Standard Care + Placebo | Placebo comparator | Drug: Gemcitabine Injection, Drug: Nab paclitaxelParticipants will receive nab-paclitaxel 125mg/m2; placebo IV; Gemcitabine 1000mg/m2, and then +~4hrs matching placebo IV on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults, 18 years or older with histologically confirmed metastatic pancreatic ductal adenocarcinoma or poorly differentiated carcinoma.
- Measurable disease according to RECIST 1.1.
- Archival tumour tissue for tertiary correlative studies (biopsy or resection of primary or metastasis). Fine needle aspirate (FNA) or brushings will not be accepted.
- ECOG performance of 0-1 (Appendix 2)
- Adequate renal and haematological function
Key exclusion criteria (15 listed)
- Uncontrolled metastatic disease to the central nervous system. To be eligible, known CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time.
- Prior chemotherapy or investigational anti-cancer therapy for metastatic pancreatic adenocarcinoma. Prior treatments with curative intent or for locally advanced disease are allowed, provided the last dose of chemotherapy was administered more than 6 months prior to randomisation.
- Prior radiotherapy or major surgery (as defined by local investigator) within 14 days of starting treatment.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anti-cancer therapy with the exception of alopecia, vitiligo and the laboratory values defined in the inclusion criteria. Participants with Grade ≥2 peripheral neuropathy are not allowed.
- Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy or biological agents.
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 |
|---|---|---|
| LSTA1Also: CEND-1, certepetideLSTA1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC | Drug | Cohort A: Standard Care + LSTA1 (1 dose), Cohort B: Standard Care +LSTA1 (2 doses) |
| Gemcitabine InjectionAlso: GemzarChemotherapy drug provided as solution to be administered via IV infusion. | Drug | Cohort A: Standard Care + LSTA1 (1 dose), Cohort A: Standard Care + Placebo, Cohort B: Standard Care + Placebo, Cohort B: Standard Care +LSTA1 (2 doses) |
| Nab paclitaxelAlso: AbraxaneChemotherapy drug provided as solution to be administered via IV infusion. | Drug | Cohort A: Standard Care + LSTA1 (1 dose), Cohort A: Standard Care + Placebo, Cohort B: Standard Care + Placebo, Cohort B: Standard Care +LSTA1 (2 doses) |
Primary outcome
Progression Free Survival
Time frame: From date of randomization to 18 months later, or death
Period of time from randomization to the date of first evidence of disease progression, the occurrence of new disease or death from any cause
5 secondary outcomes
Overall Survival
Time frame: From date of randomization to 18 months later, or death
Objective Tumour Response Rate
Time frame: From date of randomization to 18 months later, or death
Patient-reported Outcomes
Time frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Patient-reported Outcomes
Time frame: Completed at baseline, then every 8 weeks from randomization until and at disease progression (to a maximum of 48 months).
Incidence of Treatment-Emergent Adverse Events (Patient Safety)
Time frame: From date of randomization until 30 days after final treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- BackgroundDean A, Gill S, McGregor M, et al. 1528P Phase I trial of the first-in-class agent CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer. Annals of Oncology 2020; 31: S941.
- Individual participant dataSharing planned: No
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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.
Andrew Dean study chair
St John of God Hospital
Timothy Price study chair
The Queen Elizabeth Hospital
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LSTA1, Gemcitabine Injection and Nab paclitaxel in people with Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Cancer, run by Australasian Gastro-Intestinal Trials Group at 24 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 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Australia, New Zealand. 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 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?
Results are not available in the source record.
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 (time frame: From date of randomization to 18 months later, or death). 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 NCT05042128, 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 22 Oct 2024.