Pegylated Liposomal Doxorubicin for Ovarian Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ovarian Cancer+5 MorePegylated Liposomal Doxorubicin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, TTI-622, in combination with an existing cancer drug, Pegylated liposomal doxorubicin. The trial will enroll approximately 50 patients in two phases to test different doses of the new drug.

Eligible Conditions
  • Ovarian Cancer
  • Ovarian Tumors
  • Primary Peritoneal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

20 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Year 1
Identify the Recommended Phase 2 Dose from the Escalation Phase
Year 3
Assess clinical activity of TTI-622 MTD or RP2D in combination with PLD in the Expansion Phase; the disease control rate.
Assess clinical activity of TTI-622 MTD or RP2D in combination with PLD in the Expansion Phase; the immune-related Response Evaluation Criteria in Solid Tumors.
Assess clinical activity of TTI-622 MTD or RP2D in combination with PLD in the Expansion Phase; the other markers of clinical benefit .
Assess clinical activity of TTI-622 maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) in combination with PLD in the Expansion Phase overall response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) .
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; by discontinuations.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; by treatment delays.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; causal relationship of adverse events.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; established MTD
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; frequency of adverse events.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; number of events with changes from baseline in Electrocardiogram (ECG) findings.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; number of events with changes from baseline in laboratory assessments.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; number of events with changes from baseline in vitals signs.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; serious adverse events.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; severity of adverse events.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; timing of adverse events.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 PLD in 28-day cycles in escalation phase; treatment emergent adverse events.
Evaluate safety profile of TTI-622 when administered in combination with 40 mg/m2 Pegylated Liposomal Doxorubicin (PLD) in 28-day cycles in escalation phase; type of adverse events
Percentage of patients experiencing adverse events
Time to progression and new metastases
Time to worsening of Eastern Cooperative Oncology Group (ECOG) performance status
Up to 3 years
Duration of progression-free survival (PFS)
Duration of response
Overall Survival (OS)
Percentage of patients with objective response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Caelyx, Docetaxel, Trastuzumab
59%PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
30%ASTHENIA
30%NAUSEA
26%DIARRHOEA
26%STOMATITIS
22%PYREXIA
22%MUCOSAL INFLAMMATION
19%LEUKOPENIA
19%NEUTROPENIA
15%ALOPECIA
11%CONSTIPATION
11%RASH
11%ABDOMINAL PAIN
11%VOMITING
11%ABDOMINAL PAIN UPPER
11%PARAESTHESIA
7%ONYCHOLYSIS
7%LYMPHOPENIA
7%CHEST PAIN
7%NAIL DISORDER
7%GASTRITIS
7%FATIGUE
7%HEADACHE
7%OEDEMA PERIPHERAL
4%PULMONARY OEDEMA
4%METASTASES TO MENINGES
4%EJECTION FRACTION DECREASED
4%HYPOTENSION
4%COMA
4%SEPSIS
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00687440) in the Caelyx, Docetaxel, Trastuzumab ARM group. Side effects include: PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME with 59%, ASTHENIA with 30%, NAUSEA with 30%, DIARRHOEA with 26%, STOMATITIS with 26%.

Trial Design

2 Treatment Groups

Dose Escalation
1 of 2
Dose Expansion
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Pegylated Liposomal Doxorubicin · No Placebo Group · Phase 2

Dose EscalationExperimental Group · 2 Interventions: Pegylated Liposomal Doxorubicin, TTI-622 · Intervention Types: Drug, Drug
Dose ExpansionExperimental Group · 2 Interventions: Pegylated Liposomal Doxorubicin, TTI-622 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegylated Liposomal Doxorubicin
2005
Completed Phase 3
~910

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Trillium Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
922 Total Patients Enrolled
PfizerLead Sponsor
4,308 Previous Clinical Trials
7,110,785 Total Patients Enrolled
19 Trials studying Ovarian Cancer
2,958 Patients Enrolled for Ovarian Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,280 Previous Clinical Trials
4,820,816 Total Patients Enrolled
11 Trials studying Ovarian Cancer
2,405 Patients Enrolled for Ovarian Cancer
Trillium Study DirectorStudy DirectorTrillium Therapeutics

Eligibility Criteria

Age 18+ · Female Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a cancer patient with a performance status of 0 or 1.
You have a platinum-resistant disease.
Measurable disease per RECIST v1.1.
You have received at least four prior treatment regimens for platinum-resistant disease.

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What state do they live in?
California100.0%
What site did they apply to?
Sarcoma Oncology Research Center, Cancer Center of Southern California100.0%
Why did patients apply to this trial?
  • "My doctor told me she has no more treatments for me unless if there’s any clinical trial that fits me."
How many prior treatments have patients received?
3+100.0%