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Pancreatic CancerPhase 1/2SAVIORNCT00898287

Safety and Efficacy Study of P276-00 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

A Phase 1/2 study testing P276-00 and Gemcitabine in people with Pancreatic Cancer, run by Piramal Enterprises Limited at 7 sites in India.

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 identify a dose of P276-00 that can be safely administered along with Gemcitabine and to examine safety and efficacy of the combination in treatment of advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
P276-00 and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
7 sitesIndia
Study dates
May 2009to Dec 2010
Phase
Phase 1/2
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

  • Histologically or cytologically confirmed diagnosis of infiltrating ductal adenocarcinoma of pancreas.
  • Chemonaive patients i.e. patients must not have received chemotherapy or biologic/targeted anticancer therapy for the adenocarcinoma of pancreas.
  • Locally advanced inoperable pancreatic cancer.
  • Patients of either sex, aged > or = 18 years.
  • Karnofsky performance status of > or = 60%.
  • Adequate bone marrow reserve: white blood cell (WBC) count > or = 4 x 109/l, Absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelets > or = 100 x 109/l, hemoglobin > or = 10 g/dl.
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  • Adequate liver function: bilirubin < or = 1.5 times the upper normal value, ALT/AST/ alkaline phosphatase less than 3 times the upper normal value (unless due to liver metastases in which case bilirubin less than 3 times the upper normal value, ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit).
  • Adequate renal function: creatinine ≤ 1.5 times the upper normal value.
  • If female:
  • Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of at least 2 approved contraceptive methods (at least one should be a barrier method) during and for 4 weeks after stopping the study treatment.
  • Negative urine β-HCG test within 1 week prior to protocol entry where childbearing potential is not terminated.
  • Additional inclusion criterion only for part B: Patient should satisfy at least one of the following criteria on cycle 1 day 1:
  • Karnofsky performance status of 60 or 70
  • Baseline pain intensity score of > or = 20 mm

Who cannot join

  • Inability / unwillingness to give consent.
  • Pregnant or breast feeding women.
  • Brain metastasis (active or inactive).
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
  • Patients known to be suffering from infection with HIV, Hepatitis C or Hepatitis B.
  • Patients who had received any other investigational drug within 1 month prior to Day 1 of protocol treatment.
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  • Patients with QTc > 450 msec on 12-lead standard electrocardiogram (ECG).
  • Major surgery within 2 weeks prior to protocol treatment.
  • Radiotherapy to > 10% of bone marrow.
  • Patients with 3rd space fluid accumulation (ascites, pleural effusion).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

India7 sites

  • Sri RamaChandra Medical Centre

    Chennai, Tamil Nadu, 600 116

  • Lifeline Mutispecilaity Hospital

    Chennai, Tamil Nadu, 600096

  • Global Hospital

    Hyderabaad, Andhra Pradesh, 500004

  • Meenakshi Mission Hospital & Reasearch Centre

    Madurai, Tamil Nadu, 625107

  • Central India Cancer Research Institute

    Nagpur, Ajayonco@hotmail.com, 440 010

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra, 422 004

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

Other trials in India

About this study

Official title: A Phase I/II Study to Evaluate Safety and Efficacy of P276-00 in Combination With Gemcitabine in Patients With Cancer of Pancreas

The purpose of this study is to identify a dose of P276-00 that can be safely administered along with Gemcitabine and to examine safety and efficacy of the combination in treatment of advanced pancreatic cancer.

Read the detailed description

This study is an open label multicenter trial to evaluate safety and efficacy of P276-00 in combination with Gemcitabine in subjects with locally advanced or metastatic pancreatic cancer. Primary objective in part A is to determine maximum tolerated dose (MTD) of P276-00 in combination with Gemcitabine and in part B to evaluate efficacy of this combination in subjects with locally advanced or metastatic pancreatic cancer. In part A, cohort of 3 subjects will be enrolled at starting dose level of P276-00 which is 100 mg/m2/ day to be given intravenously (IV) from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. If this dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00. P276-00 dose escalation will continue until MTD of P276-00 in combination with Gemcitabine is determined. The subsequent dose levels of P276-00 will be 140 mg/m2/day and 185 mg/m2/day. In part B ten subjects will be evaluated at the MTD of P276-00 in combination with Gemcitabine to evaluate efficacy of the combination. Dose of Gemcitabine will be same in both parts of the study which is 1000mg/m2 over 30mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. Subjects will be treated for six cycles of P276-00 in combination with Gemcitabine or until evidence of disease progression or unacceptable toxicity. Safety evaluations will be performed at regular intervals by means of record of vital parameters, physical examination and laboratory investigations for hematology and biochemistry. Efficacy assessment will be performed by means of weekly record of pain intensity, analgesic consumption, change in weight and performance status for evaluation of clinical benefit response and by means of CT scans at the end of every 2 cycles for evaluation of tumor response by RECIST (Response Evaluation Criteria in Solid Tumors)

Being tested
P276-00, Gemcitabine
Keywords
Locally advanced or metastatic adenocarcinoma of pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • P276-00Drug

    Subjects will be enrolled at different levels of P276-00 dosage as follows:- Level 1 - 100mg/ m 2/day x 5 q 3 weeks Level 2 - 140 mg/ m2/day x 5 q 3 weeks Level 3 - 185 mg/ m2 /day x 5 q 3 weeks P276-00 will be administered as intravenous infusion in 200 ml of 5% dextrose over 30min from days 1 to 5 per 21 day cycle. Six such cycles will be administered unless there is progression of disease or unacceptable toxicity.

  • GemcitabineDrug

    Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m 2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each unless there is progression of disease or unacceptable toxicity.

Study groups in NCT00898287
Study groupRoleWhat they receive
P276-00 plus GemcitabineExperimentalSubjects will be enrolled at different levels of P276-00 dosage as follows:- Level 1 - 100mg/m2/day x 5 q 3 weeks Level 2 - 140 mg/m2/day x 5 q 3 weeks Level 3 - 185 mg/m2/day x 5 q 3 weeks P276-00 will be administered as intravenous infusion in 200 ml of 5% dextrose over 30min from days 1 to 5 per 21 day cycle. Six such cycles will be administered unless there is progression of disease or unacceptable toxicity. Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each unless there is progression of disease or unacceptable toxicity.
Receives: Drug: P276-00; Drug: Gemcitabine

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) of P276-00 administered along with Gemcitabine.

    Measured: 3 weeks

Secondary outcomes (4)

  1. To evaluate pharmacokinetic parameters of P276-00.

    Measured: one week

  2. To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.

    Measured: Every week

  3. To determine objective tumor response rate to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.

    Measured: Every 6 weeks

  4. To characterize toxicities of P276-00 in combination with Gemcitabine.

    Measured: Every week

Timeline

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

  1. First posted12 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2010

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00898287
Sponsor's protocol ID
P276-00/28/08
Other IDs
P276-00/28/08
Acronym
SAVIOR
Status last verified
Jan 2012
First submitted
6 May 2009
Last updated
20 Jan 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing P276-00 and Gemcitabine in people with Pancreatic Cancer, run by Piramal Enterprises Limited at 7 sites in India.

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 14 inclusion and 10 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 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in India. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the maximum tolerated dose (MTD) of P276-00 administered along with Gemcitabine. (time frame: 3 weeks). 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 NCT00898287.

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 20 Jan 2012.

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