Study of SUN-101 in Pancreatic Cancer

A Phase 1a/1b Study of SUN-101 in Subjects with Pancreatic Ductal Adenocarcinoma Previously Treated with Gemcitabine or FOLFIRINOX

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000991718

Enrollment

Registered

2013-09-05

Start date

2013-11-01

Completion date

2014-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The main goal of this study is to assess the safety and tolerability of the drug, SUN-101, in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic or locally advanced ductal adenocarcinoma of the pancreas, which has been previously treated with first line chemotherapy. Study details: Participants in the first part of this study (Phase 1a) will be administered SUN-101 in a dose-escalation scheme with cohorts of three patients at each dose level (1.0, 1.5 and 2.0 mg/kg). All cohorts will receive injections of SUN-101 once daily Monday through Friday, for 2 weeks, repeated every 4 weeks for up to 5 full cycles (up to 50 injections) depending on response. Participants in the second part of this study (Phase 1b) will be administered SUN-101 at the maximum tolerated dose identified in Phase 1a for up to 5 cycles. SUN-101 is a small molecule which is similar to a compound found naturally in human cells. Laboratory and animal studies suggest that SUN-101 targets and destroys the ductal cells in the pancreas where the tumour grows. Participants will be regularly assessed during treatment in order to assess safety and tolerability. Other goals of this study are to measure the levels of SUN-101 in the blood and urine over time and test whether SUN-101 can slow the growth of, or shrink tumours.

Interventions

SUN-101 During the 1a phase of the study, subjects will be enrolled in each of 3 cohorts sequentially: 1) cohort 1: SUN-101, 1.0 mg/kg subcutaneous, 3 subjects 2) cohort 2: SUN-101, 1.5 mg/kg subcutaneous, 3 subjects 3) cohort 3: SUN-101, 2.0 mg/kg subcutaneous, 3 subjects All cohorts will receive subcutaneous injections of SUN-101 once daily Monday through Friday, for 2 weeks, repeated every 4 weeks (2 weeks on, 2 weeks off is equal to 1 cycle). A total of (up to) 30 injections, or 3 planned full cycles (total of 12 weeks) will be administered in the absence of disease progression or unacceptable toxicity. In the event of a complete response according to the Response Evaluation Criteria in Solid Tumours (RECIST), one additional cycle will be administered. In the event of a RECIST stable disease or a partial response, subjects will continue to receive SUN-101 up to a total 5 cycles (up to 20 additional doses for a maximum total of 50 doses) of treatment until complete response, disease progression or unacceptable toxicity. An additional 24 evaluable subjects will be enrolled at the maximum tolerated dose identified in 1a to evaluate the efficacy and safety of SUN-101 at this recommended dose. Subjects in the phase 1b expansion study will receive SUN-101 subcutaneously on Monday through Friday for 2 weeks (10 doses per cycle) at the maximum tolerated dose (MTD) confirmed in Part 1a of this trial, repeated every 4 weeks (2 weeks on, 2 weeks off) for 3 cycles, and up to 5 cycles with partial response or stable disease, or until disease progression or unacceptable toxicity. If a dose is missed during the two weeks of dosing, it should be made up during the third week.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or cytologically confirmed metastatic or locally advanced ductal adenocarcinoma of the pancreas with CT scan measurable disease by RECIST criteria. 2. ECOG Performance Status 0 or 1 3. Received one, and only one, line of systemic therapy for their pancreatic locally advanced or metastatic pancreatic adenocarcinoma, including either: gemcitabine (with or without Abraxane, or another agent) or FOLFIRINOX or prior investigator-modified FOLFIRINOX regimen. 4. Adult, age greater than or equal to 18, male or female 5. Females of child-bearing potential must use investigator-approved method of contraception. All sexually active males must also use an investigator approved method of contraception. 6. Adequate bone marrow, hepatic, renal and coagulation function: 7. Adequate renal function, with calculated creatinine clearance greater than 50 mL/min using the Cockcroft and Gault equation 8. Willing and able to provide written informed consent

Exclusion criteria

1. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol 2. Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance 3. Presence of islet-cell or pancreatic neuroendocrine tumour or mixed adenocarcinoma-neuroendocrine carcinoma 4. Have symptomatic central nervous system (CNS) malignancy or metastasis. 5. Serum albumin levels less than 30 g/L 6. Life expectancy less than 12 weeks 7. Presence of known active bacterial, fungal, or viral infection requiring systemic therapy 8. Known infection with HIV, hepatitis B or C 9. Presence of congestive heart failure or symptomatic coronary artery disease, interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction 10. Lack of physical integrity of the upper gastrointestinal tract 11. Malabsorption syndrome pre-dating the diagnosis of pancreatic cancer. 12. Known, existing coagulopathy or receiving anticoagulants 13. Pregnant or lactating 14. Major surgery within 4 weeks of the start of study treatment, without complete recovery 15. Participation in any other clinical investigation within 4 weeks of enrolment

Outcome results